Performance Validation
Industry: Company
DescriptionFounded: 1988 Parent organization: Performance Solutions, LLC
Performance Validation List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Performance Validation. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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Performance Validation Employees
Employee
Years
Job
Industry
David Tebbe David Tebbe's Performance Validation Experience June 2014 - Present
Job Validation Engineer at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation June 2014 - Present
Performance Validation June 2012 - June 2014
Skills
Validation, GDP, Qualification..., GMP, Commissioning, FDA GMP
Education
Rose-Hulman Institute of Technology 2008 — 2012
Bachelor of Science (B.S.), Mechanical Engineering
Performance Validation June 2014 - Present
Performance Validation June 2012 - June 2014
Skills
Validation, GDP, Qualification..., GMP, Commissioning, FDA GMP
Education
Rose-Hulman Institute of Technology 2008 — 2012
Bachelor of Science (B.S.), Mechanical Engineering
Kaitlyn Lewis's Performance Validation Experience August 2012 - December 2014
Job Validation Engineer at Avery Dennison
Industry Medical Devices
Experience
Avery Dennison January 2015 - Present
Performance Validation August 2012 - December 2014
Rose-Hulman Institute of Technology September 2010 - May 2012
Odelia's Catering Service May 2008 - August 2011
Skills
Biomedical Engineering, Pharmaceutical..., Pharmaceutical Packaging, Validation, Commissioning and..., Equipment Qualification, Temperature Mapping, Technical Documentation, cGMP, 21 CFR Part 11, GAMP, ISPE Guidelines, Matlab, Minitab, Solid Edge, Microsoft Office, