Commissioning Agents, Inc CAI Consulting
Address: 2601 Fortune Cir Dr E Suite 301B, Indianapolis, IN 46241 Phone: (317) 271-6082: : : : : Category: Website: Hours: : Place name: Website: http://www.commissioningagents.com/ Category: Consultant Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question
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Commissioning Agents, Inc CAI Consulting Employees
Commissioning Agents, Inc CAI Consulting August 2015 - Present
Case Western Reserve University January 2015 - Present
Case Western Reserve University August 2014 - December 2014
AlloSource® June 2014 - August 2014
Case Western Reserve University August 2013 - June 2014
AlloSource May 2013 - August 2013
Public Partnerships 2009 - 2013
University of Colorado School of Medicine May 2012 - August 2012
Skills
Research, Solidworks, Matlab, Tissue Engineering, Finite Element Analysis, Minitab, Microsoft Office, Microsoft Excel, Biomedical Engineering, Cell Culture, SolidWorks, Data Analysis, Microsoft Word
Education
Case Western Reserve University 2011 — 2015
Bachelor of Science (BS), Biomedical/Medical Engineering
Cherry Creek High School 2007 — 2011
Commissioning Agents, Inc CAI Consulting November 2014 - Present
US Navy June 2005 - October 2014
Andy's Cheesesteaks and Cheeseburgers June 2003 - June 2005
Skills
Freeze Seal Supervisor, Safety Technician, Nuclear Repair Mechanic, Engine Room Supervisor, Prison Escort, Security Guard, Security Clearance, JLG Operator, Fall Protection, EPA Certified, Training, Navy, Nuclear, Government, Time Management, Maintenance & Repair, Military, Military Training, Military Experience, Reactor, Military Operations, Nuclear Engineering, DoD, Force Protection, Quality Assurance, National Security, Supervisory Skills, Defense
Education
Thomas Edison State College 2013 — 2017
West Johnston High School 2002 — 2005
High School Diploma
Clayton High School 2001 — 2002
Commissioning Agents, Inc CAI Consulting July 2015 - Present
North Carolina State University August 2013 - July 2015
Novozymes May 2013 - August 2013
Biogen Idec May 2012 - August 2012
North Carolina State University 2008 - 2012
Bayer CropScience May 2010 - August 2010
Skills
German, Russian, French, DNA sequencing, SDS-PAGE, ELISA, Western Blotting, Pro Engineer, AutoCAD, AKTA, Unicorn, Spectroscopy, PCR, ABB SATT controllers, Delta V, LIMS, FTIR, Microsoft Word, Microsoft Excel, SATT, Chromatography, Purification, Fermentation, Biotechnology, Laboratory
Education
North Carolina State University 2014 — 2015
Master of Biomanufacturing & Master of Business Administration, Biomanufacturing
North Carolina State University 2008 — 2013
Biological Engineering: Bioprocessing concentration, Biological/Biosystems Engineering, Senior
Commissioning Agents, Inc CAI Consulting March 2015 - Present
Commissioning Agents, Inc CAI Consulting September 2014 - Present
Williams Scotsman October 2013 - September 2014
Polymer-Wood Technologies November 2012 - October 2013
Pavestone Company February 2009 - September 2012
Pavestone Company April 2005 - February 2009
USS VIRGINIA (SSN 774) April 2000 - March 2005
United States Navy Senior Enlisted Academy January 2000 - March 2000
USS BOSTON (SSN 703) October 1997 - January 2000
Naval Nuclear Power School February 1994 - September 1997
Skills
Lean Manufacturing, Manufacturing, Purchasing, Pavers, Concrete, Supply Chain Management, Transportation, Organizational..., Contract Negotiation, Process Improvement, Process Management, Financial Analysis, Operations Management, Cement, Materials Management, Materials, Packaging, Team Leadership, Leadership Development, Strategic Leadership, Training, Curriculum Development, Retaining Walls, Quality Assurance, Quality Management, Coaching, Inventory Management, Manufacturing..., Maintenance Management, Continuous Improvement, Root Cause Analysis, P&L Management, Forecasting, Engineering, Strategic Planning, Team Building, Organizational Behavior, Reliability Centered..., Curriculum Design, Mentoring, Multisite Manufacturing..., Process Analysis and..., Capital Management, Logistics Management, Joint Ventures, Investor Relations, Strategy, Leadership, Start-ups, Management
Education
The University of Texas at Arlington 2010 — 2016
Working Toward Doctor of Philosophy (Ph.D.), Operations Management
Southern Methodist University - Cox School of Business 2007 — 2009
MBA, Small Business Administration/Finance
Rensselaer Polytechnic Institute 2000 — 2003
Master's of Science, Computer Science, Computer Science
Columbia College 1994 — 1996
BS of Business, Information Technology
Nuclear Power School 1983 — 1985
Nuclear Power Technology & Operations, 3.68
Commissioning Agents, Inc CAI Consulting June 2015 - Present
Prometheus Energy December 2013 - June 2015
United States Navy November 2012 - November 2013
US Navy December 2004 - November 2013
US Navy June 2009 - February 2011
US Navy August 2008 - February 2011
US Navy November 2007 - February 2011
Regional Southwest June 2002 - December 2004
Skills
Quality Assurance, Scuba Diving, Radiation Protection, Radiation Monitoring, Radiation Safety, Maintenance Supervision, Nuclear Engineering, Nuclear, Nuclear Power Plants, Mechanical Engineering, Management, Inspection, Power Plants, Reactor, Navy, Military Operations, Military, Troubleshooting, Security Clearance, DoD, Military Experience
Education
Excelsior College 2013 — 2015
Bachelors Degree, Nuclear Engineering Technology
Commissioning Agents, Inc CAI Consulting October 2014 - Present
Rose-Hulman Institute of Technology September 2011 - February 2014
NextEra Energy Point Beach June 2013 - August 2013
Xcel Energy May 2012 - August 2012
Skills
Matlab, Thermodynamics, Solidworks, Fluid Mechanics, Solid Edge, SolidWorks, Maple, Mechanical Engineering, Microsoft Word
Education
Rose-Hulman Institute of Technology 2011 — 2014
Bachelor of Science (BS), Mechanical Engineering
Commissioning Agents, Inc CAI Consulting December 2014 - Present
International Technology Center March 2010 - July 2014
Kelly Consulting, LLC October 2008 - September 2010
North Carolina State University November 2005 - June 2009
Skills
Project Management, Project Planning, Cross-functional..., Instrument Qualification, Process Validation, Pharmaceutical..., Chemical Engineering, Chemistry, Spectroscopy, Experimentation, Characterization, CVD, Nanotechnology, Heterogeneous Catalysis, Atomic Layer Deposition, Surface Chemistry, Catalysis, Design of Experiments, Materials Science, Fermentation, Microbial Fermentation, Mammalian Cell Culture, Biotechnology, Reactor Design, Plasma Science, Thin Films, Semiconductor Process..., Technical Presentations, Sputtering, XPS, Grant Writing, Nanoparticles, Proposal Writing, Scientific Writing, FTIR, Reaction Engineering, Electronic Materials, Mass Spectrometry (MS), Gas and Liquid...
