Commissioning Agents, Inc

Industry: Company

Description

Founded: 1996 Subsidiary: Commissioning Agents International, Inc.

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Commissioning Agents, Inc Employees

Employee
Years
Job
Industry
Charles Busa Charles Busa South Weymouth, Massachusetts Details
Charles Busa's Commissioning Agents, Inc Experience June 2013 - Present
Job Comissioning/ Validation Engineer at Commissioning Agents, Inc
Industry Maritime
Experience
Commissioning Agents, Inc   June 2013 - Present
Integrated Project Services  May 2012 - June 2013
Celebrity Cruises  2009 - August 2012
US Army  May 2001 - May 2007

Skills
Engineering, Maritime, Troubleshooting, Marine Engineering, Inspection, Safety Management..., Power Generation, Military, Firefighting, Electricians, Ships, Weld

Education
Massachusetts Maritime Academy   2005 — 2009
Bachelor's degree, Engineering

Derek Armstrong Derek Armstrong Greater Atlanta Area Details
Derek Armstrong's Commissioning Agents, Inc Experience September 2013 - Present
Job Validation Specialist
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   September 2013 - Present
Charleston Southern University  August 2012 - Present
Bankers Life and Casualty Company  November 2012 - September 2013
US Navy  December 2005 - June 2012
US Navy  January 2006 - September 2008

Skills
Matlab, Microsoft Office, Lean Manufacturing, Nuclear Engineering, Troubleshooting, Calibration, Aerospace, Windows, Quality Assurance, Operational Planning, Microsoft Word, Military Experience, Operations Management, Military Operations, Preventive Maintenance, Maintenance Management, Security Clearance, Testing, Technical Writing, Reactor, Electronics, Engineering, Process Improvement, Computer Hardware, Solidworks, Navy, Labview, PowerPoint, Six Sigma, Supervisory Skills, Power Plants, Analysis, Microsoft Excel, Maintenance & Repair, Team Leadership, Command, Engineering Management, Root Cause Analysis, Power Generation, Mechanical Engineering, Windows 7, Military, Nuclear, Hydraulics, Program Management, Leadership, Process Scheduler, Project Planning, Project Management, DoD

Education
Charleston Southern University   2012 — 2015

Heidi Gaebler Heidi Gaebler Greater Denver Area Details
Heidi Gaebler's Commissioning Agents, Inc Experience April 2013 - Present
Job Validation Engineer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   April 2013 - Present
Tolmar Inc.  February 2008 - April 2013
Tolmar Inc.  November 2006 - February 2008

Skills
Process Validation, Validation, cGMP, Technology Transfer, GMP, FDA, Aseptic Processing, Change Control, Sop, Analytical Chemistry, HPLC, Quality by Design, Cleaning Validation, 21 CFR Part 11, V&V, Manufacturing, Quality Control, Aseptic Technique, Pharmaceutical Industry, Formulation, Biopharmaceuticals, GLP, Quality System, ISO 13485, UV/Vis, Medical Devices, Quality Assurance, Design Control, Regulatory Requirements, Equipment Qualification, SOP

Education
Colorado State University   2000 — 2004
Bachelor's degree, Chemical Engineering

Brian Earley Brian Earley Daytona Beach, Florida Area Details
Brian Earley's Commissioning Agents, Inc Experience June 2014 - June 2015
Job Business Development Manager at Mack Molding Company
Industry Plastics
Experience
Mack Molding Company  September 2015 - Present
Commissioning Agents, Inc   June 2014 - June 2015
Mack Molding Company  April 2012 - May 2014
Mack Molding Company  April 2011 - April 2012
US Navy  February 2003 - February 2011

Skills
Customer Satisfaction, Client Expectations..., Account Management, Program Management, Manufacturing, FDA GMP, Validation, Equipment Commissioning, Continuous Improvement, ISPE, Root Cause Analysis, FMEA, Risk Analysis, Cross-functional Team..., ISO, Process Improvement, Equipment Testing, Laboratory Skills, Lean Manufacturing, Controlled Environments, Troubleshooting

Education
The New School   2005 — 2008
Bachelor of Science (B.S.), Human Resource Management

United States Navy Nuclear Power Program   2003 — 2005
Nuclear Power/ Reactor Plant Chemistry and Radiological Controls

Charles Loeffelholz Charles Loeffelholz Greater Atlanta Area Details
Charles Loeffelholz's Commissioning Agents, Inc Experience October 2013 - Present
Job Production | Operations | Quality | Maintenance and Reliability | Maintenance Management
Industry Machinery
Experience
Commissioning Agents, Inc   October 2013 - Present
Nachukani Craft Works   October 2012 - Present
Oceaneering  June 2012 - November 2012
US Navy  August 2002 - July 2012
US Navy  1982 - 2002

Skills
Quality Assurance, Nuclear, Maintenance Management, Preventive Maintenance, Security Clearance, Root Cause Analysis, Training, Nuclear Engineering, Leadership, Program Management, Power Generation, Military Operations, Six Sigma, Operational Planning, Process Improvement, Top Secret, Military, Quality Management, Military Training, Maintenance & Repair, Supervisory Skills, Organizational..., Project Management, Project Planning, Personnel Supervision, Quality Control, Lean Manufacturing, Management, Machinery, Machinery Repair, Testing, Mechanical Systems, Navy, DoD, Manufacturing, Microsoft Office, Continuous Improvement, Team Building, Operations Management

Education
The New School   1989 — 1991
BS, Human Resources Management

Amanda Grimes Amanda Grimes Warwick, Rhode Island Details
Amanda Grimes's Commissioning Agents, Inc Experience January 2014 - August 2015
Job Sr. Associate Scheduler at Amgen
Industry Biotechnology
Experience
Amgen  August 2015 - Present
Commissioning Agents, Inc   January 2014 - August 2015
Purdue University Card Services Office   June 2012 - August 2012
Maine Standards Co   May 2011 - August 2011
U.S. Navy School Age Center   June 2009 - August 2009

Skills
Microsoft Office, Microsoft Word, Teamwork, Research, Team Leadership, Engineering, Programming, Minitab

Education
Purdue University   2008 — 2013
Bachelor of Science (B.S.), Multidisciplinary Engineering

Erik Shay Erik Shay Greater Pittsburgh Area Details
Erik Shay's Commissioning Agents, Inc Experience March 2011 - June 2011
Job VP Operations, COO at Veka Inc
Industry Building Materials
Experience
Veka Inc  July 2011 - Present
Commissioning Agents, Inc   March 2011 - June 2011
CertainTeed Corporation  February 2007 - March 2011
CertainTeed Corporation  January 2005 - February 2007
CertainTeed Corporation  January 2004 - January 2005
CertainTeed Corporation  February 2003 - January 2004
Corning Incorporated  March 2001 - February 2003
Corning Incorporated  February 1999 - March 2001
Corning Incorporated  February 1998 - February 1999
Corning Incorporated  April 1996 - February 1998

Skills
Project Management, Manufacturing, Process Improvement, Continuous Improvement, Cross-functional Team..., Product Development, Engineering, Root Cause Analysis, Business Development, Product Management, Manufacturing..., Program Management, Nuclear, Lean Manufacturing, Project Engineering, Team Building, Forecasting, Management, Process Engineering, Leadership, Project Planning, Operations Management, Materials Management, P&L Management, Six Sigma, Supply Chain, Engineering Management

Education
Auburn University   2000 — 2002
MS, Business Administration

United States Naval Academy   1983 — 1987
BS, Mechanical Engineering

Robert Melchionda Robert Melchionda Greater Boston Area Details
Robert Melchionda's Commissioning Agents, Inc Experience May 2014 - June 2015
Job Eversource. Program Manager, Energy Efficiency.
Industry Mechanical or Industrial Engineering
Experience
Eversource Energy  June 2015 - Present
Commissioning Agents, Inc   May 2014 - June 2015
Arion Water   September 2011 - April 2014

Skills
Electricians, AutoCAD, PowerPoint, Troubleshooting, Engineering, Power Generation, Microsoft Excel, HVAC, Operations Management, Marine Engineering, Microsoft Word, Power Plants, Boilers, Microsoft Office

Education
Massachusetts Maritime Academy   2012 — 2014
Master of Science (M.S.), Facilities Management

Massachusetts Maritime Academy   2005 — 2010
Bachelor of Science (B.S.), Facilities Engineering

Kathleen (Williams) West Kathleen (Williams) West Indianapolis, Indiana Area Details
Kathleen (Williams) West's Commissioning Agents, Inc Experience March 2012 - September 2012
Job EMS Project Engineer at UISOL, an Alstom Grid Company
Industry Oil & Energy
Experience
UISOL, an Alstom Grid Company   February 2014 - Present
The Structure Group  October 2012 - October 2013
Commissioning Agents, Inc   March 2012 - September 2012
Midwest ISO  February 2008 - August 2011
Exelon  September 2005 - February 2008
Exelon  January 2004 - August 2005
Exelon  June 2003 - December 2003
Exelon  May 2002 - August 2002
Valparaiso University  September 1999 - May 2002
Surfnet Inc   August 1998 - May 2000

Skills
Testing, Power Systems, Engineering, Integration, SCADA, Electric Power, Electrical Engineering, Energy, Power Distribution, Analysis, Programming, Requirements Analysis, Data Analysis, Energy Management, Electricity Markets, Troubleshooting, Problem Solving, Process Improvement, Perl, Technical Writing, Software Quality..., Business Analysis, Databases, Microsoft Office, C, Visio, Excel, Modeling, Linux, PowerPoint, SQL, Access, Windows, Unix, Shell Scripting, Technical Training, Technical Analysis, Technical Documentation, Linear Programming, Computer System..., Power Generation, Consulting, Alstom, Business Travel, Power Transmission, SharePoint, Elicitation, C#, Microsoft Visual Studio, Six Sigma

Education
Illinois Institute of Technology   2004 — 2007
MECE, Power and Control Systems

Valparaiso University   1999 — 2003
BSEE, Electrical Engineering

University of Indianapolis

Zachery Johnson Zachery Johnson Dallas/Fort Worth Area Details
Zachery Johnson's Commissioning Agents, Inc Experience January 2014 - Present
Job Validation Specialist
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   January 2014 - Present
US Navy  February 2010 - January 2014
US Navy  August 2003 - January 2014

Skills
Radiological Controls, Mechanical Maintenance, Nuclear, Navy, Military Experience, Security Clearance, Weapons, Hydraulics, Maintenance, Military, DoD, Nuclear Engineering, Preventive Maintenance, Maintenance Management, Operational Planning, Military Training, Force Protection, Quality Assurance, Troubleshooting, Training

Education
Three Rivers Community College   2011 — 2012
None, Accounting

S.H.A.P.E. American High   2002 — 2003
High School Diploma, Regular/General High School/Secondary Diploma Program

Kit Watson Kit Watson San Diego, California Details
Kit Watson's Commissioning Agents, Inc Experience January 2011 - March 2013
Job Commissioning and Qualification (C&Q) Engineer: The Life Sciences and Nuclear Energy
Industry Pharmaceuticals
Experience
Fourstep Automation, Inc.   August 2013 - Present
San Diego  March 2013 - July 2013
Commissioning Agents, Inc   January 2011 - March 2013
US Navy  December 2000 - November 2009

Skills
Validation, Quality Assurance, Computer System..., Change Control, Sop, FDA, 21 CFR Part 11, Aseptic Processing, Commissioning, Preventive Maintenance, Training, Leadership, Testing, Quality System, GMP, Technical Writing, Equipment Qualification, Software Documentation, Nuclear Engineering, Steam, Quality Control, GAMP, Cleaning Validation, Biopharmaceuticals, Automation, Calibration, CAPA, Sterilization, LIMS, Process Engineering, Continuous Improvement, Root Cause Analysis, Document Management, Biotechnology, Pharmaceutical Industry, Project Management, Validation Master Plans, Risk Assessment, HVAC, Deviations, Clean Rooms, Emerson DeltaV, Building Commissioning, S88, S95, MS Project, P&ID Development, Safety, Earned Value Management, Nuclear

Education
Thomas Edison State College   2003 — 2013
Bachelor of Science, Applied Science: Nuclear Engineering Technologies, 3.233 GPA (116 out of 120 credits complete)

Nuclear Power Training Unit   2002 — 2002
Nuclear Reactor Hands-On Operations Training

Navy Nuclear Power School   2001 — 2002
Nuclear Power Theory, Principles, and Applications

Nuclear Field "A" School   2001 — 2001
Mechanical Theory and Tradeskills

Arizona State University   1999 — 2000
Computer Systems Engineering

Helena High School   1996 — 1999
Graduated with Honors as a National Merit Scholar Finalist, 3.6 GPA

Nikki Bautista, MBA Nikki Bautista, MBA Katy, Texas Details
Nikki Bautista, MBA's Commissioning Agents, Inc Experience 2005 - 2006
Job Project Leadership
Industry Chemicals
Experience
The Dow Chemical Company  January 2015 - Present
The Dow Chemical Company  January 2015 - Present
The Dow Chemical Company  2013 - 2014
The Dow Chemical Company  2012 - 2012
The Dow Chemical Company  2010 - 2012
The Dow Chemical Company  2009 - 2010
The Dow Chemical Company  2008 - 2009
The Dow Chemical Company  2007 - 2008
VECO USA   2006 - June 2007
Commissioning Agents, Inc   2005 - 2006

Skills
Process Engineering, Process Simulation, Process Optimization, HAZOP, Aspen HYSYS, Design of Experiments, P&ID, Petrochemical, Process Control, Six Sigma, Capital Projects, Root Cause Analysis, Engineering Management, SPC, Project Engineering, Entrepreneurship, Leadership, Team Leadership, Cross-functional Team..., Contract Negotiation, Contract Management, Technical Recruiting, Business Strategy, Influence At All Levels, Marketing, Corporate Finance, Managerial Economics, Data Analysis, Organizational..., Marketing Strategy, Mind Mapping, Presentations, Critical Thinking, International Business, Project Management, Management, Capital Budgeting, People Skills, Comparative Analysis, Joint Ventures, International Joint..., Mentoring, STEM, Product Marketing

Education
Babson College   2013 — 2015
Master's degree, Business Administration and Management, Entrepreneurship

Colorado School of Mines   1996 — 2000
Bachelor of Science (BS), Chemical Engineering

Tom Struble Tom Struble Greater Boston Area Details
Tom Struble's Commissioning Agents, Inc Experience July 2011 - Present
Job Client Manager at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   July 2011 - Present
University Mechanical Contractors, Inc.   August 2010 - May 2011
Winslow Design   February 2010 - August 2010
US Navy  October 2007 - October 2009
USS VIRGINIA  December 2004 - September 2007
US Navy  May 2003 - December 2004

Skills
Project Management, Problem Solving, Quality Assurance, HVAC, Nuclear, Commissioning, Validation, Engineering, Energy, Manufacturing, Security Clearance, Leadership, Quality System, MS Project, Management, Training, Process Engineering, Navy, Engineering Management, Energy Efficiency, Project Planning, Program Management, Six Sigma, AutoCAD, Steam, Microsoft Project

Education
Cornell University   1999 — 2003
BS, Geological Engineering

Old Dominion University   2008 — 2009
Masters, Engineering Management

Naval Nuclear Power School & Prototype   2003 — 2004
Nuclear power & engineering

Kirk Calhoun Kirk Calhoun Pueblo, Colorado Area Details
Kirk Calhoun's Commissioning Agents, Inc Experience August 2011 - Present
Job Automation Engineer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   August 2011 - Present
Holcim Inc.  1997 - August 2011

Skills
Commissioning, Quality Assurance, Quality System, GMP, Process Improvement, Validation, Change Control, FDA, Biotechnology, Manufacturing, Automation, Calibration, Sop, Computer System..., Process Engineering

Education
Colorado Technical University
BSIT, Software Engineering

Tiffany Liss Tiffany Liss Indianapolis, Indiana Details
Tiffany Liss's Commissioning Agents, Inc Experience August 2009 - February 2010
Job Digital Marketing Specialist at Belden Inc.
Industry Marketing and Advertising
Experience
Belden Inc.  November 2014 - Present
Belden Inc.  January 2014 - November 2014
RHB  September 2013 - October 2013
STERIS Corporation  November 2012 - July 2013
Knauf Insulation  December 2011 - April 2012
Rexnord Bearing Systems   July 2010 - September 2011
Commissioning Agents, Inc   August 2009 - February 2010
The Buffalo News  April 2007 - January 2009
Safetec of America   2007 - 2008
WUTV Fox 29   January 2003 - September 2006

Skills
Advertising, Online Marketing, SEO, Promotions, Trade Shows, Packaging, Graphic Design, Web Design, Logo Design, Marketing Communications, Email Marketing, Social Media Marketing, Digital Marketing, Marketing Management, Corporate Branding, Brand Awareness, Brand Implementation, New Product Release, New Product Ideas, New Product..., Introducing New Products, Online News, Online Lead Generation, Online Communications, Online Advertising, Retail Packaging, Production Managment, Project Management, Project Coordination, Team Leadership, Leadership Development, Product Marketing, Adobe Creative Suite, Creative Strategy, Creative Direction, Brainstorm Facilitation, Process Scheduler, Process Management, Drafting Policies, ISO Procedures, Art Direction, Online Marketing..., Marketing, Press Releases, Facilitators, Copywriting, Leadership, Strategy, CRM, Brand Management

Education
Columbus College of Art & Design   1991 — 1995
BFA, Advertising Design

Cuyahoga Community College   1997 — 1997
O.P.O.T.A. Certification, Homeland Security, Law Enforcement, Firefighting and Related Protective Services

Justin Denard Justin Denard Fort Collins, Colorado Details
Justin Denard's Commissioning Agents, Inc Experience August 2011 - Present
Job Validation Engineer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   August 2011 - Present
OnCore Manufacturing Services, LLC  June 2011 - August 2011

Skills
Validation, V&V, GMP, Project Management, 21 CFR Part 11, GxP, Installation..., Operational..., Quality System, Sop, CAPA, Change Control, FDA, Microsoft Excel

Education
Colorado State University   2006 — 2011
Major: Mechanical Engineering, Minor: Biomedical Engineering

Whittier College   2005 — 2006

Nicole Granda-Alvarez, LEED AP BD+C Nicole Granda-Alvarez, LEED AP BD+C Puerto Rico area Details
Nicole Granda-Alvarez, LEED AP BD+C's Commissioning Agents, Inc Experience August 2010 - May 2013
Job Process & Validation Consultant
Industry Medical Devices
Experience
Ultimate Solutions Corp.  May 2015 - Present
MENTOR Technical Group Corporation  May 2013 - May 2015
ISPE  March 2013 - December 2014
Commissioning Agents, Inc   August 2010 - May 2013
USGBC Caribbean Chapter   February 2011 - February 2012
V Architecture   September 2009 - December 2009
University of Puerto Rico  August 2007 - May 2009
CaboCoco Corp.   May 2007 - September 2007
CaboCoco Corp.   July 2006 - August 2006

Skills
LEED, LEED AP, Engineering, Architectural Design, Commissioning, Validation, Green Building, CAD, Sustainable Design, Construction Drawings, Project Management, Change Control, GMP, Construction, Sustainability, HVAC, Energy Audits, Renovation, Project Coordination, Proposal Writing, Medical Devices, Architecture, CAPA, Energy Conservation, HVAC Controls, LEED Consulting, Building Commissioning, Energy Efficiency, 21 CFR Part 11, MEP, Energy Management, Building Automation, FDA, Technical Writing, Biotechnology, Water Efficiency, Energy Services, Sustainability..., Sustainable Architecture, GAMP, Project Estimation, Adaptive Reuse, Quality System, Lean Manufacturing, Technology Transfer, V&V, AutoCAD, MS Project, Process Improvement, OSD

Education
Universidad de Puerto Rico   2007 — 2009
Master of Architecture (M.Arch.), Architecture, Suma cum Laude

University of Puerto Rico-Rio Piedras   2003 — 2007
Bachelor of Environmental Design, Architecture, Magna cum Laude

Kerina Epperly Kerina Epperly Indianapolis, Indiana Area Details
Kerina Epperly's Commissioning Agents, Inc Experience August 2013 - April 2014
Job Lean Six Sigma Master Black Belt
Industry Logistics and Supply Chain
Experience
Lean Six Sigma Prowess LLC   November 2014 - Present
RockTenn  April 2014 - December 2014
Commissioning Agents, Inc   August 2013 - April 2014
Nestlé USA  January 2013 - July 2013
Nestle USA  December 2010 - January 2013
Nestle Dreyer's Grand Ice Cream  January 2010 - December 2010
Photronics  June 2008 - 2009
Qimonda  August 2005 - June 2008
Nikon Precision Inc.  August 2000 - 2005
Hynix Semiconductor  July 1997 - August 2000

Skills
Six Sigma, Lean Manufacturing, Kaizen, TPM, Project Management, PDCA, SPC, Continuous Improvement, Design of Experiments, Manufacturing, Process Engineering, Root Cause Analysis, JMP, 5S, Quality System, SMED, Failure Analysis, Data Analysis, Cross-functional Team..., DMAIC, Project Planning, Troubleshooting, Process Improvement, Quality Assurance, FMEA, Quality Control, R&D, Iso 9000, Engineering, Industrial Engineering, ISO, Green Belt, Quality Management, Process Simulation, 5 Why, Minitab, Value Stream Mapping, Quality Auditing, GMP, CAPA, Supplier Quality, Black Belt, Manufacturing..., Manufacturing Operations, Kanban, Automation, Engineering Management, Validation, Testing, Sop

Education
University of Oregon   1995 — 2002
B.S. Science, General Science, Chemistry

Villanova University   2012 — 2013
2013, Master Black Belt Certification

Purdue University   2012 — 2012
Certification in Six Sigma Black Belt - Recertification

Lane Community College   1999 — 2000
A.S. Science, Computer Science, Network Administration

Umpqua Community College   1991 — 1995
A.S. Science, Chemistry & Biology

J. Matthew Garcia J. Matthew Garcia Chandler, Arizona Details
J. Matthew Garcia's Commissioning Agents, Inc Experience March 2014 - April 2015
Job Validation Engineer at Commissioning Agents, Inc | CAI Consulting
Industry Mechanical or Industrial Engineering
Experience
Commissioning Agents, Inc CAI Consulting  April 2015 - Present
Commissioning Agents, Inc   March 2014 - April 2015
Dodgen Optical, LLC   February 2012 - May 2012
Los Robles Hills Winery   May 2011 - August 2011
Truog-Ryding Co. dba The Ryding Co   July 2007 - August 2010

Skills
Solidworks, Engineering Design, Engineering Analysis, Matlab, Bilingual-English/Spanis..., Microsoft Office, CAMWorks, Mechanical Engineering, Mathematics, Cnc, Fluid Mechanics, Design Engineering, Engineering, Design of Experiments, Machining, Finite Element Analysis, Manufacturing, Microsoft Word, AutoCAD, SolidWorks

Education
Northern Arizona University   2011 — 2013
Mechanical Engineering

Moorpark College   2009 — 2011
Mechanical Engineering

California Polytechnic State University-San Luis Obispo   2008 — 2009
Mechanical Engineering

David Tremain David Tremain Hickory, North Carolina Details
David Tremain's Commissioning Agents, Inc Experience June 2014 - Present
Job Validation Specialist at Commissioning Agents, Inc
Industry Program Development
Experience
Commissioning Agents, Inc   June 2014 - Present
Nordson-Xaloy, Inc.   2011 - 2013
Saft  2008 - 2011
Polytron, Inc.   2006 - 2007
Saft  2002 - 2006
Alcatel-Lucent  2001 - 2002
US Navy  1989 - 2001

Skills
Manufacturing, Injection Molding, Root Cause Analysis, Continuous Improvement, Engineering, Design of Experiments, Machine Tools, CAD, Lean Manufacturing, Plastics, Manufacturing..., Process Engineering, Machining, Product Development, SPC, Six Sigma, Process Improvement, Manufacturing..., 5S, FMEA, Kaizen, ISO, Design for Manufacturing

Education
Southern Illinois University, Carbondale   2000 — 2005
Bachelor of Science, Workforce Education & Development

Christa Miller-Shelley Christa Miller-Shelley Rockland, Maine Details
Christa Miller-Shelley's Commissioning Agents, Inc Experience July 2009 - June 2010
Job Deckhand at S/V Victory Chimes
Industry Maritime
Experience
Schooner American Eagle   April 2014 - Present
S/V Victory Chimes   April 2013 - October 2013
Ocean Classroom Foundation  August 2012 - February 2013
AEWC Advanced Structures and Composites Center  August 2010 - August 2012
Commissioning Agents, Inc   July 2009 - June 2010
Thayer School of Engineering  September 2008 - June 2009
Colby Company Engineering  2008 - 2008

Skills
Validation, Matlab, GMP, Biotechnology, Change Control, Quality Assurance, Sop, FDA, Technical Writing, GAMP, Commissioning, MathCAD, Solidworks, Microsoft Office, Microsoft Project, Photoshop, Project Management, Fiber Reinforced...

Education
University of Maine   2010 — 2012
M.S., Civil Engineering

Dartmouth College   2006 — 2009
B.E., Engineering

Colby College   2004 — 2008
B.A., Physics

Sean Magee Sean Magee Greater Denver Area Details
Sean Magee's Commissioning Agents, Inc Experience September 2012 - January 2013
Job Senior Manager at AntriaBio, Inc.
Industry Biotechnology
Experience
AntriaBio, Inc.   August 2014 - Present
TOLMAR Inc.  January 2014 - July 2014
Amgen  January 2013 - December 2013
Commissioning Agents, Inc   September 2012 - January 2013
Human Genome Sciences  July 2010 - April 2012
Human Genome Sciences  April 2006 - June 2010
Human Genome Sciences  May 2004 - March 2006
Human Genome Sciences  June 2002 - May 2004
The Biotechnology Resource   March 2001 - May 2002
INDOOR Biotechnologies Inc   May 2001 - August 2001

Skills
QUMAS, Bioreactor, Trackwise, Microsoft Office, MS Project, Software, Technology Transfer, GMP, Validation, Biotechnology, Biopharmaceuticals, Sop, CAPA, WebDAV, V&V, Purification, FDA, GLP, Chromatography, Fermentation, Cell Culture, Process Simulation

Education
James Madison University   1998 — 2002
Bachelor of Science, Integrated Science and Technology, 3.3

Kristen Stoner Kristen Stoner Portland, Oregon Area Details
Kristen Stoner's Commissioning Agents, Inc Experience July 2012 - Present
Job Validation Engineer at Commissioning Agents Inc.
Industry Biotechnology
Experience
Commissioning Agents, Inc   July 2012 - Present
Commissioning Agents, Inc CAI Consulting  2013 - 2015
Commissioning Agents, Inc CAI Consulting  2012 - 2013
AVI BioPharma  November 2010 - August 2012
The Ohio State University  June 2010 - October 2010
The Ohio State University  June 2009 - August 2009
Oregon State University  June 2008 - June 2009
ON Semiconductor  June 2007 - September 2007

Skills
HPLC, Purification, Microsoft Office 2007, Validation Engineering, Automation Engineering, Process Validation, Good Documentation..., Good Manufacturing..., Equipment Qualification, Analytical Method..., Quality Systems Design, Aseptic Processing, Assay Development, Protein Chemistry, Validation, Chemistry, Molecular Biology, Mass Spectrometry, GMP, Pharmaceutical Industry, Biotechnology

Education
Oregon State University   2005 — 2010
BS, Bioengineering with Honors

Matt Warhover Matt Warhover Greater St. Louis Area Details
Matt Warhover's Commissioning Agents, Inc Experience April 2004 - Present
Job Project Manager
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   April 2004 - Present
US Navy  April 1998 - April 2004

Skills
Fillers, Lyophilization, Risk Management, Quality Assurance, Validation, Testing, Commissioning, Project Management, Project Planning, Troubleshooting, Risk Assessment, Process Engineering, Nuclear Medicine, Training, Quality System, Computer System..., 21 CFR Part 11, GMP, GAMP, V&V, Change Control, Cleaning Validation, Sop, CAPA, Inspection, PLC, GxP, Technology Transfer, Process Simulation, Root Cause Analysis, Biopharmaceuticals, SOP

Education
Thomas Edison State College   2012 — 2014
Bachelor of Applied Science and Technology (B.A.S.T.), Nuclear Energy Engineering Technology (in progress), Senior

Navy Nuclear Power School   1998 — 1999

Tim Stark Tim Stark Raleigh-Durham, North Carolina Area Details
Tim Stark's Commissioning Agents, Inc Experience October 2013 - Present
Job Engineer at Commissioning Agents, Inc
Industry Biotechnology
Experience
Commissioning Agents, Inc   October 2013 - Present
North Carolina State University  August 2012 - Present
St. Jude Children's Research Hospital   2013 - 2013
Biogen Idec  2013 - 2013
Kessler Design + Build   January 2005 - December 2008
1-800-GOT-JUNK?  January 2003 - December 2008
Bluefield State College  January 1999 - December 2001
Old Masonic Lodge   January 1994 - January 2001
ING Barings  March 1999 - October 1999

Skills
Project Management, Process Management, Facilities Engineering, Facility Development, FDA GMP, CAPA, Bioassay, Aseptic Processing, Microbiology, Biotechnology, Cell Biology, Aseptic Technique, Problem Solving, Customer Service, Strategic Planning, Construction, Protein Purification, SDS-PAGE

Education
Princeton University   1982 — 1986
Bachelor of Science, Organic Chemistry

Marshall University   1992 — 1993
Master of Science, General and Plant Biology

North Carolina State University   2012 — 2015
Master's degree, Biomanufacturing

James Gaines James Gaines Greater Los Angeles Area Details
James Gaines's Commissioning Agents, Inc Experience March 2011 - Present
Job Validation Specialist at Commissioning Agents, Inc
Industry Military
Experience
Commissioning Agents, Inc   March 2011 - Present
US Navy  December 1998 - February 2011

Skills
Preventive Maintenance, Validation, Quality Assurance, Commissioning, Engineering, Testing, Quality System, Inspection, Troubleshooting, Nuclear, Project Planning, Computer System..., Calibration, GMP, 21 CFR Part 11

Education
Keller Graduate School of Management of DeVry University   2013 — 2015
Master of Business Administration (MBA), Project Management

DeVry University-California   2012 — 2013
Bachelor of Science Technical Management, Concentration in project management

Trinity Grammar and Prep   1995 — 1998
High School Diploma

Lisa Schuster Lisa Schuster San Francisco Bay Area Details
Lisa Schuster's Commissioning Agents, Inc Experience 2001 - 2006
Job Software Validation Engineer
Industry Pharmaceuticals
Experience
US Data Management, LLC   May 2014 - Present
Lisa Schuster Consulting   November 2012 - Present
Care Innovations™, an Intel-GE Company   August 2013 - March 2014
Dendreon  July 2010 - September 2012
Safis Solutions, LLC  March 2006 - July 2010
Commissioning Agents, Inc   2001 - 2006
General Motors Advanced Technology Vehicles - Continental Design Contractor   2000 - 2001
at Magenquench - Continental Design Contractor   1993 - 2000
Delco Remy Division, General Motors   1983 - 1989
Allied Fibers and Plastics (now Honeywell)   1982 - 1983

Skills
Computer System..., 21 CFR Part 11, Part 820, ISO 14971, ISO 13485, NDA, CMC development, eCTD, Equipment Qualification, Engineering Statistics, Clean Rooms, Delta V, C++, Electronic Signatures, Taguchi, Shainin, Design of Experiments, Cpk, Process Capability, Gage R & R, FDA, Validation, Quality System, Change Control, CAPA, GMP, Quality Assurance, Quality Auditing, Regulatory Affairs, Medical Devices, GxP, Process Simulation, Software Documentation, Biotechnology, ISO, Regulatory Requirements, Process Engineering, GAMP, Testing, V&V, Biopharmaceuticals, GLP

Education
Case Western Reserve University   1978 — 1982
B.S., Chemical Engineering

Dean Priebe Dean Priebe Greater Boston Area Details
Dean Priebe's Commissioning Agents, Inc Experience October 1997 - March 2000
Job Director, Simultaneous & Partnered Engineering (SPE)
Industry Logistics and Supply Chain
Experience
C&S Wholesale Grocers  April 2014 - Present
C&S Wholesale Grocers  August 2013 - April 2014
Smiths Medical  October 2011 - May 2013
NNE Pharmaplan  March 2010 - October 2011
International Society for Pharmaceutical Engineers   1997 - 2011
Covidien  April 2007 - March 2010
Novartis  March 2000 - April 2007
Commissioning Agents, Inc   October 1997 - March 2000
Performance Validation  October 1995 - October 1997
US Navy  October 1989 - October 1995

Skills
Safety Management..., FDA GMP, Operations Management, Program Management, Project Management, Operational Excellence, Lean Thinking, Change Management, Development & delivery..., Pharmaceutical Industry, Medical Devices, GMP, FDA, Six Sigma, Process Improvement, Lean Manufacturing, Cross-functional Team..., Training, Engineering, Software Documentation, CAPA, Root Cause Analysis, Value Stream Mapping, Quality System, Continuous Improvement, ISO 13485, Validation, Management, Manufacturing, V&V, 21 CFR Part 11, Quality Assurance, DMAIC, Leadership, ISO, Design of Experiments, Change Control, Quality Management, Computer System..., Product Development, Quality Control, Sop, Design Control, Process Engineering, Biotechnology, R&D, Quality Auditing, SPC, Technology Transfer, Process Simulation

