Commissioning Agents, Inc
Industry: Company
DescriptionFounded: 1996 Subsidiary: Commissioning Agents International, Inc.
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Commissioning Agents, Inc Employees
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Commissioning Agents Inc project managercommissioning agents1996 - 2009
commissioning agents 1996 - 2008
Skills
Validation
Education
Indiana University-Purdue University at Indianapolis 1992 — 1997
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Commissioning Agents, Inc November 2005 - Present
Skills
Maintenance Management
Education
National University 1990 — 1997
BBA, Business
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
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
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
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
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
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
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
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
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
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
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
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
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
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