Education
North Carolina State University 2001 — 2005
Doctor of Philosophy (Ph.D.), Chemical Engineering, magna cum laude
North Carolina State University 1998 — 2001
Master of Science (M.S.), Chemical Engineering, magna cum laude
Case Western Reserve University 1994 — 1998
Bachelor of Science (B.S.), Chemistry, magna cum laude
Case Western Reserve University 1994 — 1998
Bachelor of Science (B.S.), Chemical Engineering, magna cum laude
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 CAI Consulting April 2015 - Present
Contractor October 2014 - April 2015
Mercy February 2013 - September 2014
Schneider Electric March 2011 - January 2013
Schneider Electric September 2007 - April 2011
American Power Conversion September 2007 - March 2011
APC by Schneider Electric December 2002 - August 2007
Skills
Access, Visio, MS Project, Outlook, Staff Development, Instructional Design, Internet Explorer, Customer Events, Data Center, Technical Training, Customer Satisfaction, Solution Selling, Cross-functional Team..., Team Leadership, Team Building, Project Planning, PowerPoint, Team Management, Direct Sales, Professional Services, Microsoft Word, Microsoft Excel, Solution Architecture, IT Solutions, UPS systems, Power Distribution, Project Management, Program Management, PMP, Energy Efficiency, Energy Management, Training, Integration, Product Management, Analysis, Channel Partners, Competitive Analysis, Sales, Strategic Planning, Market Research, Start-ups, Budgets, CRM, Leadership, Business Strategy, Process Improvement, Proposal Writing, Operations Management, Management, Vendor Management
Education
Villanova University 2007 — 2007
Certificate, Project Management
University of Massachusetts Dartmouth 1995 — 2000
BS, Marketing
Uxbridge High School 1991 — 1995
Commissioning Agents, Inc CAI Consulting November 2014 - Present
Sandoz April 2012 - October 2014
Anchen Pharmaceuticals, Inc. February 2004 - March 2012
Skills
Validation, FDA, V&V, CAPA, Pharmaceutical Industry, GMP, Quality System, Sop, Technology Transfer, ISO 13485, Change Control, Lean Manufacturing, Manufacturing, 21 CFR Part 11, Quality Assurance, SOP
Education
De La Salle University 1998 — 2003
BS, Manufacturing Engineering and Management
St Andrew's School 1988 — 1998
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 CAI Consulting May 2015 - Present
U.S. Nuclear Regulatory Commission April 2008 - April 2015
Eastman Chemical Company August 2006 - December 2006
General Mills June 2006 - August 2006
Skills
Computer Skills (Word,..., Quality Assurance, Chemical Engineering, Engineering, Process Engineering, Mac OS, Process Simulation, Safety Analysis, Data Analysis, Cross-functional..., Talent Selection and..., Process Recommendations, Executive Communications, RASCAL, Project Management, Technical Support, Staff Management
Education
University of Puerto Rico-Mayaguez 2002 — 2007
Bachelor of Science (B.S.), Chemical Engineering
Commissioning Agents, Inc CAI Consulting January 2015 - Present
Novartis Vaccines and Diagnostics June 2011 - December 2014
Talecris Biotherapeutics May 2010 - August 2010
Skills
cGMP, GDP, Chromatography, UF/DF, Centrifugation, SDS-PAGE, Cell Culture, PCR, GMP, ELISA, Validation, LIMS, Protein Chemistry, Biotechnology, Purification, SOP
Education
North Carolina State University 2007 — 2011
BS, Bioprocessing Science
Commissioning Agents, Inc CAI Consulting October 2014 - Present
Schneider Electric September 1993 - October 2014
U.S. Navy August 1991 - September 1993
U.S. Navy May 1987 - September 1993
US Navy 1987 - 1993
Skills