Education
The University of Connecticut School of Business   2004 — 2006
Masters, MBA

Thomas Edison State College   2003 — 2004
BS, Nuclear Engineering

Southern Illinois University, Carbondale   2001 — 2004
BS AST, Workforce Education, Training, and Development

Andy Kuvent Andy Kuvent Greater Boston Area Details
Andy Kuvent's Commissioning Agents, Inc Experience May 2012 - Present
Job Project Manager/Plant Engineer at Commissioning Agents Inc.
Industry Pharmaceuticals
Experience
Commissioning Agents Inc.  May 2012 - Present
Commissioning Agents, Inc   October 2011 - Present
Commissioning Agents Inc.  August 2005 - Present
Commissioning Agents Inc.  November 2014 - Present
Commissioning Agents, Inc   January 2014 - October 2014

Skills
Computer System..., FDA, Commissioning, Validation, GMP, Technology Transfer, CAPA, Change Control, 21 CFR Part 11, Biotechnology, Sop, Biopharmaceuticals, Software Documentation, V&V, Pharmaceutical Industry, GxP, GAMP, GLP, LIMS, Quality Assurance, Process Simulation, Chromatography, Aseptic Processing, Quality Control, SOP

Education
Thomas Edison State College
BS in Nuclear Engineering

Deering High School   1977 — 1979
College Prep

Dexter Regional High School   1975 — 1977
college prep

Alyse Goupil Alyse Goupil Broomfield, Colorado Details
Alyse Goupil's Commissioning Agents, Inc Experience March 2014 - Present
Job Validation Engineer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   March 2014 - Present
New Belgium Brewing  May 2013 - March 2014
ChemE Car  September 2009 - May 2013
Sandoz  2012 - 2012

Skills
Excel, Microsoft Office, PowerPoint, Word, Matlab, Polymath, Hazardous Waste Training, Microsoft Excel, Research, GMP, Engineering, Customer Service, Quality Assurance, Technical Writing

Education
Colorado State University   2009 — 2013
Bachelor of Science, Chemical and Biological Engineering

Edward Reich, P.E. Edward Reich, P.E. Perry Hall, Maryland Details
Edward Reich, P.E.'s Commissioning Agents, Inc Experience February 2013 - Present
Job Senior Engineer at CAI, inc
Industry Chemicals
Experience
Commissioning Agents, Inc   February 2013 - Present
RG-Steel  2008 - 2012
RG-Steel  2008 - 2012
RG-Steel  2008 - 2012
Jacobs Technology (ATSS)   2007 - 2008
Bechtel Government Services  2006 - 2007
Bechtel Government Services  2004 - 2006
Tourgee & Associates, Inc.   1996 - 2004
TAI Engineering  1996 - 2004
TAI Engineering  2001 - 2002

Skills
Project Management, Project Risk, MS Project, MBA, SOW, Point of Contact, Financial Analysis, Financial Modeling, Cross-functional Team..., Business Ethics, Procurement, Reliability Engineering, RCM, FMEA, OEE, Lean Management, Continuous Improvement, Process Engineering, Process Improvement, Procedure Development, Technology..., Engineering Calculations, HSE Management Systems, Process Safety, Manufacturing, Engineering, Technical Writing, Accident Investigation, Inspection, Factory, Pumps, Preventive Maintenance

Education
UMBC   2013 — 2015
Master's of Professional Studies, Biotechnology

Strayer University-Maryland   2009 — 2011
Master of Business Administration (MBA), Project Management, 4.0

University of Maryland College Park
Bachelor of Science (BS), Chemical Engineering, 3.2

Julie Stoelting, MS Empl Law, CSSGB, PHR Julie Stoelting, MS Empl Law, CSSGB, PHR Indianapolis, Indiana Area Details
Julie Stoelting, MS Empl Law, CSSGB, PHR's Commissioning Agents, Inc Experience July 2011 - October 2011
Job Human Resource Business Consultant at St.Vincent Health
Industry Human Resources
Experience
St.Vincent Health  May 2015 - Present
Indiana Wesleyan University  September 2014 - Present
Ascension Health  October 2011 - Present
360JobInterview.com   2011 - Present
Commissioning Agents, Inc   July 2011 - October 2011
Ascension Heath-Ajilon   March 2011 - May 2011
Premiere Credit of North America  March 2008 - December 2010
Steak n Shake  1992 - 2007

Skills
Recruiting, Onboarding, Employee Relations, Benefits Administration, Talent Acquisition, Human Resources, Personnel Management, Training, Program Management, Policy, Workforce Planning, Interviews, Employee Benefits, Leadership, Process Improvement, Coaching, Hiring, Labor Relations, Resume Writing, Performance Management, Management, Employee Training, Temporary Placement, Payroll, Strategy, Sourcing, Talent Management, HRIS, Applicant Tracking..., College Recruiting, Deferred Compensation, Employee Engagement, Organizational..., Succession Planning, New Hire Orientations, PeopleSoft, Technical Recruiting, HR Consulting, Career Development, HR Policies, FMLA, Organizational..., Leadership Development, Internet Recruiting, Job Descriptions, Executive Search, Employer Branding, Employment Law, Conflict Resolution, Job Coaching

Education
Nova Southeastern University Shepard Broad College of Law   2011 — 2013
MS, Employment Law

Purdue University   1981 — 1986
BS, Restaurant Management, business option

Bloomington North High School

Nicholas Butterbaugh Nicholas Butterbaugh Sacramento, California Area Details
Nicholas Butterbaugh's Commissioning Agents, Inc Experience January 2014 - Present
Job Validation Scientist at Commissioning Agents, Inc
Industry Biotechnology
Experience
Commissioning Agents, Inc   January 2014 - Present
Commissioning Agents, Inc   February 2012 - December 2013
North Carolina State University  May 2009 - December 2011
Novozymes  May 2011 - August 2011
UNC Charlotte  May 2007 - March 2011
Plants for Human Health Institute  May 2010 - August 2010
David H. Murdock Reserach Institute   May 2009 - August 2009

Skills
SIP Validation, Microbiology, Analytical Chemistry, Molecular Biology, Validation, GMP, Cell, Microscopy, Laboratory, Aseptic Technique

Education
North Carolina State University   2007 — 2011
B.S., Bioprocessing Science

Jay M. Robinson High School   2003 — 2007

Brendan Cameron Brendan Cameron Raleigh-Durham, North Carolina Area Details
Brendan Cameron's Commissioning Agents, Inc Experience September 2013 - Present
Job Validation Specialist at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   September 2013 - Present
Brody School of Medicine  September 2012 - December 2012
Gold Sealing   May 2007 - August 2010

Skills
Biotechnology, Purification, Cleaning Validation, 21 CFR Part 11, Computer System...

Education
East Carolina University   2007 — 2012
Bachelor of Science (BS), Exercise Physiology/Biology

Capstone Center Validation Academy

Lindsay Van Ness Lindsay Van Ness Greater Atlanta Area Details
Lindsay Van Ness's Commissioning Agents, Inc Experience October 2012 - July 2014
Job Validation Engineer at Baxter International
Industry Biotechnology
Experience
Baxalta  July 2014 - Present
Commissioning Agents, Inc   October 2012 - July 2014
Dendreon Corporation  January 2011 - October 2012
Dendreon  October 2009 - December 2010
Dendreon  August 2009 - October 2009
On Assignment  March 2009 - July 2009
University of Rochester Medical Center  June 2008 - February 2009

Skills
Quality Control, GMP, Training, LIMS, Sop, Validation, FDA, Quality System, 21 CFR Part 11, Quality Assurance, Biotechnology, Pharmaceutical Industry, Microbiology, UV/Vis, ELISA, Flow Cytometry, Endotoxin, Gram Staining, Assay Development, Laboratory, PCR, Gel Electrophoresis, SOP

Education
Rochester Institute of Technology   2006 — 2009
Bachelor of Science, Biotechnology

Sussex County Community College   2004 — 2006
Associate of Science, Biology

David Yaffe, CPIP David Yaffe, CPIP Raleigh-Durham, North Carolina Area Details
David Yaffe, CPIP's Commissioning Agents, Inc Experience September 2000 - Present
Job Project Manager For Commissioning Agents Inc.
Industry Pharmaceuticals
Experience
Commissioning Agents Inc.  September 2000 - Present
US Navy  July 1980 - November 2000

Skills
Sop, Validation, GMP, Project Planning, FDA, Quality Assurance, Quality System, Process Engineering, Change Control, V&V, Root Cause Analysis, CAPA, Change Management, Navy, Commissioning

Education
The New School   1988 — 1990
BS, Human Resources Management

Massasoit Community College   1977 — 1979
AS, Business Administration

Eric Collier Eric Collier Grovetown, Georgia Details
Eric Collier's Commissioning Agents, Inc Experience May 2013 - Present
Job Validation Scientist at Commissioning Agents, Inc
Industry Biotechnology
Experience
Commissioning Agents, Inc   May 2013 - Present
Commissioning Agents, Inc CAI Consulting  May 2013 - June 2014
Elanco  April 2007 - May 2013
CSC  January 2006 - April 2007
ITT  April 2004 - January 2006
Pfizer  November 1999 - April 2004
Stanford Telecom  May 1991 - November 1999
US Army  June 1990 - April 1991
US Army  September 1987 - June 1990
US Army  January 1986 - August 1987

Skills
Software Application..., Enterprise Architecture, Systems Engineering, Data Modeling, ETL, Computer System..., Software Configuration..., Software Quality..., Java, Java Enterprise Edition, PL/SQL, C++, Visual Basic, .NET, VMS, Linux, Solaris, MySQL, Microsoft SQL Server, GAMP, CMMI, IEEE standards, GMP, Software Development, Validation, Requirements Analysis, SharePoint, Databases, SDLC, Oracle, Software Project..., UML, XML, Software Engineering, Agile Methodologies, Business Analysis, Requirements Gathering, Web Applications, Disaster Recovery, Cross-functional Team..., Data Warehousing, Testing, FDA, Quality Assurance, Change Control

Education
Limestone College
Bachelor of Science, Computer Science

Daniel Hogan, CPVP Daniel Hogan, CPVP Indianapolis, Indiana Details
Daniel Hogan, CPVP's Commissioning Agents, Inc Experience March 2012 - January 2015
Job Senior Validation Scientist / Project Manager at Commissioning Agents, Inc | CAI Consulting
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc CAI Consulting  January 2015 - Present
Commissioning Agents, Inc   March 2012 - January 2015
Sentry BioPharma Services, Inc.   February 2011 - February 2012
Sentry BioPharma Services, Inc.   November 2010 - February 2012
Abbott Laboratories  June 2009 - August 2009
DePauw University, Lab of Microbiology   January 2009 - May 2009
Abbott Laboratories  May 2008 - August 2008
Manpower Inc.  May 2007 - August 2007

Skills
Validation, GMP, Laboratory, Sop, Quality System, V&V, Life Sciences, Quality Assurance, Cell Culture, Process Validation, FDA, Commissioning, CAPA, 21 CFR Part 11, Change Control, HPLC, Research, Computer System..., Aseptic Processing, Microsoft Excel, GAMP, Internal Audit, Software Validation, Biotechnology, Biochemistry, Molecular Biology, Microbiology, Chromatography, Pharmaceuticals, Medical Devices, Word, Chemistry, Compliance, Quality Systems, R&D, Equipment Qualification, Analytical Method..., Cleaning Validation, Biopharmaceuticals, GxP, Technical Writing, Design Control, Sterilization Validation, Pharmaceutical process..., Temperature Mapping, Critical Utilities, Component Processing..., Formulation, Quality Auditing, SOP

Education
DePauw University   2006 — 2010
B.A., Biochemistry

Hartland High School   2002 — 2006

Dorn Parker Dorn Parker Greater Philadelphia Area Details
Dorn Parker's Commissioning Agents, Inc Experience December 2005 - February 2009
Job Process Validation Engineer Contract Merck
Industry Biotechnology
Experience
Associated Staffing  January 2013 - Present
Oxford Global Resources  September 2012 - December 2012
Insight Global  July 2012 - August 2012
Validation Technologies, Inc.   May 2012 - July 2012
Enterprise System Partners Limited  December 2010 - May 2012
JM Hyde Consulting  July 2010 - February 2011
Validation Engineer – Bukovac and Duncan TG 2010 to Present   April 2010 - June 2010
Techsource2009 to 2010   December 2009 - January 2010
Commissioning Agents, Inc   December 2005 - February 2009
Millennium Validation Services   March 2004 - October 2005

Skills
DeltaV, Allen Bradley, Commissioning, CIP, DCS, Wonderware, Start-ups, Biotechnology, ControlLogix, PLC, SCADA, Instrumentation, Change Control, Equipment Qualification, Equipment Commissioning, PI Data Historian, Deviation Investigation, Validation, GMP, V&V, Sop, WebDAV, Quality Assurance, Automation, Quality System, Process Control, Deviations, Pharmaceutical Industry, Control Logic, Engineering, Cleaning Validation, Quality Control, 21 CFR Part 11, Calibration, CAPA, GxP, Testing, FDA

Education
Waukesha County Technical College   1979 — 1981
Associate, Electronics

Community College of Philadelphia
Associate's degree, Engineering Science

David Plathe David Plathe Greater Boston Area Details
David Plathe's Commissioning Agents, Inc Experience January 2014 - Present
Job Critical Engineering Operations Manager
Industry Military
Experience
DTZ, a UGL company  June 2015 - Present
Commissioning Agents, Inc   January 2014 - Present
DP Engineering  November 2007 - December 2013
Contrack International Inc  August 2006 - December 2012

Skills
Construction, Engineering, Contract Negotiation, Construction Management, Civil Engineering, Commissioning, Primavera P6, Project Estimation, Contractors, Procurement, Concrete, EPC, Facilities Management, Inspection, Project Control, Value Engineering, Pre-construction, Supervisory Skills, Project Coordination, CPM Scheduling, Construction Safety, Proposal Writing, Electricians, Safety Management..., MEP, Quality Control, Subcontracting, LEED, Feasibility Studies, Program Management, Contract Management, Electrical Engineering, Military, Project Engineering, MS Project, HVAC, Leadership, Power Plants, Process Scheduler, Materials, Water, AutoCAD, Cost Control, Fire Alarm, Structural Engineering, Change Orders, HVAC Controls, Project Planning, Power Generation, Piping

Education
Massachusetts Maritime Academy   1998 — 2005
BS, Facilities and Environmental Engineering

Chris Leland, MBA Chris Leland, MBA Indianapolis, Indiana Area Details
Chris Leland, MBA's Commissioning Agents, Inc Experience August 2011 - March 2015
Job Product Architect at DataVoke, Inc.
Industry Pharmaceuticals
Experience
DataVoke, Inc.   August 2015 - Present
DataVoke, Inc.   March 2015 - Present
Commissioning Agents, Inc   August 2011 - March 2015
AWP, Inc.   April 2010 - March 2011
Dynamic Engineering Design   February 2008 - March 2010
SITUS Realty Corp.   2007 - 2008
Pyramid Design & Construction   December 2000 - May 2007

Skills
Project Management, Data Analysis, Budgets, Spreadsheets, Microsoft Excel, Process Improvement, Microsoft Office, Project Planning, Team Building, Risk Management, PowerPoint, Change Management, Microsoft Word, Management

Education
Butler University   2011 — 2014
Master of Business Administration (M.B.A.)

Indiana University-Purdue University at Indianapolis   2003 — 2009
BA, Economics

Triton Central HS

Mike Schoellman Mike Schoellman Indianapolis, Indiana Area Details
Mike Schoellman's Commissioning Agents, Inc Experience June 2003 - Present
Job Project Manager at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   June 2003 - Present
FSSI @ Plum Island Animal Disease Research Center   2002 - 2004
Plum Island Animal Disease Center  March 2002 - July 2003
US Navy  1976 - 1996

Skills
Commissioning, Navy, Computer System..., Power Generation, Nuclear, Steam, Change Control

Education
Texas A&M University   1996 — 2001
BS, Mechanical Engineering

Matthew Osburn, PMP Matthew Osburn, PMP Indianapolis, Indiana Area Details
Matthew Osburn, PMP's Commissioning Agents, Inc Experience September 2009 - Present
Job Validation Engineer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   September 2009 - Present
Marquette University  August 2007 - September 2009
United States Navy  May 2003 - September 2009
United States Navy  October 2004 - August 2007

Skills
Navy, Security Clearance, Military, Process Improvement, Validation, Root Cause Analysis, Quality Assurance, GMP, Project Management, Quality System, Nuclear, Leadership, DoD, Engineering, Military Experience, Strategic Planning, Process Engineering, Management, Technical Writing

Education
Marquette University   2007 — 2009
Masters of Science, Engineering Management

University of Notre Dame   1999 — 2003
Bachelor of Science, Mechanical Engineering

Project Management Institute
Project Management Professional, PMP

Rockwell Automation
Certified ControlLogix Programmer

Olesia Solomatina Olesia Solomatina Washington, District Of Columbia Details
Olesia Solomatina's Commissioning Agents, Inc Experience December 2011 - June 2013
Job Manufacturing Manager, CMC at Vanda Pharmaceuticals
Industry Pharmaceuticals
Experience
Vanda Pharmaceuticals  July 2013 - Present
Commissioning Agents, Inc   December 2011 - June 2013
Merck  November 2009 - November 2011
Vanda Pharmaceuticals  January 2008 - December 2008
Purdue Pharma  March 2006 - January 2008

Skills
Validation, Sop, Pharmaceutics, CAPA, Management, Quality Control, Computer System..., GMP, Software Documentation, V&V, Manufacturing, Quality System, Cleaning Validation, Analysis, Training, FDA, SAP, Automation, Commissioning, Project Planning, 21 CFR Part 11, Quality Assurance

Education
University of Rhode Island   2002 — 2005
Bachelor of Applied Science (BASc), Chemical and Ocean Engineering

Northeastern University   2001 — 2002
Chemical Engineering

Joseph Pichette Joseph Pichette Santee, California Details
Joseph Pichette's Commissioning Agents, Inc Experience September 2012 - April 2015
Job Process Engineer at CRB
Industry Higher Education
Experience
CRB  April 2015 - Present
Commissioning Agents, Inc   September 2012 - April 2015
UC Riverside  2011 - 2012

Skills
Matlab, Data Analysis, GMP, Programming, Validation, Technical Writing, Pharmaceutical Industry, HPLC, Lifesciences, Sop, Microsoft Office, Biotechnology, Quality Assurance, Cell Culture, Analytical Chemistry, FDA, Research, Quality System

Education
University of California, Riverside   2009 — 2012
B.S. Chemical Engineering, Engineering

Grossmont College   2007 — 2009
NA, General Education

Aaron Roth Aaron Roth Albany, New York Area Details
Aaron Roth's Commissioning Agents, Inc Experience July 2012 - Present
Job Validation Engineer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   July 2012 - Present
US Navy  June 2010 - June 2012
US Navy  March 2009 - June 2010
US Navy  November 2006 - March 2009

Skills
Commissioning, Qualification Testing, Thermodynamics, Electrical Engineering, Project Management, Maintenance Management, Nuclear Engineering, Military Operations, National Security, Operational Planning, Maritime Operations, Engineering, Reactor, Navy, Nuclear, Testing

Education
Rensselaer Polytechnic Institute   2001 — 2005
B.S., Physics

Babylon Jr/Sr High School

Babylon Jr/Sr High School

Babylon Jr/Sr High School

Dave Parta P.E., PMP, CSM Dave Parta P.E., PMP, CSM Greater Chicago Area Details
Dave Parta P.E., PMP, CSM's Commissioning Agents, Inc Experience 2012 - 2013
Job Senior International Engineering Project Manager & Director : ElectroMechanical Systems & Devices :
Industry Mechanical or Industrial Engineering
Experience
TGW Systems Inc.  2015 - Present
Project Management Institute - Chicagoland Chapter   2005 - Present
Wheaton Executive Network   2004 - Present
Gray Hair Management   2003 - Present
WestSpring International   1997 - Present
Project Management Institute  1995 - Present
Naperville Flying Club   1990 - Present
Fortna  2013 - 2014
Commissioning Agents, Inc   2012 - 2013
GE Intelligent Platforms - Asset Intelligence [SmartSignal]   2008 - 2012

Skills
Aerospace/Defense, Budgeting, Business Analysis, Business Process..., Certified Project..., Change Management, Coaching, Construction, Construction Management, Contract Management, Contract Negotiation, Cross-functional Team..., Customer Relations, Earned Value Management, Engineering, Engineering Management, Material Handling, Mentoring, Microsoft Excel, Microsoft Office, MS Project, Negotiation, Planning, PMI, PMP, PowerPoint, Problem Solving, Process Engineering, Process Improvement, Program Management, Project Coordination, Project Engineering, Project Execution, Project Finance, Project Implementation, Project Management, Project Planning, Proposal Writing, PMO, Power Generation, Resource Management, Risk Management, Scheduling, Scope Management, Strategic Planning, Team Building, Team Leadership, Quality Assurance, Quality Management, Start-ups

Education
Directions   2014 — 2015

Chicago Deming Association
Lean Six Sigma Green Belt

Keller Graduate School of Management of DeVry University
Master's Degree, Project Management

Loyola University of Chicago
MBA

University of Michigan
BSE-ME, Mechanical Engineering

Novi High School
college preparatory

DJ Callahan DJ Callahan Indianapolis, Indiana Area Details
DJ Callahan's Commissioning Agents, Inc Experience August 2014 - Present
Job Validation Specialist / Project Manager
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   August 2014 - Present
Industrial Electric  November 2013 - August 2014
Industrial Electric  December 2009 - November 2013
IBEW 481  August 2004 - November 2009

Skills
Blueprint Reading, Electrical Safety, Electricity, Wiring, Electrical Controls, Instrumentation, Construction, Construction Safety, Fire Alarm, Low Voltage, Power Distribution, Switchgear, High Voltage, Transformer, PLC, Motor Control, Industrial Control, Pneumatics, Allen Bradley, Building Automation, Construction Management, DCS, Variable Frequency..., Building Management..., Project Management

Education
Ivy Tech Community College
Associate of Science (A.S.), Technology

Oakland City University
Bachelor of Science (B.S.), Management

Jennifer Lauria Clark, CPIP Jennifer Lauria Clark, CPIP Charleston, South Carolina Area Details
Jennifer Lauria Clark, CPIP's Commissioning Agents, Inc Experience January 2013 - Present
Job Director of Technical Services and KAM Program at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   January 2013 - Present
ISPE  2003 - Present
Biotech Company  2012 - 2012
Biotech Company  June 2011 - December 2011
Yonkers Industries, Inc  February 2007 - November 2011
OSD Facility   2007 - January 2009
Client  2007 - 2008
AMEC BioPharmaceuticals  2005 - 2007
Key Club and Circle K International   1996 - 2005

Skills
General Utility..., FDA, Validation, GMP, V&V, Sop, Biotechnology, Change Control, Pharmaceutical Industry, Process Simulation, Quality Assurance, Quality System, CAPA, Process Engineering, Commissioning, GLP, Technical Writing, Software Documentation, Microbiology, LIMS, Aseptic Processing, Cross-functional Team..., Manufacturing, Project Management, Lifesciences, Cleaning Validation, Computer System..., 21 CFR Part 11, Testing, GAMP, GxP, SOP, Life Sciences, Technology Transfer

Education
North Carolina State University   2000 — 2005
BS, Industrial Engineering

Wake Forest-Rolesville High School   1996 — 2000

Caleb Eljach Caleb Eljach Greenville, South Carolina Area Details
Caleb Eljach's Commissioning Agents, Inc Experience November 2013 - October 2014
Job Technical Account Manager at Stueken LLC
Industry Biotechnology
Experience
Stueken LLC  February 2015 - Present
Commissioning Agents, Inc   November 2013 - October 2014
Clemson University  May 2012 - August 2013
Clemson University  August 2011 - May 2013

Skills
Fluent in English and..., Solid Works, Excellent communication..., OrthoPOD pin-on-disk..., CETR UMT-2 Tribometer, Veeco Wyko Non-contact..., Bioengineering, Biomechanics, Biomaterials, Management, Customer Service, Orthopedic, Tribology, Surface Analysis, Biomedical Engineering, Mechanical Testing, Fluorescence Microscopy, Scanning Electron..., Tissue Engineering, Microscopy, SolidWorks, Solidworks

Education
Clemson University   2012 — 2013
Master's degree, Bioengineering

Clemson University   2008 — 2012
Bachelor of Science (B.S.), Bioengineering

Amy Bradford Amy Bradford Greater St. Louis Area Details
Amy Bradford's Commissioning Agents, Inc Experience February 2014 - Present
Job Validation Scientist at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   February 2014 - Present
New Link Genetics   December 2013 - February 2014
Oxford Global Resources  November 2011 - December 2012
Reckitt Benckiser  January 2010 - November 2012
Wyeth bioPharma  August 2000 - May 2004
bioMerieux  1995 - 2000

Skills
GMP, Validation, FDA, Microbiology, Cleaning Validation, GLP, V&V, Quality System, R&D, Pharmaceutical Industry, Medical Devices, Change Control, Personal Care, QA/QC, CAPA, Quality Assurance, Technology Transfer, Quality Management, Manufacturing, Sop, 21 CFR Part 11, Aseptic Processing, Regulatory Affairs, Quality Control, Quality Auditing, Project Planning, Project Management, Analytical Method..., Instrument Validation, SOP

Education
Southern Illinois University, Edwardsville   1988 — 1991
MS, Microbiology

Illinois College   1983 — 1986
Bachelor's degree, Biology, General

Matthew Kehrer Matthew Kehrer Greater Boston Area Details
Matthew Kehrer's Commissioning Agents, Inc Experience November 2011 - January 2012
Job Superintendent at Architectural Environments, Inc.
Industry Construction
Experience
Architectural Environments, Inc.   September 2015 - Present
R.H. White Construction   April 2014 - September 2015
Borrego Solar  July 2013 - April 2014
A/Z Corporation  January 2012 - July 2013
Commissioning Agents, Inc   November 2011 - January 2012
M. A. Mortenson Company   April 2011 - November 2011
M. A. Mortenson Company   May 2010 - August 2010
P&H Construction LLC   May 2007 - August 2010

Skills
Construction, Change Orders, Construction Management, Inspection, Sage Timberline Office, Primavera P6, Document Management, Process Scheduler, Electricians, Project Management, Maximo, Risk Management, Procurement, Project Planning, Engineering, Submittals, Civil Engineering, Adobe Acrobat, SmartSearch, Expedition, Concrete, Excavation, Value Engineering, Rigging, Subcontractor..., Surveying

Education
Southern New Hampshire University   2013 — 2016
Master of Business Administration (M.B.A.), Quantitative Analysis

Northern Michigan University   2007 — 2011
B.S., Construction Managment

David Salanty David Salanty Titusville, Florida Details
David Salanty's Commissioning Agents, Inc Experience July 2013 - February 2014
Job Facility Operations Manager at Sodexo
Industry Hospital & Health Care
Experience
Sodexo  February 2014 - Present
Commissioning Agents, Inc   July 2013 - February 2014
US Navy  August 2011 - August 2013
U. S. Navy   April 2007 - August 2011
Navy  December 2005 - June 2008
USS Carl Vinson (CVN 70)   February 2003 - November 2005
Naval Nuclear Power Training Command  2001 - 2003
USS Harry S. Truman (CVN 75)   1996 - 2001
USS South Carolina (CGN 37)   1992 - 1995

Skills
Nuclear, Maintenance Management, Reactor, Preventive Maintenance, Navy, Quality Assurance, Security Clearance, Military Experience, Military, Engineering, DoD, Nuclear Engineering, Military Operations, Maintenance & Repair, Supervisory Skills, Process Improvement, Testing, Defense, Engineering Management, Command, Plant Operations, Training, Operational Planning, Systems Engineering, Factory, Root Cause Analysis, Electrical Safety, Emergency Management, Steam, National Security, Military Training, Commissioning, Planned Preventative..., Power Generation, Inspection, Personnel Supervision, Power Plants, Calibration, Force Protection

Education
American Public University System   2007 — 2012
BA, Emergency and Disaster Management

Kristin Appelhans Kristin Appelhans Greater Boston Area Details
Kristin Appelhans's Commissioning Agents, Inc Experience June 2012 - Present
Job Validation Engineer at Commissioning Agents, Inc
Industry Chemicals
Experience
Commissioning Agents, Inc   June 2012 - Present
Tolmar Inc.  May 2011 - August 2011
Colorado State University  August 2009 - June 2011
City and County of Broomfield  May 2007 - January 2011

Education
Colorado State University   2008 — 2012
Bachelor of Science, Chemical and Biological Engineering; cum laude distinction

University of Queensland Brisbane   2010 — 2010

Tucker Palmer Tucker Palmer Fort Collins, Colorado Area Details
Tucker Palmer's Commissioning Agents, Inc Experience October 2012 - Present
Job Validation Engineer at Commissioning Agents, Inc
Industry Biotechnology
Experience
Commissioning Agents, Inc   October 2012 - Present
Advance Microlabs LLC   November 2006 - October 2012
Budweiser Event Center  November 2006 - October 2012
Colorado State University  August 2010 - May 2012
Palmer Stage Services   January 2003 - January 2011
Advanced Microlabs LLC   January 2008 - August 2010
Advanced Microlabs LLC   November 2006 - January 2008

Skills
Materials Science, Biomedical Engineering, Medical Devices, Fluorescence, Surface Chemistry, Validation, R, Chemistry, Cell Culture, Bioengineering, Analytical Chemistry, Labview, Lifesciences, Matlab, Gel Electrophoresis, Protein Purification, Mechanical Engineering, Electronics, Organic Synthesis, Biotechnology, PCR, GMP, Research, Statistics, Biomechanics, Mechanical Testing, Microscopy, Metal Fabrication, Biomaterials, Fluorescence Microscopy, Microbiology, Tissue Engineering, Data Analysis, Biophysics, Biochemistry, Technical Writing, Mathematica, Solidworks, Laboratory, Experimentation, Polymers

Education
Colorado State University   2010 — 2012
M.E., Biomedical Engineering

Colorado State University   2005 — 2009
B.S., Biochemistry, Chemistry, Molecular Biology

Ian Sobotka Ian Sobotka Mountain View, California Details
Ian Sobotka's Commissioning Agents, Inc Experience June 2014 - December 2014
Job Validation Contractor at YPEX Technology Resources, LLC
Industry Biotechnology
Experience
YPEX Technology Resources, LLC   January 2015 - Present
Commissioning Agents, Inc   June 2014 - December 2014
Progenitor Cell Therapy  October 2013 - May 2014
Progenitor Cell Therapy  June 2012 - October 2013
Georgetown University  June 2010 - May 2012

Skills
Validation, GMP, Aseptic Technique, Biotechnology, Aseptic Processing, SOP, Pharmaceutical Industry, Laboratory Skills, Process Improvement, Computer System..., Life Sciences, Cleaning Validation, Cell Culture, Laboratory, Laboratory Equipment, Report Writing, Logistics, Materials Management, Protocol Development, Neuroimaging, Proposal Writing, Microsoft Office

Education
Dickinson College   2006 — 2010
Bachelor of Science (BS), Neuroscience

Chase Helms, PE Chase Helms, PE Raleigh-Durham, North Carolina Area Details
Chase Helms, PE's Commissioning Agents, Inc Experience August 2007 - Present
Job Staff Engineer at Grifols
Industry Pharmaceuticals
Experience
Grifols  August 2015 - Present
Commissioning Agents, Inc   August 2007 - Present
North Carolina State University  May 2005 - September 2005
North Carolina State University  May 2004 - September 2004

Skills
Biotech Commissioning &..., Emerson DeltaV control..., Process Validation, Regulatory Audit..., Control System testing..., Diaphragm Valves, Critical and Support..., Kaye Validation, Control System test..., Autoclaves, SOP Development, P&ID Walkdowns, Factory acceptance test..., Turnover Package Review, Process Engineering, Maximo Data Entry, MS Project, Trackwise, Commissioning, Inspection, Pharmaceutical Industry, V&V, Engineering, Sop, Quality System, SOP development, Quality Assurance, Biotechnology, FDA, GMP, Validation

Education
North Carolina State University   2005 — 2007
MS, Biological Engineering

North Carolina State University   2001 — 2005
BS, Biological Engineering w/ conc. Bioprocessing

Francis Roura, P.E. Francis Roura, P.E. United States Details
Francis Roura, P.E.'s Commissioning Agents, Inc Experience August 2011 - December 2012
Job Engineer at Gilbane Building Company
Industry Civil Engineering
Experience
Gilbane Building Company  December 2012 - Present
Colegio de Ingenieros y Agrimensores de Puerto Rico  2011 - 2014
Commissioning Agents, Inc   August 2011 - December 2012
Caribbean Project Management  January 2009 - July 2009
Tiendas La Gloria, Inc.   May 2007 - October 2008
PwC  August 2006 - April 2007

Skills
Primavera P6, MS Project, Construction Management, Microsoft Excel, Financial Accounting, Microsoft Office, AutoCAD Civil 3D, OSHA 30-Hour, Equipment Commissioning, Professional Engineer..., Cost Accounting, Budgets, Civil Engineering, NFPA 70E, PowerPoint, Construction, Concrete, Project Management