UPS systems, Solution Selling, Kaizen, Energy Management, Team Building, Training, Project Management, Facilities Management, Data Center, Power Distribution, Electricians, Process Improvement, Leadership, Program Management, Automation, Key Account Management, Infrastructure, Presenter, Operations Management, Cross-functional Team..., Engineering, Product Management, Electrical Engineering, Vendor Management, Manufacturing, Electronics, Team Leadership, Direct Sales, Project Planning, Power Systems, Change Management, Management, Product Marketing, Energy Efficiency, HVAC, Sales Operations, Building Relationships, Account Management, UPS Systems
Education
United States Naval Academy 1983 — 1987
B.S., Mathematics
Wright State University 2008 — 2010
Masters, MBA, International Business
Commissioning Agents, Inc CAI Consulting March 2015 - Present
Heartland Food Products Group May 2014 - March 2015
Covance May 2013 - May 2014
AYS, Inc. November 2012 - May 2013
Cookie Crumbs Daycare/Preschool April 2002 - November 2012
Indiana Commission on Proprietary Education November 1995 - April 2002
Skills
Accounting, Account Reconciliation, Financial Accounting, Microsoft Excel, Financial Reporting, Microsoft Office, General Ledger, Tax, Accounts Payable, Auditing, Microsoft Word, ERP Software, Financial Forecasting, Variance Analysis, Process Improvement, Financial Statements, Fixed Assets, Cash Management, Finance, Accruals, Accounts Receivable, Supervisory Skills
Education
Indiana Wesleyan University 2012 — 2014
Master of Business Administration (M.B.A.), Accounting and Finance, 3.90 GPA
Illinois State University
Bachelor of Science (BS), Financial Accounting, and Business Systems Analysis and Design
Commissioning Agents, Inc CAI Consulting December 2014 - Present
US Navy May 2011 - April 2014
Skills
Problem Solving, Strategic Planning, Analysis, Public Speaking, Critical Thinking, Time Management, Team Leadership, Adaptability, Military Operations, Military, Military Experience, National Security, Leadership, Microsoft Office, Security Clearance, DoD, Navy, Weapons, Nuclear
Education
United States Naval Academy 2007 — 2011
Bachelor of Science and History, Near and Middle Eastern Studies, 3.54
Validation Technologies, Inc. January 2012 - Present
Commissioning Agents, Inc CAI Consulting April 2007 - January 2012
ESPN September 2003 - April 2007
US Navy April 1983 - September 2003
US Navy January 2001 - August 2003
US Navy January 1997 - January 2001
US Navy November 1993 - December 1996
US Navy June 1991 - October 1993
US Navy September 1989 - May 1991
US Navy May 1987 - August 1989
Skills
Project Management, Team Leadership, Cross-functional Team..., Client Relations, Budget Management, Budget Forecasts, Project Planning, Project Coordination, Biotechnology..., Pharmaceutical..., Intercultural..., Critical Utilities, Environmental Monitoring, Water for Injection..., Clean Steam Generation..., Automation, Critical gases, Analytical Instruments, Equipment Validation, Cleaning Validation
Education
University of New Haven 2003 — 2005
Master of Business Administration (MBA), Business Administration and Management, General
Charter Oak State College 2001 — 2003
Bachelor of Applied Science (BASc), General Studies
Commissioning Agents, Inc CAI Consulting January 2015 - Present
Bloomington Symphony Orchestra (Indiana) February 2014 - Present
Girls Incorporated of Monroe County July 2014 - January 2015
Girls Incorporated of Monroe County April 2012 - September 2014
Cook Pharmica August 2011 - March 2012
Brides by Demetrios June 2008 - July 2009
Skills
Volunteer Management, Volunteer Recruiting, Volunteer Training, Program Development, Program Management, Program Evaluation, Teaching, Nonprofits, Community Outreach, Fundraising, Grants, Public Speaking, Event Planning, Stewardship, Grant Writing, Social Media, Microsoft Office
Education
Butler University 2009 — 2011
Master's degree, Music Performance
Butler University 2004 — 2008
Bachelor of Science (B.S.), Mathematics
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
GSK 2014 - Present
GSK 2007 - 2014
Commissioning Agents, Inc CAI Consulting 2002 - 2007
US Navy 1996 - 2002
Skills
Validation, CAPA, Quality Assurance, Risk Management, SOP Development, PLC, Solid Oral Dosage Forms, Pharmaceutical Industry, Lean Six Sigma, Continuous Improvement, Aseptic Processing, Mechanical Systems, Project Management, GMP, Change Control, FDA, SOP, Customer-focused Service, Biotechnology, 21 CFR Part 11, Technology Transfer, Six Sigma
Education
Campbell University
Bachelor's Degree, Applied Sciences
Excelsior College
Associate's Degree, Nuclear Engineering Technologies/Technicians
Clinical Research Management, Inc. (ClinicalRM) March 2015 - Present
Commissioning Agents, Inc CAI Consulting June 2013 - March 2015
5-hour ENERGY® April 2010 - March 2013
GlaxoSmithKline Biologicals April 2009 - April 2010
Analytical Laboratory Services October 2007 - April 2009
Skills
Project Planning, Project Management, Method Transfer, Microbiological Method..., Rapid Microbiological..., Equipment Qualification, Validation, Media Preparation, Pathogen Analysis, Bioburden, cGMP, FDA, HPLC, start-up microbiology..., GMP, Laboratory, Aseptic Processing, 21 CFR Part 11, GLP, Quality System, Biotechnology, V&V, Quality Control, SOP, CAPA, Microbiology, FDA GMP
Education
Indiana University of Pennsylvania 2003 — 2007
B.S., Biology, Chemistry
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 CAI Consulting August 2014 - Present
BioPharma Consulting JAD Group 2013 - 2014
Pfizer Pharmaceuticals 2007 - 2014
URS 2007 - 2013
Becton Dickinson - Mexico August 2008 - November 2008
Washington Group International October 2000 - November 2007
URS, formerly Washington Group Intl. 2004 - 2006
Merck Sharp & Dohme 2002 - 2004
Quantum Industrial January 1997 - March 2000
UPS 1989 - 1994
Skills
Validation, FDA, ASTM, cGMP, Computer System..., Change Control, GMP, SOP, Quality Systems, Commissioning, 21 CFR Part 11, Pharmaceuticals, Documentation, Compliance, Biotechnology, Testing, CAPA, GxP, Validations, Environmental Monitoring, Process Equipment, CIP, Risk Management, Remediation, HVAC, Quality System, Pharmaceutical Industry, V&V, Sop, Regulatory Requirements, GAMP, ISO, Biopharmaceuticals, Document Management, Analytical Chemistry, Quality Auditing, Cleaning Validation, Laboratory, Quality Management, Quality Control, Process Engineering, LIMS, Software Documentation, Quality Assurance, Technology Transfer, Root Cause Analysis, Regulatory Affairs, Calibration, Process Simulation, HPLC
Education
Miami Dade College 1987 — 1991
Colegio San Agustin-Cabo Rojo
Colegio San Agustin-Cabo Rojo
Colegio San Agustin-Cabo Rojo
Commissioning Agents, Inc CAI Consulting April 2015 - Present
Covidien August 2007 - April 2015
PepsiCo February 2006 - April 2007
Abbott Laboratories 1997 - 2005
Skills
Lean Manufacturing, Electrical Engineering, Project Management, Medical Devices, Validation, Testing, Six Sigma, Root Cause Analysis, Quality System, Quality Assurance, Process Engineering, Manufacturing, Engineering, FDA, Continuous Improvement, CAPA, Automation, ISO 13485, Quality Management, Quality Control, FMEA
Education
Keller Graduate School - DeVry University 2003 — 2007
Master’s Degree, Business Administration
Clemson University 1991 — 1997
Bachelor’s Degree, Electrical 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
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
University of Nebraska Medical Center February 2011 - Present
Biogen Idec February 2011 - Present
Biogen 2014 - 2015
Biogen 2014 - 2015
Commissioning Agents, Inc CAI Consulting 2013 - 2014