Education
University of Puerto Rico   2007 — 2011
Engineering, Civil

University Of Puerto Rico at Mayagüez   2002 — 2006
Business, Accounting, Finance

Gary Stettler Gary Stettler Port Republic, Virginia Details
Gary Stettler's Commissioning Agents, Inc Experience January 2011 - Present
Job Validation Specialist at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   January 2011 - Present
US Navy  April 1987 - September 2010

Skills
Validation, GMP, RCM, Maintenance Strategy..., Reliability Centered..., Equipment Qualification, FDA GMP, SOP development, Quality Assurance, Sop, Testing, FDA, Troubleshooting, Inspection, Commissioning, Quality System, Process Simulation, Software Documentation, Calibration

Education
Southern Illinois University, Carbondale

Scott Mackley, CPIP Scott Mackley, CPIP Albany, New York Area Details
Scott Mackley, CPIP's Commissioning Agents, Inc Experience June 2000 - Present
Job CAI Project Manager at Shire Pharmaceuticals
Industry Biotechnology
Experience
Shire Pharmaceuticals  April 2014 - Present
Commissioning Agents, Inc   June 2000 - Present
Genzyme  March 2011 - March 2014
Biogen Idec  August 2010 - February 2011
Genzyme  March 2010 - August 2010
Biogen Idec  October 2009 - March 2010
Schering-Plough/Pharmadule   January 2008 - October 2009
Watson  2006 - 2008
Pfizer Pharmaceuticals  June 2000 - February 2005
Amgen  October 2001 - April 2002

Skills
Biotechnology, Commissioning, SOP, Preventive Maintenance, Technical Writing, cGMP, Validation, Documentation, Aseptic Processing, 21 CFR Part 11, HVAC, Pharmaceuticals, Troubleshooting, Root Cause Analysis, OSD, Critical Utilities, Nuclear, Metrology, GMP, GAMP, Sop, Change Control, Biopharmaceuticals, FDA, Technology Transfer, CAPA, GxP, GLP, Quality System, Software Documentation, LIMS, Process Simulation, Pharmaceutical Industry, Quality Auditing, Quality Assurance, Regulatory Affairs, ISO 13485, Process Engineering, Calibration, Design Control, Pharmaceutics, Regulatory Submissions, Quality Control, Quality Management, Cleaning Validation, Chromatography, Regulatory Requirements, Medical Devices, R&D

Education
The University of Texas at El Paso   1973 — 1991
Bachelor's Degree, Electrical and Electronics Engineering and Liberal Studies

Irvin High School   1969 — 1973
High School

Glen Doki Glen Doki Raleigh-Durham, North Carolina Area Details
Glen Doki's Commissioning Agents, Inc Experience February 2006 - December 2014
Job Validation and Quality Consultant
Industry Pharmaceuticals
Experience
SpecLine Consulting, Inc.   September 2015 - Present
Commissioning Agents, Inc CAI Consulting  January 2015 - August 2015
Commissioning Agents, Inc   February 2006 - December 2014
US Navy  December 2001 - February 2006

Skills
Validation, Automation, Biotechnology, Pharmaceutical..., Project Management, Technical Writing, V&V, Quality Assurance, GMP, Testing, Quality System, Pharmaceutical Industry, Computer System..., Software Documentation, Commissioning, Engineering, Nuclear, Change Control, FDA, GAMP, 21 CFR Part 11, Biopharmaceuticals, GxP, Technology Transfer, Sop, Process Simulation, CAPA, Quality Control, LIMS, Process Engineering, GLP, Root Cause Analysis, Calibration, Aseptic Processing, Quality Auditing, R&D, ISO 13485, SOP

Education
Duke University   1995 — 2001
MA, Nuclear/Particle Physics

University of Connecticut   1990 — 1995
BS, Physics

Guilford High School

Robert Chew Robert Chew Indianapolis, Indiana Area Details
Robert Chew's Commissioning Agents, Inc Experience 2008 - Present
Job President at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   2008 - Present
Commissioning Agents, Inc   1996 - 2008
Performance Validation  1990 - 1996
Sonalysts  1988 - 1990
Teton Adventures   1986 - 1988
United States Navy  1981 - 1986

Education
Case Western Reserve University   1978 — 1981
BS, Chemical Engineering

Geoff Swafford Geoff Swafford Raleigh-Durham, North Carolina Area Details
Geoff Swafford's Commissioning Agents, Inc Experience April 2009 - September 2011
Job Senior Product Strategist at Lonza
Industry Pharmaceuticals
Experience
Lonza  September 2011 - Present
Novartis Vaccines and Diagnostics  January 2010 - September 2011
Commissioning Agents, Inc   April 2009 - September 2011
Genentech  April 2009 - January 2010
Amylin Pharmaceuticals  May 2008 - April 2009
International Society of Pharmaceutical Engineering   2005 - 2009
Commissioning Agents, Inc   September 2001 - May 2008
Ablesoft Solutions, Inc.   September 2000 - September 2001

Skills
IT Professional, Software Development, Software Implementation, Software Quality..., Software Sales, Computer System..., Commissioning, Training & Development, Personnel Development, Change Management, FDA GMP, Validation, Testing, Software Industry, 21 CFR Part 11, Quality Assurance, GMP, Pharmaceutical Industry, CAPA, Process Engineering, Change Control, FDA, Software Documentation, SDLC, Process Improvement, Automation, ERP, LIMS, GxP, GAMP

Education
University of Phoenix   2008 — 2012
BS, Business Information Systems

ECPI University   1998 — 2000
AAS, Computer Information Systems

Some

Reza Tavana Reza Tavana San Francisco Bay Area Details
Reza Tavana's Commissioning Agents, Inc Experience August 2009 - Present
Job Validation Engineer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   August 2009 - Present
Santa Cruz Biotechnology  January 2007 - December 2008
Cal Poly Health and Counseling Services   May 2003 - June 2006

Skills
Biotechnology, Validation, Laboratory, Analytical Chemistry, Medical Devices, GMP, FDA, Quality System

Education
California Polytechnic State University-San Luis Obispo   2007 — 2008
M.S., Biomedical Engineering

California Polytechnic State University-San Luis Obispo   2001 — 2006
B.S., Biochemistry

Brett Myers Brett Myers Silex, Missouri Details
Brett Myers's Commissioning Agents, Inc Experience February 2012 - August 2015
Job Validation Specialist at Nesher Pharmaceuticals (USA) LLC
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   February 2012 - August 2015
Homeyer Precision Manufacturing   December 2011 - February 2012
Reckitt Benckiser  January 1981 - December 2011

Skills
GMP, Change Control, Validation, FDA, Quality System, Medical Devices, SPC, CAPA, V&V, 21 CFR Part 11, Pharmaceutical Industry, Quality Auditing, Computer System..., GxP, GLP, Sop, Quality Assurance, ISO 13485, Quality Management, ISO, Regulatory Affairs, Quality Control, Six Sigma, R&D, Iso 9000, Root Cause Analysis, Biopharmaceuticals, Lean Manufacturing, Continuous Improvement, Manufacturing Operations, Cleaning Validation, 5S, Process Engineering, Contract Manufacturing, Cross-functional Team..., SMED, Manufacturing..., SOP, Manufacturing

Education
American InterContinental University   2005 — 2007
Bachelor's degree, Business Administration, Management and Operations

University of Phoenix   2004 — 2005

Kristen Vanderbeek Kristen Vanderbeek San Francisco Bay Area Details
Kristen Vanderbeek's Commissioning Agents, Inc Experience November 2012 - October 2013
Job Consultant
Industry Biotechnology
Experience
Intarcia Therapeutics, Inc.   March 2015 - May 2015
Genentech  December 2013 - February 2015
Commissioning Agents, Inc   November 2012 - October 2013
Allergan  February 2010 - November 2012
Allergan  September 2005 - February 2010
Cognate Therapeutics   June 2002 - July 2005
UCSF  July 2002 - January 2003
Geron  January 2002 - June 2002
ChemRx  November 2001 - December 2001
Genentech  July 2001 - October 2001

Skills
Aseptic Processing, Adult Stem Cells, GLP, Process Simulation, Sop, Six Sigma, Protein Purification, Purification, LIMS, ELISA, Biopharmaceuticals, GMP, FDA, Validation, Microbiology, Cell Culture, Fermentation, SOPs, Tissue Culture, Buffer and Media..., Aseptic processing, Protein purification, Aseptic Fill, ELISAs, FACS-staining, Primary cell lines, High-throughput cell..., Embryotic stem cells, Adult stem cells, CAPA, OSHA 10-Hour Certified

Education
University of California Santa Cruz   2007 — 2009
Certificate in Clinical Trials, 3.8

University of California, Santa Cruz   2004 — 2006
Certificate in Biotechnology, 3.7

Humboldt State University   1996 — 2001
Biology, Biology, Chemistry & Computer Information Systems

Amy Lineberry, CPIP Amy Lineberry, CPIP Raleigh-Durham, North Carolina Area Details
Amy Lineberry, CPIP's Commissioning Agents, Inc Experience August 2005 - June 2010
Job Project Manager for Pharmaceutical Industry
Industry Pharmaceuticals
Experience
Mangan Inc.  April 2013 - Present
SpecLine Consulting, Inc.   June 2010 - March 2013
Commissioning Agents, Inc   August 2005 - June 2010
Wyeth Biotech  May 2005 - August 2005
CVS/Pharmacy  February 2001 - August 2005

Skills
Commissioning, Validation, ISO 9001, Resume Writing, Biotechnology, Engineering, ISO, Pharmaceutics, 21 CFR Part 11, Manufacturing, GMP, Change Control, V&V, CAPA, Sop, Biopharmaceuticals, Cleaning Validation, GLP, Design of Experiments, Technology Transfer, FDA, Quality Management, Iso 9000, GxP, LIMS, Quality System, Aseptic Processing, Pharmaceutical Industry, Chromatography, Computer System..., SOP

Education
Stat-A-Matrix   2011 — 2011
Certificate, ISO 9001 Lead Auditor Training

ISPE   2010 — 2010
Risk MaPP Training Conference

IBC USA   2007 — 2007
Certificate, Biopharmaceuticals

ISPE   2006 — 2006
Certificates, Pharmaceutical Training

Campbell University   2001 — 2005
Bachelors, Pharmaceutical Sciences

Nathan Temple, PE, PMP Nathan Temple, PE, PMP San Francisco Bay Area Details
Nathan Temple, PE, PMP's Commissioning Agents, Inc Experience May 2011 - Present
Job Director of Operations, Pacific Region
Industry Biotechnology
Experience
Commissioning Agents, Inc   May 2011 - Present
Commissioning Agents, Inc   January 2010 - March 2012
Commissioning Agents, Inc   January 2008 - April 2011
Commissioning Agents, Inc   July 2008 - December 2009
Commissioning Agents, Inc   April 2005 - March 2009
US Navy  1996 - 2003

Skills
Validation, Quality Assurance, Change Control, Computer System..., Project Management, Engineering, Commissioning, Cross-functional Team..., GMP, Manufacturing, Process Simulation, Testing, GAMP, Biotechnology, Continuous Improvement, Quality System, Nuclear, Software Documentation, Automation, PLC, Biopharmaceuticals, Process Engineering, Quality Control, Quality Auditing, MES, Miller-Heiman Strategic..., Project Planning, Certified Project..., Operations Management, Contract Management, Proposal Writing, Proposal Generation, Conducting Interviews, CSV, Risk Management, Risk Assessment, VMware Infrastructure, Cleaning Validation, Process Verification, Validation Master Plans, Independent..., S95, 21 CFR Part 11, S88, Root Cause Analysis, Project Execution, Contract Review, Risk Based Testing

Education
Stanford Graduate School of Business
Executive Program for Growing Companies

Old Dominion University   2002 — 2003
MS, Engineering Management

Rensselaer Polytechnic Institute   1992 — 1996
BS, Nuclear Engineering

Continuing Education

Presentations

Jay Congdon, CEM, CBCPM, CMVP, CEA Jay Congdon, CEM, CBCPM, CMVP, CEA New London/Norwich, Connecticut Area Details
Jay Congdon, CEM, CBCPM, CMVP, CEA's Commissioning Agents, Inc Experience July 2003 - Present
Job Engineering Consultant, Energy Engineering Services, Regulated Industry Commissioning/Validation/QA Services
Industry Mechanical or Industrial Engineering
Experience
Biogen Idec  October 2010 - Present
BioMed Realty Trust  October 2010 - Present
Commissioning Agents, Inc   July 2003 - Present
Shire HGT  November 2008 - March 2010
Genzyme  2010 - 2010
OPK Biotech, LLC  2010 - 2010
Commissioning Agents, Inc   2003 - 2009
Pfizer  February 2008 - November 2008
Progenics Pharmaceuticals  2006 - 2008
Amgen  2003 - 2007

Skills
Validation, Commissioning, Engineering, SOP, Biotechnology, Technical Writing, Quality Assurance, Troubleshooting, Documentation, Process Engineering, Change Management, Problem Solving, Process Improvement, Continuous Improvement, GMP, Testing, Quality Systems, Technical Training, HVAC, cGMP, Project Planning, Scheduling, Measurement and..., Energy Engineering, Sop, Nuclear, Certified Building..., Certified Energy Manager, Energy Audits, Engineering Change..., Change Control, Training, Quality System, Preventive Maintenance, Computer System..., Project Management, Facilities Management, GAMP, Process Simulation, GxP, FDA, 21 CFR Part 11, Root Cause Analysis, Energy, CAPA, R&D, Steam, Automation, Pharmaceutical Industry, Maintenance Management

Education
University of the State of New York   1989 — 1990
BS

North Central College   1978 — 1981
Worked towards BS, Mathematics, Psychology, Computers, Business, Sociology, English, History, Acting, Radio

Naperville North High School   1976 — 1978

Bayshore High School   1974 — 1976

Michelle Wrenn Michelle Wrenn Raleigh-Durham, North Carolina Area Details
Michelle Wrenn's Commissioning Agents, Inc Experience November 2005 - December 2007
Job Compliance Specialist at Johnson Controls Inc
Industry Pharmaceuticals
Experience
Johnson Controls (GlaxoSmithKline Account)   January 2008 - Present
Commissioning Agents Inc  November 2005 - December 2007
Biogenidec, Inc   January 2003 - November 2005
Biogen, Inc  January 2001 - January 2003
Biogen, Inc  January 2000 - January 2001
Biogen, Inc  September 1998 - January 2000

Skills
CAPA, Validation, Compliance, Technical Writing, Deviation Investigation, Corrective Action, Preventive Actions, Deviations, Change Control, V&V, Aseptic Processing, Purification, GMP, GxP, 21 CFR Part 11, Trackwise, Software Documentation, Corrective Actions, TrackWise, SOP, Pharmaceutical Industry, FDA, Biopharmaceuticals, Biotechnology, Quality System

Education
Campbell University   2005 — 2007
B.S. Applied Science

Alamance Community College   1995 — 1998
A.A.S. Degree in Biotechnology, Biotechnology

Eric Blanchone Eric Blanchone Raleigh-Durham, North Carolina Area Details
Eric Blanchone's Commissioning Agents, Inc Experience 2004 - 2006
Job Senior Specialist, Quality Assurance at Merck
Industry Pharmaceuticals
Experience
Merck  July 2014 - Present
Merck  January 2013 - July 2014
Merck  July 2011 - January 2013
Ajinomoto AminoScience LLC  2009 - 2011
Ajinomoto AminoScience LLC  2008 - 2011
Ajinomoto AminoScience LLC  August 2006 - July 2008
Commissioning Agents, Inc   2004 - 2006

Skills
Deviation Management, Root Cause Analysis, SAP ERP, Human Error Prevention, Autoclave, Washers, Reliability, Quality management, Engineering Mentor, Technical Writing, Validation Management, Quality Control..., Quality Engineering, Facility Start-up, FDA, GMP, GLP, Validation, CAPA, Quality Management, Change Control, Quality Control, Quality Assurance, 21 CFR Part 11, Biotechnology

Education
North Carolina State University   1999 — 2004
BS, Chemical Engineering

John Stolarik John Stolarik Raleigh-Durham, North Carolina Area Details
John Stolarik's Commissioning Agents, Inc Experience October 2004 - Present
Job Project Manager at CAI
Industry Biotechnology
Experience
Novartis  2009 - Present
Novartis USFCC   2009 - Present
Commissioning Agents, Inc   October 2004 - Present
Wyeth Pharmaceuticals  2004 - 2007
United States Navy  1984 - 2004
US Navy  1984 - 2004

Skills
Validation, GMP, Quality Assurance, Sop, FDA, Process Engineering, Troubleshooting, V&V, Commissioning, Software Documentation, Technical Writing, Calibration, Computer System..., Biotechnology, Root Cause Analysis, Preventive Maintenance, Testing, Change Control, Quality System, Process Improvement, Steam, Maintenance Management, GxP, Manufacturing, Biopharmaceuticals, HVAC, 21 CFR Part 11, GAMP, CAPA, Aseptic Processing, Process Control, SOP