Commissioning Agents, Inc CAI Consulting 2013 - 2014
Commissioning Agents, Inc CAI Consulting 2013 - 2014
University of Arkansas January 2005 - September 2011
Virtual Incubation Inc. (Fayetteville, Arkansas, USA) January 2004 - December 2005
University of Arkansas August 2001 - August 2003
Education
University of Arkansas at Fayetteville 2005 — 2009
PhD, Mechanical Engineering
Commissioning Agents, Inc CAI Consulting June 2015 - Present
Oil and Gas Exploration June 2013 - September 2014
AMD September 2011 - December 2012
Dell Computer September 2006 - September 2011
Plasmon 2001 - 2006
Agilent Technologies March 2001 - April 2002
CellPort Systems October 2000 - March 2001
Axiohm Inc January 1999 - October 2000
Skills
Team Building, Team Leadership, Timely Decision Making, Data-driven Decision..., Identifying New..., Identifying Process..., Technical Leadership, Technical Communication, P&L Ownership, Feature Definition, Defining Product..., Product Development, Product Management, Product Lifecycle..., Engineering, Cross-functional Team..., Program Management, Management, Project Management
Education
University of Florida 1994 — 1998
BSEE, Electrical Engineering
Compliance Team, Inc. March 2015 - Present
Commissioning Agents, Inc CAI Consulting August 2014 - March 2015
Validant 2012 - 2014
Jacobs Engineering September 1999 - July 2012
Jacobs Engineering 1999 - 2012
Skills
P&ID, Detail Engineering, Process Simulation, Engineering, Commissioning, EPC, Quality System, Change Control, V&V, Quality Assurance, Inspection, Validation, Piping, Quality Management, PLC, Chemical Engineering, GAMP, SOP, GMP, Pharmaceutical Industry
Education
Rose-Hulman Institute of Technology 1993 — 1995
B.S. ChemE, Chemical Engineering
Vincennes University 1991 — 1993
Associate of Science (A.S.), Chemistry
Commissioning Agents, Inc CAI Consulting October 2014 - Present
Shire 2015 - 2015
Commissioning Agents, Inc CAI Consulting 2014 - 2014
Noramco, a Johnson and Johnson company 2006 - June 2013
Lohmann Therapy Systems (LTS) 2004 - 2005
Hoechst Celanese 1994 - 1996
Skills
Product Development, Cross-functional Team..., GMP, Project Management, Management, Technology Transfer, Validation, Process Improvement, Process Engineering, Design of Experiments, Team Facilitation, DEA, Import/Export Operations, Quality Systems, Regulatory Requirements, Global Communications, Cleaning, Program Management, Quality System, R
Education
Auburn University
Master of Science (M.S.), Chemical Engineering
Commissioning Agents, Inc CAI Consulting May 2015 - Present
Oracle March 2013 - April 2015
Welch Allyn November 2002 - March 2013
Westaff October 2001 - November 2002
Sure Power March 2000 - October 2001
Skills
Design test fixtures..., Excellence in..., CAPA, Medical Devices, Quality System, Lean Manufacturing, FDA, Validation, Manufacturing, Design for Manufacturing, Manufacturing..., Continuous Improvement, ISO, Manufacturing..., Six Sigma, Electronics, Kaizen, Value Stream Mapping, Troubleshooting, Test Fixtures, Maintenance & Repair, Quality Auditing, Testing, FMEA, Root Cause Analysis, Cross-functional Team..., Failure Analysis, V&V, Quality Control, Software Documentation, Calibration, DMAIC, ICT, Process Engineering, Automation, Engineering Management, Design of Experiments, Quality Assurance, Supplier Quality, GMP, Engineering, Industrial Engineering, PCB design, 5S, Kanban, Quality Management, Iso 9000, R&D, Product Development, MRP
Education
ITT 1998 — 2002
Bachelors, Automated Manufacturing Technologies (AMT)
ITT Technical Institute-Portland 1998 — 2000
Associate's degree, Electrical and Electronics Engineering
Commissioning Agents, Inc CAI Consulting December 2011 - Present
AFI, Puerto Rico May 2011 - December 2011
Díaz Paunetto Arquitectos, LLC October 2010 - February 2011
Skills
Sustainable Design, Architectural Design, Design Research, Green Building, HVAC Controls, Document Management, Project Planning, LEED AP, Design, Lighting Control, Energy Efficiency, AutoCAD, SketchUp, 3D Architectural..., Microsoft Excel, Performance Metrics, Microsoft Office, Architecture, Architectural Drawings, Photoshop, Urban Design, Construction Drawings, Comprehensive Planning, Space Planning, Mixed-use, Rendering, AutoCAD Architecture, Adobe Creative Suite, LEED, Sustainability, Project Management, Model Making, CAD
Education
University of Puerto Rico-Rio Piedras 2001 — 2008
Master of Architecture (M.Arch.), Architecture
Commissioning Agents, Inc CAI Consulting August 2015 - Present
Novozymes October 2012 - August 2015
Cree September 2010 - September 2012
Education
North Carolina State University 2013 — 2015
Master’s Degree, Biomanufacturing
North Carolina State University 2006 — 2010
B.S. Biological Engineering
Commissioning Agents, Inc CAI Consulting September 2014 - Present
Mentor Technical Group August 2012 - September 2014
Amgen July 2006 - April 2012
Ethicon November 2004 - July 2006
BD August 2001 - November 2004
EMD Millipore November 1999 - August 2001
Skills
Validation, FDA, Design of Experiments, Design Control, CAPA, V&V, Change Control, Quality System, GMP, ISO 13485, Technology Transfer, Root Cause Analysis, Minitab, 21 CFR Part 11, FMEA, Calibration, Quality Control, Quality Auditing, Computer System..., Process Simulation, Medical Devices, ISO, GAMP, Quality Assurance
Education
Universidad Politecnica de PR 2000 — 2002
Master's degree, Engineering Management
Temple University
Bachelor's degree, Mechanical Engineering
Colegio San Jose
Commissioning Agents, Inc CAI Consulting March 2015 - Present
FDA May 2012 - August 2014
Skills
Laboratory, ELISA, LC-MS, Testing, Research, Chemistry, Materials Science, HPLC, Data Analysis, R&D
Education
University of Illinois at Urbana-Champaign 2010 — 2014
Bachelor's degree, Chemical Engineering, 2014
US Navy December 1995 - Present
Commissioning Agents, Inc CAI Consulting 2013 - 2015
Commissioning Agents, Inc CAI Consulting 2013 - 2015
Commissioning Agents, Inc CAI Consulting 2013 - 2015
Commissioning Agents, Inc CAI Consulting 2013 - 2015
Commissioning Agents, Inc CAI Consulting 2013 - 2015
Reliable Electric October 1987 - November 1993
Skills
Navy, Security Clearance, Military, Military Experience, Military Operations, DoD, Operational Planning, Nuclear, Force Protection, Nuclear Engineering, Military Training, Command, Plant Operations, Maintenance & Repair, Engineering, Preventive Maintenance, Reactor, Maintenance Management
Education
The University of Akron 1987 — 1989
Padua Franciscan High School 1983 — 1987
Commissioning Agents, Inc CAI Consulting January 2013 - Present
Skills
Engineering, Testing, Quality Assurance, FDA, Process Engineering, Change Control, Manufacturing, V&V, GMP, Lean Manufacturing, Root Cause Analysis
Education
Kettering University 2009 — 2011
Master of Science (MS), Manufacturing Operations
Morgan State University 2003 — 2007
Bachelor's degree, Electrical and Computer Engineering
Belcan Engineering May 2014 - Present
Belcan Engineering August 2009 - May 2014
Belcan Engineering October 2008 - August 2009
Covidien September 2007 - October 2008
Commissioning Agents, Inc CAI Consulting February 2005 - September 2007
Education
Indiana Wesleyan University 2005 — 2008
Master of Business Administration (M.B.A.), Business Administration and Management, General
Thomas Edison State College 2002 — 2004
B.S. Applied Science and Technology - Nuclear Power, Nuclear Engineering Technology/Technician
Saint Louis Community College-Florissant Valley 1995 — 1996
General Studies