Education
Albertus Magnus College   2001 — 2003
BS, Business Administration and Management, General

David Truex David Truex Cape Coral, Florida Details
David Truex's Commissioning Agents, Inc Experience November 2012 - July 2013
Job Project Manager at Commissioning Agents.
Industry Pharmaceuticals
Experience
Commissioning Agents.   August 2013 - Present
Commissioning Agents, Inc   November 2012 - July 2013
Commissioning Agents, Inc   April 2009 - October 2012
Commissioning Agents   September 2006 - April 2009
Commissioning Agents, In   June 2005 - March 2006
US Navy  1981 - 2005

Skills
Validation, Commissioning, Project Management, Nuclear, Quality Assurance, GMP, Engineering, Sop, Process Improvement, Change Control, Quality System, Navy, Security Clearance, Process Engineering, Program Management, Change Management, Project Planning, Technical Writing, FDA

Education
Thomas Edison State College   2002 — 2005
Nuclear Technology

Patrick Wagner Patrick Wagner Indianapolis, Indiana Details
Patrick Wagner's Commissioning Agents, Inc Experience June 2011 - June 2013
Job Project Manager
Industry Pharmaceuticals
Experience
BCforward  August 2014 - Present
Mindlance  September 2013 - July 2014
Commissioning Agents, Inc   June 2011 - June 2013
Indiana University School of Medicine  August 2010 - February 2011
DePauw University  December 2008 - May 2009

Education
DePauw University   2006 — 2010
BA, Biology, Spanish

Indiana University-Purdue University at Indianapolis   2010 — 2011
MS, Biology

Suzanne Mecalo, CPIP Suzanne Mecalo, CPIP Greater Denver Area Details
Suzanne Mecalo, CPIP's Commissioning Agents, Inc Experience August 2004 - Present
Job Project Manager at Commissioning Agents, Inc and Pharmaceuticals Consultant
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   August 2004 - Present
FeRx, Incorporated  November 1998 - May 2004
SmithKline Beecham  January 1995 - April 1997
Pevely Dairy   June 1992 - January 1995

Skills
Pharmaceutical Industry, Microbiology, Calibration, Pharmaceutics, GMP, Sop, Biotechnology, FDA, CAPA, Medical Devices, Quality Assurance, Quality System, Validation, Change Control, 21 CFR Part 11, Commissioning, Laboratory, Manufacturing, Technology Transfer, V&V, SOP

Education
McKendree College   1988 — 1992
BA, Biology

Marty Racht Marty Racht Portland, Oregon Area Details
Marty Racht's Commissioning Agents, Inc Experience September 2000 - February 2011
Job Owner of Racht Solid Validation Professionals, LLC
Industry Pharmaceuticals
Experience
Racht Solid Validation Professionals   July 2014 - Present
Genentech  March 2011 - June 2014
CAI  2001 - February 2011
Commissioning Agents, Inc   September 2000 - February 2011
US Navy  1979 - 1999
Nuclear Power Training Unit Ballston Spa, NY   1994 - 1997

Skills
Project Planning, Quality Assurance, Commissioning, Validation

Education
New School University   1996 — 1999
Bachelor's degree, Human Resources Management and Services

Western Wayne High School   1974 — 1978

Sam Charron Sam Charron Greater Boston Area Details
Sam Charron's Commissioning Agents, Inc Experience November 2010 - April 2011
Job Manufacturing Manager at Histogenics
Industry Biotechnology
Experience
Histogenics  May 2013 - Present
Histogenics  April 2011 - April 2013
Commissioning Agents, Inc   November 2010 - April 2011
Histogenics  December 2009 - September 2010
Shire HGT  April 2005 - November 2009
Shire HGT  June 2001 - April 2005
TKT  2001 - 2004

Skills
GMP, Validation, SOP, Biotechnology, Cell Culture, cGMP, Documentation, Manufacturing, Aseptic Processing, SAP, Change Control, CAPA, Sop, Software Documentation, LIMS, Technology Transfer, Quality System, GLP, Medical Devices, Aseptic Technique, Biopharmaceuticals, Pharmaceutical Industry, Trackwise, 21 CFR Part 11, FDA

Education
Babson College - Franklin W. Olin Graduate School of Business   2014 — 2019
Master of Business Administration (MBA)

University of Massachusetts Dartmouth   1997 — 2001
BS, Biology, General

Ekaterina Karaslavova Ekaterina Karaslavova San Jose, California Details
Ekaterina Karaslavova's Commissioning Agents, Inc Experience November 2007 - August 2008
Job Senior Process Engineer at ProteinSimple
Industry Biotechnology
Experience
ProteinSimple  July 2015 - Present
BD Biosciences, San Jose CA   May 2013 - July 2015
Shocking Technologies  July 2010 - February 2013
Alexza Pharmaceuticals, Inc.   August 2008 - September 2010
Commissioning Agents, Inc   November 2007 - August 2008
ALZA / Centocor PD   July 2006 - November 2007
ALZA Corporation  2001 - 2006
ALZA  2000 - 2001
LifeScan  1998 - 2000

Skills
Validation, Manufacturing, R&D, CAPA, GMP, Technology Transfer, Design of Experiments, Biotechnology, Change Control, Medical Devices, Sop, Pharmaceutical Industry, Process Simulation, Biopharmaceuticals, ISO 13485, 21 CFR Part 11, Drug Delivery, Processes Development, Chemical Engineering, Formulation, Process Engineering, SOP

Education
Himiko-tehnologièen i metalurgièen universitet
Master's degree, Chemical Engineering

Greg Mayfield Greg Mayfield Raleigh-Durham, North Carolina Area Details
Greg Mayfield's Commissioning Agents, Inc Experience January 2011 - September 2012
Job Senior Validation Specialist at Compliance Technology Group
Industry Pharmaceuticals
Experience
Compliance Technology Group  June 2014 - Present
Intergrated Commissioning & Qualification Consultants   September 2012 - Present
Intergrated Commissioning & Qualification Consultants   January 2014 - May 2014
Commissioning Agents, Inc   January 2011 - September 2012
Biogen Idec  June 2004 - January 2011
BIOGEN IDEC, Cambridge, MA/ Research Triangle Park, NC   2004 - 2007
DIOSYNTH, RTP, NC   2001 - 2004
Sharon Harris Nuclear power plant   November 2000 - December 2001
United States Navy  1997 - November 2000
United States Navy  1994 - 1997

Skills
Validation, Supervising, Continuous Improvement, Trackwise, GMP, Sop, Biotechnology, Chromatography, Pharmaceutical Industry, Cell Culture, Manufacturing, Lean Manufacturing, Process Improvement, Medical Devices, Aseptic Technique, Aseptic Processing, Biopharmaceuticals, CAPA, Engineering, FDA, Cleaning Validation, SOP, TrackWise

Education
University of Phoenix   2008 — 2010
BS, Management

Capella University   2006 — 2008
Business Administration and Management, General

Erin Jarrett Erin Jarrett Indianapolis, Indiana Area Details
Erin Jarrett's Commissioning Agents, Inc Experience project managercommissioning agents1996 - 2009
Job Business Manager, North America at Commissioning Agents Inc
Industry Pharmaceuticals
Experience
Commissioning Agents Inc  project managercommissioning agents1996 - 2009
commissioning agents   1996 - 2008

Skills
Validation

Education
Indiana University-Purdue University at Indianapolis   1992 — 1997

Matthew Ferrier Matthew Ferrier Mystic, Connecticut Details
Matthew Ferrier's Commissioning Agents, Inc Experience May 2006 - November 2007
Job Principal Analyst at Sonalysts, Inc.
Industry Information Technology and Services
Experience
Sonalysts, Inc.   March 2014 - Present
US Navy  October 2011 - September 2013
US Navy  May 2011 - September 2011
Tastings Wine Bar   October 2010 - April 2011
US Navy  October 2009 - September 2010
APC-MGE  December 2007 - October 2009
Commissioning Agents, Inc   May 2006 - November 2007
Commissioning Agents, Inc   May 2003 - May 2006
Information Outpost, LLC   January 1999 - April 2003
Applied Materials  August 1995 - December 1998

Education
University of Connecticut   2001 — 2003
MS, Electrical Engineering

Santa Clara University   1996 — 1998
MBA

United States Naval Academy   1984 — 1988
BS, Systems Engineering

Jesse Dill Jesse Dill Bloomington, Indiana Area Details
Jesse Dill's Commissioning Agents, Inc Experience September 2009 - November 2012
Job Senior Engineer at Amylin Pharmaceuticals
Industry Biotechnology
Experience
Amylin Pharmaceuticals  December 2012 - Present
Commissioning Agents, Inc   September 2009 - November 2012
Cook Pharmica  2007 - 2009
Amgen  2003 - 2007

Skills
CAPA, Change Control, Validation, FDA, GMP, Aseptic Processing, Manufacturing, V&V, Technology Transfer, Computer System..., Biopharmaceuticals, Sop, SOP

Education
Penn State University   1998 — 2002
BS, Chemical Engineering

Eric Owen Eric Owen Wichita, Kansas Area Details
Eric Owen's Commissioning Agents, Inc Experience 2004 - 2006
Job Principal Process Engineer, MS&T, at Hospira
Industry Pharmaceuticals
Experience
Hospira  December 2013 - Present
Hospira  July 2012 - Present
Amgen  January 2011 - June 2012
Amgen  June 2006 - December 2010
Commissioning Agents, Inc   2004 - 2006
US Navy  January 1998 - January 2004

Skills
Biotechnology, GMP, Process Engineering, Validation, FDA, Trackwise, Manufacturing, Sop, Automation, Supply Chain Security, Supplier Quality..., Risk Management, Change Control, Quality Assurance, CAPA, Root Cause Analysis, Aseptic Processing, Quality Control, Cross-functional Team..., Biopharmaceuticals, Pharmaceutical Industry, Quality System, Computer System..., Commissioning, Process Simulation, Engineering, Technology Transfer, 21 CFR Part 11, GAMP, Process Improvement, Cleaning Validation, GxP

Education
Colorado State University   2010 — 2012
MBA

Thomas Edison State College
Nuclear Engineering Technology

Brian Kelenc Brian Kelenc Greater Denver Area Details
Brian Kelenc's Commissioning Agents, Inc Experience September 2011 - January 2012
Job Validation Engineer at Sandoz
Industry Biotechnology
Experience
Sandoz  January 2012 - Present
Commissioning Agents, Inc   September 2011 - January 2012
Amgen  December 2005 - August 2011
Yaegle Validation, Inc./SAVIS, Inc.   June 2001 - December 2005

Skills
Validation, GMP, FDA, Change Control, 21 CFR Part 11, CAPA, Biotechnology, SOP, Biopharmaceuticals, Pharmaceutical Industry

Education
Northern Illinois University   1997 — 2001
B.S., Electrical Engineering

Daniel Ramsey Daniel Ramsey Greater Boston Area Details
Daniel Ramsey's Commissioning Agents, Inc Experience February 2013 - April 2015
Job Associate Director, Maintenance and Engineering at Novartis Institutes for BioMedical Research
Industry Biotechnology
Experience
Novartis Institutes for BioMedical Research  April 2015 - Present
Commissioning Agents, Inc   February 2013 - April 2015
Commissioning Agents, Inc   February 2011 - February 2013
Biogen Idec  2006 - 2011
AMEC  June 2007 - September 2008
ARAMARK  June 2006 - June 2007

Skills
Validation, GMP, Commissioning, Continuous Improvement, Project Management, HVAC, Management, Facilities Management, Construction, Energy, Budgets, Preventive Maintenance, Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, FDA, Quality System, Change Control, Sop, Quality Assurance

Education
Massachusetts Maritime Academy   2006 — 2008
Masters Degree, Faciltiy Management

Massachusetts Maritime Academy   1998 — 2004
BS, Engineering

Hamilton Wenham Regional High School   1994 — 1998

Patrick Sabourin Patrick Sabourin Raleigh-Durham, North Carolina Area Details
Patrick Sabourin's Commissioning Agents, Inc Experience 2000 - 2006
Job Director Quality Operations, at Novartis Vaccines
Industry Pharmaceuticals
Experience
Novartis Vaccines and Diagnostics  December 2007 - Present
Clarkston Consulting  2006 - 2007
Commissioning Agents, Inc   2000 - 2006
Sanofi Recherche   March 1998 - May 2000
Sanofi Winthrop, UK   September 1995 - September 1997
Sanofi Winthrop, USA   June 1994 - September 1995
Sanofi Winthrop USA   June 1992 - June 1994
Sanofi Winthrop France   February 1989 - June 1992

Skills
Validation, GMP, Compliance, Quality Assurance, Auditing, Manufacturing, Biotechnology, FDA, Quality Auditing, SOP, cGMP, Process Validation, 21 CFR Part 11, Quality Systems, Testing, Risk Management, Pharmaceuticals, Biopharmaceuticals, QC, Vaccines, GxP, Change Control, CAPA, Aseptic Processing, Quality Management, Cleaning Validation, Documentation, Change Management, Document Management

Education
Conservatoire National des Arts et Métiers   1980 — 1985

Rob DeCoste Rob DeCoste Greater Boston Area Details
Rob DeCoste's Commissioning Agents, Inc Experience August 2009 - May 2011
Job Process Engineer at Biogen Idec
Industry Pharmaceuticals
Experience
Biogen Idec  May 2011 - Present
Commissioning Agents, Inc   August 2009 - May 2011
Bard, Rao + Athanas Consulting Engineers, LLC   March 2008 - August 2009
Gurney Engineering   2002 - 2006

Skills
Commissioning, Biotechnology, Sop, Validation, FDA, Change Control, GMP, Quality System, Process Simulation, CAPA, Technology Transfer, Nursing Homes

Education
Massachusetts Maritime Academy   2006 — 2008
Master's, Facilities Managment

Massachusetts Maritime Academy   1998 — 2002
Bachelor's, Facilities and Environmental Engineering

Patti Parekh Patti Parekh Edison, New Jersey Details
Patti Parekh's Commissioning Agents, Inc Experience April 2014 - October 2014
Job Technical Services Manager
Industry Biotechnology
Experience
Commissioning Agents, Inc CAI Consulting  October 2014 - Present
Commissioning Agents, Inc CAI Consulting  October 2014 - Present
Commissioning Agents, Inc CAI Consulting  August 2014 - Present
Commissioning Agents, Inc   April 2014 - October 2014
Commissioning Agents, Inc   October 2013 - April 2014
Commissioning Agents, Inc   December 2013 - January 2014
Commissioning Agents, Inc   September 2013 - December 2013
Commissioning Agents, Inc   July 2011 - August 2013
Commissioning Agents, Inc   March 2010 - June 2011
Commissioning Agents, Inc   August 2008 - December 2009

Skills
Biotechnology, Technology Transfer, Root Cause Analysis, Risk Management, Staff Training/Mentoring, Viral Clearance, DMAIC, Design of Experiments, Protocol Development, Protein Purification, Manufacturing..., Change Controls, Biopharmaceutical/Pharma..., electronic Common..., JUMP software, Emerson DeltaV, GE UNICORN and..., Cleaning Validation, Chromatography, Filtration, Vaccines, HPLC, Purification, cGMP manufacturing, Validation, Biopharmaceuticals, Regulatory Submissions, Cell Culture, GxP, Technical Writing, SDS-PAGE, Downstream Processing, Drug Discovery, Quality by Design, Trackwise, Quality Assurance, Quality Control, Quality Auditing, Process Simulation, Manufacturing, Program Management, FDA Processes &..., FDA, Change Control, CAPA, GMP, Pharmaceutical Industry, Process Engineering, SOP, Life Sciences

Education
Columbia University in the City of New York   2005 — 2008
Master of Science, Chemical Engineering

Rutgers University   1998 — 2003
Bachelor of Science (B.S.), Biochemical Engineering

Rutgers University   1998 — 2003
Bachelor of Arts (B.A.), Economics

Michael Lemery Michael Lemery Glens Falls, New York Area Details
Michael Lemery's Commissioning Agents, Inc Experience 2006 - 2007
Job Off Hull Shift Supervisor at Bechtel Marine Propulsion Corporation
Industry Oil & Energy
Experience
Bechtel Marine Propulsion Corporation  March 2011 - Present
Granite Services  August 2009 - May 2011
Granite Services  February 2007 - July 2009
Granite Services  March 2007 - July 2007
Commissioning agents, Inc   2006 - 2007
U.S. Navy   1985 - 2006

Skills
Nuclear, Nuclear Engineering, Power Generation

Education
The New School   2002 — 2005

Eric Alfonso Eric Alfonso Puerto Rico area Details
Eric Alfonso's Commissioning Agents, Inc Experience June 2014 - Present
Job Validation and Compliance Consultant
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   June 2014 - Present
Amgen Manufacturing Limited  September 2013 - February 2014
Abbot Medical Optics   June 2013 - September 2013
Bristol-Myers Squibb  January 2011 - March 2013
Bristol-Myers Squibb  May 2010 - December 2010
Bristol-Myers Squibb  June 2009 - May 2010
Bristol-Myers Squibb  2006 - January 2009
Amgen Pharmaceuticals  September 2005 - January 2006
Ivax Pharmaceuticals  April 2005 - September 2005
Elli Lilly, Inc.   September 2004 - March 2005

Skills
GMP, Validation, 21 CFR Part 11, Sop, Quality Assurance, Biotechnology, Computer System..., Change Control, Aseptic Processing, CAPA, GAMP, GxP, Pharmaceutical Industry, FDA, Manufacturing, Biopharmaceuticals, Quality System, Pharmaceutical Packaging, SOP

Education
Inter-American University of Puerto Rico-Metropolitan Campus   1990 — 1995
Master's, MBA

US ARMY Intern Training Center   1982 — 1983
N/A, Quality and Reliability Engineering

University of Puerto Rico - Mayaguez Campus   1977 — 1982
Bachellor's, Chemical Engineering

Alvin Vazquez Alvin Vazquez Greenwood, Indiana Details
Alvin Vazquez's Commissioning Agents, Inc Experience August 2012 - November 2014
Job Validation Engineer
Industry Pharmaceuticals
Experience
Amgen  January 2014 - November 2014
Commissioning Agents, Inc   August 2012 - November 2014
Pfizer  October 2013 - October 2013
Terumo Cardiovascular Systems  August 2013 - October 2013
Sigma Tao Pharmasource   July 2013 - August 2013
CSL Behring  March 2013 - July 2013
Bristol-Myers Squibb  2012 - 2013
home  November 2010 - August 2012
retired ( just taking a break )   November 2010 - 2011
Eli Lilly & Co.   January 1978 - November 2010

Skills
GMP, Validation, CAPA, FDA, Pharmaceutical Industry, V&V, Quality System, Root Cause Analysis, Six Sigma, Manufacturing, Medical Devices, Sop, Lean Manufacturing, Technology Transfer, Change Control, Computer System..., Process Engineering, Engineering, Commissioning, Process Simulation, ISO 13485, Instrumentation, 21 CFR Part 11, Quality Assurance, Aseptic Processing, Quality Control, GxP, GLP, Quality Auditing, Design of Experiments, R&D, GAMP, Design Control, Biotechnology, Testing, Pharmaceutics, Calibration, LIMS, Cleaning Validation, Biopharmaceuticals, FMEA, FDA GMP, TrackWise, Equipment Qualification, Analytical Chemistry, HPLC, Chromatography, Quality Management, Regulatory Affairs, Continuous Improvement

Education
Indiana University-Purdue University at Indianapolis   1995 — 1999

Tab Bronson Tab Bronson Greater Seattle Area Details
Tab Bronson's Commissioning Agents, Inc Experience April 2002 - June 2003
Job Retired
Industry Biotechnology
Experience
Bayer HealthCare  2005 - April 2012
Amgen  June 2003 - June 2005
Commissioning Agents, Inc   April 2002 - June 2003
Monsanto  1997 - February 2002

Skills
FDA, Validation

Education
Northern Illinois University
BS

Webster University
MS, Management

Jenny Brown-Chin Jenny Brown-Chin Raleigh-Durham, North Carolina Area Details
Jenny Brown-Chin's Commissioning Agents, Inc Experience July 2002 - July 2006
Job Graduate Student
Industry Health, Wellness and Fitness
Experience
Biogen Idec  July 2006 - January 2008
Commissioning Agents, Inc   July 2002 - July 2006

Education
Meredith College   2008 — 2010
Masters of Science, Nutrition

North Carolina State University   1998 — 2002
BS, Chemical Engineering

Jesse Mckibben Jesse Mckibben Greater Omaha Area Details
Jesse Mckibben's Commissioning Agents, Inc Experience January 2006 - July 2013
Job Senior Project Manager at Commissioning Agents, Inc | CAI Consulting
Industry Management Consulting
Experience
Commissioning Agents, Inc CAI Consulting  September 2015 - Present
Johnson Controls  July 2013 - June 2015
Commissioning Agents, Inc   January 2006 - July 2013
Wright Packaging, Inc.   February 2005 - September 2005
United States Navy  January 1984 - March 2005

Skills
Quality Assurance, Leadership, Nuclear, Computer System..., FDA, Change Control, Validation, CAPA, Sop, GMP, V&V, Root Cause Analysis, SOP, 21 CFR Part 11

Education
Thomas Edison State College   2004 — 2005
Bachelor of Science (BS), Applied Engineering Technology

Adam Foard Adam Foard Houston, Texas Area Details
Adam Foard's Commissioning Agents, Inc Experience June 2013 - May 2014
Job Electrical Engineer at Canrig Drilling Technology Ltd.
Industry Oil & Energy
Experience
Canrig Drilling Technology Ltd.  June 2014 - Present
Commissioning Agents, Inc   June 2013 - May 2014
GE Energy  November 2007 - May 2013
FPL  May 2007 - October 2007
U.S. Navy   June 1998 - April 2007

Skills
DCS, Nuclear Engineering, Automation, Gas Turbines, Electricians, Instrumentation, Control Systems Design, Engineering, Engineering Management, Electronic Control..., Process Control, SCADA, Power Plants, Power Generation, PLC, Steam Turbines, Nuclear, P&ID, Project Engineering, Energy, PLC Programming, Preventive Maintenance, Factory, Turbines, Commissioning, Nuclear Physics

Education
Rensselaer Polytechnic Institute   2004 — 2005
B. Sc.

Phil Pursifull Phil Pursifull Indianapolis, Indiana Area Details
Phil Pursifull's Commissioning Agents, Inc Experience January 1998 - Present
Job Chief Financial Officer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   January 1998 - Present

Skills
Pharmaceutical Industry, Biotechnology, Quality System, Cross-functional Team..., ESOP administration, Corporate Finance, Corporate Tax, Financial Audits, International Business, Labor Relations, Management Accounting

Education
University of California, Santa Barbara   1996 — 1998

Georgia Institute of Technology   1989 — 1994
BChE, Chemical Engineering

Stephanie Coates Stephanie Coates Raleigh-Durham, North Carolina Area Details
Stephanie Coates's Commissioning Agents, Inc Experience February 2008 - August 2013
Job Validation Engineer
Industry Pharmaceuticals
Experience
Grifols  October 2013 - Present
Commissioning Agents, Inc   February 2008 - August 2013
GlaxoSmithKline  2007 - 2008
Family Health International  2005 - 2007

Skills
Validation, GMP, Aseptic Processing, Sop, Quality System, FDA, Commissioning, Biotechnology, Critical Support..., Environmental Monitoring, Temperature Mapping, Cleaning Validation, Software Documentation, Engineering, Testing, Quality Control, 21 CFR Part 11, Biopharmaceuticals, Quality Assurance, GxP, GLP, SOP

Education
North Carolina State University   2015 — 2017
Master of Science (M.S.), Nutrition Sciences

North Carolina State University   1998 — 2004
Bachelor of Science (B.S.), Biological and Agricultural Engineering

North Carolina State University   1998 — 2004
Bachelor of Science (B.S.), Biomedical Engineering

Jerilynn Carroll Jerilynn Carroll Greater St. Louis Area Details
Jerilynn Carroll's Commissioning Agents, Inc Experience October 2000 - November 2006
Job Senior Operations Manager, Bioanalytics at Eurofins Pharma Discovery Services
Industry Pharmaceuticals
Experience
Eurofins Pharma Discovery Services  June 2015 - Present
Mallinckrodt Pharmaceuticals  October 2009 - October 2014
Progress Initiatives. LLC   June 2007 - October 2009
Commissioning Agents, Inc   October 2000 - November 2006
Fuisz Technologies  November 1996 - October 2000
Ciba-Geigy  August 1978 - November 1996

Skills
Leadership, Planning, Problem Solving, Decision Making, Developing Others, Coaching, Training, Cross-functional Team..., Manufacturing, Contract Manufacturing, Outsourcing and Vendor..., Packaging, Quality Management, Quality Assurance, Pharmaceutical Industry, Quality System, Regulatory Compliance, FDA, Quality Auditing, GMP, Technology Transfer, Process Improvement, Continuous Improvement, Validation, Computer System..., Cleaning Validation, New Plant Start-up, Commissioning, Regulatory Requirements, Remediation, CAPA, 21 CFR Part 11, Change Control, Medical Devices, V&V, SOP, Regulatory Affairs, Program Management, Biotechnology, R&D, Commercialization, Design of Experiments, GxP, ISO 13485, Design Control, Aseptic Processing, Novel Technologies, Biopharmaceuticals, Process Simulation, safety

Education
New York University - Polytechnic School of Engineering   1994 — 1996
MS

State University of New York College at Brockport   1973 — 1976
BS

Jared Croft Jared Croft Greater Denver Area Details
Jared Croft's Commissioning Agents, Inc Experience 2005 - February 2010
Job Validation Manager at TOLMAR Inc.
Industry Biotechnology
Experience
TOLMAR Inc.  February 2010 - Present
Tolmar Inc.  February 2010 - Present
Amgen  2010 - 2012
Commissioning Agents, Inc   2005 - February 2010
AMGEN  2009 - 2010
AMGEN  2009 - 2010
GSK  2008 - 2009

Skills
Validation, GMP, Change Control, V&V, CAPA, 21 CFR Part 11, FDA, Sop, Aseptic Processing, Computer System..., GxP, Cleaning Validation, Quality System, SOP, Pharmaceutical Industry

Education
Brigham Young University   1998 — 2004
BS, Chemical Engineer

Brigham Young University   1997 — 2004
BS, Chemical Engineering

Julie Stafford Julie Stafford Providence, Rhode Island Area Details
Julie Stafford's Commissioning Agents, Inc Experience June 2000 - July 2001
Job Senior Manufacturing Specialist
Industry Biotechnology
Experience
Genzyme  November 2011 - Present
Genzyme  July 2007 - November 2011
RenaMed Biologics  March 2005 - July 2006
Genzyme  December 2004 - March 2005
BiogenIdec - Cambridge Center   March 2004 - December 2004
Monsanto  June 2001 - October 2003
Commissioning Agents, Inc   June 2000 - July 2001

Skills
CIP, Regulatory Submissions, Technology Transfer, Lifesciences, Computer System..., Environmental..., Kaizen, Lean Transformation, Purification, Quality Assurance, Quality System, Quality Control, FDA, GMP, CAPA, Change Control, Biotechnology

Education
Augusta State University

Tri-County Technical High School

Froilan Ordonez Froilan Ordonez Greater New York City Area Details
Froilan Ordonez's Commissioning Agents, Inc Experience October 2010 - Present
Job Validation Engineer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   October 2010 - Present
Progenics Pharmaceuticals  October 2007 - February 2010
Siemens Water Technologies  June 2005 - October 2007

Skills
Validation, CAPA, Aseptic Processing, 21 CFR Part 11, Change Control, FDA, GMP, Sop, Quality System, GLP, Technology Transfer, Biotechnology, Pharmaceutical Industry, Quality Assurance, GxP, Filtration, Biopharmaceuticals, Commissioning, Testing, SOP

Education
Stevens Institute of Technology   2008 — 2014
Masters, Pharmaceutical Manufacturing

New Jersey Institute of Technology   2000 — 2005
ME, Engineering

Bob Huddy Bob Huddy Hartford, Connecticut Area Details
Bob Huddy's Commissioning Agents, Inc Experience April 2011 - Present
Job Project Manager / Validation Engineer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   April 2011 - Present
Xcellerex, Inc.   October 2008 - January 2011
Watson Pharmaceuticals  2003 - 2008
JDSUniphase  2001 - 2002
Cordis, Johnson and Johnson  1996 - 2000
Ultralife Batteries, Inc.   1992 - 1995
AMTX/Xerox   1989 - 1992

Skills
Project Management, Validation, GMP, CAPA, FDA, Sop, Biotechnology, Quality System, Biopharmaceuticals, Technology Transfer, 21 CFR Part 11, Pharmaceutical Industry, Change Control, V&V, Process Simulation, Design of Experiments, Manufacturing, Quality Assurance, ISO 13485, GLP, Lean Manufacturing, Calibration, Aseptic Processing, Six Sigma, Medical Devices, R&D, Sterilization, Process Engineering, Root Cause Analysis, Quality Management

Education
Rensselaer Polytechnic Institute   1975 — 1980
BS, Mechanical Engineering

Alba Diaz Vega Alba Diaz Vega Puerto Rico area Details
Alba Diaz Vega's Commissioning Agents, Inc Experience March 2014 - Present
Job Validation Scientist at Lilly
Industry Biotechnology
Experience
Commissioning Agents, Inc   March 2014 - Present
DuPont Pioneer  February 2011 - February 2014
Eli Lilly  February 2010 - February 2011
National Cancer Institute  June 2007 - December 2007

Skills
GLP, Microbiology, GMP, Laboratory, Validation, Tissue Culture, Sop, DNA extraction, Fermentation, Animal Models, Cancer Research, Genotyping, Cancer, Bacterial Transformation, Environmental Monitoring, Leadership, Program Management, Media Preparation, Management, Project Planning, ELISA, DNA Extraction, SOP, Biotechnology, Quality Assurance, Life Sciences, PCR, Cell Culture, Pharmaceutical Industry, Molecular Biology, Protein Purification, Western Blotting, Technology Transfer, Chromatography, Research, LIMS, DNA, R, HPLC

Education
Penn State University   2008 — 2009
Master's degree, Biotechnology

University of Puerto Rico   2003 — 2007
Bachelor's degree, Microbiology, General

Jacob Swartz Jacob Swartz Santa Barbara, California Details
Jacob Swartz's Commissioning Agents, Inc Experience September 2009 - August 2014
Job Research and Development Project Manager at Isolite Systems
Industry Pharmaceuticals
Experience
Isolite Systems  September 2014 - Present
Commissioning Agents, Inc   September 2009 - August 2014

Skills
Validation, V&V, GMP, CAPA, Change Control, FDA, 21 CFR Part 11, Computer System..., Quality System, Cleaning Validation, Aseptic Processing, GxP, Quality Assurance, Pharmaceutical Industry, Biotechnology, Biopharmaceuticals

Education
California Polytechnic State University-San Luis Obispo   2004 — 2009
BS, Mechanical Engineering

Sara Hendricks Sara Hendricks Greater Denver Area Details
Sara Hendricks's Commissioning Agents, Inc Experience 2004 - 2009
Job Compliance & Regulatory Affairs Specialist Blood Systems Inc. at Bonfils
Industry Biotechnology
Experience
Bonfils Blood Center (Blood Systems Inc affiliate)   January 2014 - December 2014
Bonfils Blood Center  April 2013 - December 2013
Agilent Technologies  October 2009 - April 2013
Mountain State PDA   2007 - 2009
Commissioning Agents, Inc   2004 - 2009
AlloSource  1999 - 2003

Skills
Validation, GMP, V&V, FDA, Quality System, Biotechnology, CAPA, Sop, 21 CFR Part 11, Change Control, GLP, Quality Assurance, GxP, Technology Transfer, Analytical Chemistry, HPLC, Computer System..., Aseptic Processing, Cleaning Validation, Quality Control, Biopharmaceuticals, Laboratory, Quality Auditing, Quality Management, Root Cause Analysis, Chromatography, ISO 13485, Process Simulation, Pharmaceutical Industry, Medical Devices, R&D, Lifesciences, Regulatory Affairs, GAMP, Life Sciences, SOP

Education
Montana State University-Bozeman
M.S., Chemical Engineering

University of Colorado Boulder
B.A., MCD Biology and Chemistry (Bio)

University of Colorado Denver
M.S., Environmental Sciences

John McLemore John McLemore Seymour, Indiana Details
John McLemore's Commissioning Agents, Inc Experience October 2007 - January 2011
Job Manager, QA Validation at Kremers Urban Pharmaceuticals
Industry Pharmaceuticals
Experience
Kremers Urban Pharmaceuticals  March 2014 - Present
Validation Technologies, Inc.   August 2013 - March 2014
Cook Pharmica  February 2012 - August 2013
ProPharma Group  January 2011 - February 2012
Commissioning Agents, Inc   October 2007 - January 2011
GKM-Global Knowledge Management   April 2006 - September 2007
US Navy  November 1985 - November 2005

Skills
Validation, GMP, FDA, Change Control, CAPA, V&V, GAMP, Sop, Biopharmaceuticals, 21 CFR Part 11, GxP, Quality System, Computer System..., Aseptic Processing, Quality Assurance, SOP

Education
Thomas Edison State College   2001 — 2005
Bachelor of Science (BS) Applied Science and Technology, Nuclear Engineering

Daniel Haun Daniel Haun Greater Boston Area Details
Daniel Haun's Commissioning Agents, Inc Experience August 2004 - Present
Job Senior Engineer at Commissioning Agents Inc.
Industry Biotechnology
Experience
Commissioning Agents Inc.  August 2004 - Present
Commissioning Agents, Inc   August 2004 - November 2010

Education
Brigham Young University   2001 — 2003
BS, chemical engineering

University of Colorado at Denver   1999 — 2001
NA, Chemistry

Ralph Manning Ralph Manning Greater New York City Area Details
Ralph Manning's Commissioning Agents, Inc Experience October 2010 - June 2014
Job Sr. Manager, Tech Services, Validation at MannKind Corporation
Industry Pharmaceuticals
Experience
TBD  September 2015 - Present
MannKind Corporation  June 2014 - September 2015
Commissioning Agents, Inc   October 2010 - June 2014
Validation Lifecycle Engineering, LLC   May 2010 - October 2010
Watson Pharmaceuticals  January 1998 - August 2009

Skills
GMP, CAPA, Validation, Pharmaceutical Industry, SOP, FDA, Quality System, Manufacturing, Change Control, Technology Transfer

Education
The University of Connecticut School of Business   1988 — 1992
MBA, International Business

Clarkson University   1985 — 1987
BS, Mechanical Engineering

Broome Community College   1983 — 1985
AS, Engineering Science

Martin Rochford Martin Rochford Greater Boston Area Details
Martin Rochford's Commissioning Agents, Inc Experience January 2010 - March 2012
Job Validation Engineer at Biogen Idec
Industry Pharmaceuticals
Experience
Fresenius Kabi  September 2015 - Present
Biogen Idec  March 2012 - September 2015
Commissioning Agents, Inc   January 2010 - March 2012
US Navy  August 2008 - January 2010
US Navy  April 2006 - January 2010
US Navy  April 2006 - January 2010
US Navy  August 2001 - March 2006
USS Philadelphia (SSN-690)   August 2001 - March 2006

Skills
Quality Assurance, Commissioning, Preventive Maintenance, Testing, Engineering, Power Plants, Validation, FDA, GMP, CAPA, SOP, Change Control, Biotechnology, Quality System, Pharmaceutical Industry, Technology Transfer

Education
Canterbury School

Thomas Edison State College
Bachelor's Degree, Nuclear Engineering Technology

Rodney Renn Rodney Renn Albany, New York Area Details
Rodney Renn's Commissioning Agents, Inc Experience February 2006 - Present
Job Validation Specialist at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   February 2006 - Present
US Navy  June 1985 - June 2005
US Navy  1985 - 2005

Skills
Nuclear, Navy, Security Clearance, Preventive Maintenance, Quality Assurance, Technical Writing, Troubleshooting, Documentation, Supervisory Skills, Continuous Improvement, Technical Training, Root Cause Analysis, Testing, Risk Assessment, Validation, Engineering, GMP, SOP, Team Building, Commissioning, Automation, Process Development, HVAC, Scheduling, cGMP, Change Control, Electronics, Microsoft Office, Inspection, Cross-functional Team..., Software Documentation, Quality System, Calibration, Process Simulation, Sop, Computer System..., V&V, 21 CFR Part 11

Education
The New School   2004 — 2005
BS, Human Resource Management

Eden Senior High

Gail (Vern) Porter Gail (Vern) Porter Richmond, Virginia Area Details
Gail (Vern) Porter's Commissioning Agents, Inc Experience Nuclear Recruiter / Advanced Programs CoordinatorUS Navy Recruiting CommandOctober 1999 - February 2003
Job Project Manager at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   Nuclear Recruiter / Advanced Programs CoordinatorUS Navy Recruiting CommandOctober 1999 - February 2003
US Navy Submaine Force   February 1983 - February 2003

Skills
Project Management, Air Compressors

Education
Thomas Edison State College
BSAST, Nuclear Engineering Technology

Brenna Olmsted Brenna Olmsted Norfolk, Virginia Details
Brenna Olmsted's Commissioning Agents, Inc Experience December 2011 - July 2012
Job Chemical Engineering
Industry Chemicals
Experience
Commissioning Agents, Inc   December 2011 - July 2012
CAS  June 2010 - November 2010
Honeywell UOP  June 2009 - August 2009
Marathon Oil Company, LLC, Minnesota Refining Division   August 2008 - November 2008
J. I. Case Wetland Faculty Research Grant   June 2008 - August 2008

Skills
Microsoft Office, Microsoft Excel, Troubleshooting, PowerPoint, Research, Microsoft Word, Outlook

Education
Rose-Hulman Institute of Technology   2006 — 2010
Bachelor of Science; Environmental Science, Chemical Engineering major, Environmental Engineering minor

Jeff Borgarding Jeff Borgarding Indianapolis, Indiana Area Details
Jeff Borgarding's Commissioning Agents, Inc Experience November 2005 - Present
Job Maintenance and Reliability Professional at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   November 2005 - Present

Skills
Maintenance Management

Education
National University   1990 — 1997
BBA, Business

Emily Stump Emily Stump Portland, Oregon Area Details
Emily Stump's Commissioning Agents, Inc Experience July 2010 - Present
Job Director of Operations, Pacific Northwest at CAI
Industry Biotechnology
Experience
Commissioning Agents, Inc   July 2010 - Present
BioPharmaceutical Manufacturing and Academic Resource Center (BioMARC) at Colorado State University   May 2007 - July 2010
Colorado State University  January 2007 - May 2007
BioMARC  January 2006 - May 2007
New Belgium Brewing Company  March 2006 - April 2007
Leprino Foods  December 2004 - December 2005

Education
Colorado State University   2008 — 2010
M.S.

Colorado State University   2003 — 2007
B.S., Honors

Andrew Bohlmann Andrew Bohlmann Raleigh-Durham, North Carolina Area Details
Andrew Bohlmann's Commissioning Agents, Inc Experience November 2007 - Present
Job Project Manager at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   November 2007 - Present
US Navy  September 2004 - November 2007
USS San Juan (SSN-751)   2001 - 2004
USS Hartford (SSN-768)   1999 - 2001

Skills
V&V, Validation, Computer System..., Quality Assurance, Change Control, Sop, GAMP, Software Documentation, 21 CFR Part 11, Commissioning, Technical Writing, CAPA, FDA, GMP, Process Engineering, Quality System, Root Cause Analysis, Quality Control, GxP, Automation, Quality Management, Testing, Process Control, Technology Transfer, Biotechnology, Pharmaceutical Industry, LIMS, R&D, Six Sigma, Process Simulation, SOP

Education
DeVry University Phoenix   1983 — 1986
BSEET, Electronics

Aaron Ledbetter Aaron Ledbetter Indianapolis, Indiana Details
Aaron Ledbetter's Commissioning Agents, Inc Experience August 2013 - Present
Job Sr. Software Engineer at Commissioning Agents, Inc
Industry Computer Software
Experience
Commissioning Agents, Inc   August 2013 - Present
Freelance Software Engineering Consultant   June 2011 - Present
Thomson Reuters  July 2011 - August 2013
Manatron  July 2007 - July 2011

Skills
C#, JavaScript, .NET, ASP.NET, SQL Server, Silverlight, HTML + CSS, AJAX, GIS, ESRI, iOS development, ASP.NET AJAX, Enterprise GIS, Microsoft SQL Server, Enterprise Software, Android, VB.NET, C, C++, Java, Visual Studio, Web Services, SQL, HTML, Software Engineering, Objective-C

Education
Indiana University-Purdue University at Indianapolis
B.S. Computer Engineering

Justin W. Smith, EIT Justin W. Smith, EIT Vista, California Details
Justin W. Smith, EIT's Commissioning Agents, Inc Experience 2013 - Present
Job Computer Systems Validation Engineer
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   2013 - Present
Southern California Edison  November 2011 - September 2013
Southern California Edison  March 2010 - November 2011
US Navy  1999 - 2005

Skills
Program Management, Regulatory Requirements, Benchmarking, Corrective Action..., Program Evaluation, Database Administration, Data Mining, Nuclear, Factory, Navy, Plant Operations, Radiation Safety, Nuclear Power Plants, Industrial Safety, Electrical Engineering, Electrical Safety, NERC, Engineering, Planned Preventative..., Electricians, Power Plants, Quality Assurance, Energy, Turbines, Nuclear Engineering, Maintenance & Repair, Steam Turbines, Root Cause Analysis, Steam, CAPA, Reactor, Electric Power, Electricity, Nuclear Safety, Power Distribution, Instrumentation, Preventive Maintenance, Power Generation, Plant Maintenance, Human Performance, Outage Management, Boilers, Electrical..., Maintenance Management, Gas Turbines, Calibration, Steam Generators, Generators, Electrical Controls, Power Systems

Education
California State University San Marcos   2015 — 2016
Current Student, Master in Business Administration and Management, General

Excelsior College   2010 — 2011
B. S. Nuclear Engineering Technology, Nuclear Engineering Technology/Technician, Magna Cum Laude

San Diego Mesa College   2006 — 2009
Engineering, IGETC Transfer requirements

Paul Chudzinski Paul Chudzinski Cleveland/Akron, Ohio Area Details
Paul Chudzinski's Commissioning Agents, Inc Experience January 2014 - March 2015
Job External Manufacturing Project Manager Remote
Industry Pharmaceuticals
Experience
Regeneron Pharmaceuticals, Inc.   March 2015 - Present
Commissioning Agents Inc.  January 2014 - March 2015
Boehringer Ingelheim  July 2012 - February 2014
Boehringer Ingelheim  November 2005 - July 2012
Boehringer Ingelheim  July 2000 - November 2005

Skills
GMP, Validation, Sop, Change Control, FDA, Cleaning Validation, Sterilization, Aseptic Processing, Chromatography, V&V, Quality System, Equipment Qualification, Regulatory Affairs, Trackwise, Computer System..., Pharmaceutics, 21 CFR Part 11, GxP, Pharmaceutical Industry, CAPA, Regulatory Requirements, Manufacturing, Biopharmaceuticals, GLP, Lyophilization, Deviations, Formulation, LIMS, Technology Transfer, Vaccines, Troubleshooting, HPLC, Analytical Chemistry, Depyrogenation, Automated Inspection, Medical Devices, Management, Biotechnology, SOP

Education
Baldwin-Wallace College   1995 — 1999
Bachelor of Science (B.S.), Biology

Robert Jenson Robert Jenson Indianapolis, Indiana Area Details
Robert Jenson's Commissioning Agents, Inc Experience January 2005 - Present
Job Validation Technician at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   January 2005 - Present

Skills
Change Control, Computer System..., V&V, Sop, 21 CFR Part 11, FDA, Quality System, GAMP, CAPA, Trackwise, Quality Assurance, Technical Writing, Equipment Qualification, Biopharmaceuticals, LIMS, GxP, GLP, Calibration, FDA GMP, Pharmaceutical Industry, Technology Transfer, ISO 13485, Sterilization, Biotechnology, Aseptic Technique

Education
Ivy Tech Community College   1993 — 1995
Associate's degree

Ball State University   1988 — 1989

Ken Spradlin Ken Spradlin Indianapolis, Indiana Area Details
Ken Spradlin's Commissioning Agents, Inc Experience January 2005 - Present
Job Project Manager/Validation Specialist/CBCP at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   January 2005 - Present
Air Products and Chemicals  August 1999 - January 2005
Bartlett Nuclear Services   April 1999 - July 1999

Skills
Validation, GMP, Commissioning, Sop, Change Control, Quality System, V&V, Process Engineering, Quality Assurance, FDA, Computer System..., Process Simulation, Nuclear, Process Control, Continuous Improvement, Technical Writing, 21 CFR Part 11, GAMP

Education
Purdue University   2005 — 2015
Mechanical Engineering

California State University-Long Beach

James Karkow James Karkow Holly Springs, North Carolina Details
James Karkow's Commissioning Agents, Inc Experience December 2003 - July 2013
Job President at JDK Consulting, LLC
Industry Pharmaceuticals
Experience
JDK Consulting, LLC   August 2013 - Present
Commissioning Agents, Inc   December 2003 - July 2013

Skills
Process Systems testing..., Change Control, Validation, GMP, FDA, Sop, 21 CFR Part 11, Computer System..., Quality Assurance, V&V, Pharmaceutical Industry, Biotechnology, Quality System, CAPA, Process Engineering, Commissioning

Education
Southern Illinois University, Carbondale
Bachelor of Science (BS), Vocational Education Studies

United States Navy Nuclear Power School

Garth Handlon Garth Handlon Indianapolis, Indiana Details
Garth Handlon's Commissioning Agents, Inc Experience
Job Senior I at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc  

Skills
GMP, Validation, Sop, Change Control, V&V, Computer System..., GAMP, 21 CFR Part 11, CAPA, Quality System, Pharmaceutical Industry, Quality Assurance, Process Engineering, FDA, Biotechnology, Technical Writing, GxP, Engineering, Commissioning, Software Documentation, Calibration, Technology Transfer, Root Cause Analysis, LIMS, GLP, Process Simulation, Pharmaceutics, FDA GMP, Cleaning Validation, Process Control, Medical Devices, Aseptic Processing, Quality Control, SOP

Education
Indiana University-Purdue University at Indianapolis   1968 — 1972
None, Electrical and Electronics Engineering, None

Angel Colucci Angel Colucci Fuquay Varina, North Carolina Details
Angel Colucci's Commissioning Agents, Inc Experience 2004 - 2009
Job QA Compliance Manager at Novartis Vaccines and Diagnostics
Industry Pharmaceuticals
Experience
Novartis Vaccines and Diagnostics  2012 - Present
Novartis Vaccines and Diagnostics  2010 - 2012
Novartis Vaccines and Diagnostics  2009 - 2010
Commissioning Agents, Inc   2004 - 2009
Commissioning Agents, Inc   2001 - 2004
Boston Scientific  2000 - 2001
Boston Scientific  2000 - 2001

Education
Clarkson University
Bachelor of Science (B.S.), Chemical Engineering

Brenna Morgan Brenna Morgan Longmont, Colorado Details
Brenna Morgan's Commissioning Agents, Inc Experience December 2006 - October 2013
Job Program Manager at Hyde Engineering + Consulting
Industry Pharmaceuticals
Experience
Hyde Engineering + Consulting  October 2013 - Present
Commissioning Agents, Inc   December 2006 - October 2013
JM Hyde Consulting  May 2005 - December 2006

Skills
Control System..., Biotech Comminssioning..., Cleaning Validation, Critical and Support..., Process Waste Systems, Emerson DeltaV, RSLogix 5000, Nuclear, Commissioning, V&V, Quality Assurance, GMP, Validation, GAMP, Computer System..., Change Control, Software Documentation, CAPA, Aseptic Processing, FDA, GxP, 21 CFR Part 11, Biopharmaceuticals, Sop, Quality System, Trackwise

Education
Colorado State University   2000 — 2005
Bachelor of Science (B.S.), Chemical Engineering

Keith Vey Keith Vey Greater Philadelphia Area Details
Keith Vey's Commissioning Agents, Inc Experience March 2013 - Present
Job Maintenance Reliability Specialist
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   March 2013 - Present
Westinghouse Electric Company  2004 - 2013
US Navy  December 1994 - December 2003

Skills
Enterprise Asset..., CMMS, SAP PM Module, Maintenance Management, SAP PS, Microsoft Office, Electronics Repair, Electrical..., VBA

Education
Thomas Edison State College   2002 — 2003
Bachelor of Applied Science (B.A.Sc.), Nuclear Engineering Technology/Technician

Naval Nuclear Power School   1995 — 1996

Li Ming Zhang Li Ming Zhang Mountain View, California Details
Li Ming Zhang's Commissioning Agents, Inc Experience September 2013 - Present
Job CQ,Process Engineer at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   September 2013 - Present
Air Liquide (E&C,China)   August 2011 - August 2013

Skills
Validation, V&V, GMP, FDA, CAPA, Change Control

Education
Nanjing University   1993 — 1997
Bachelor of Science (BS), Biochemistry

Jon Lightfoot Jon Lightfoot Baltimore, Maryland Area Details
Jon Lightfoot's Commissioning Agents, Inc Experience June 2010 - Present
Job Director of Operations, MidAtlantic at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc   June 2010 - Present
US Navy  September 1983 - May 2010

Skills
Engineering, Quality Assurance, Commissioning, Project Management, Leadership, FDA, Quality System, CAPA, Validation, GMP, Change Control, Biotechnology, Process Engineering, Manufacturing, SOP, 21 CFR Part 11, Root Cause Analysis, Project Planning, V&V

Education
Thomas Edison State College   2007 — 2010
Bachelor of Science (BS), Nuclear Engineering Technology

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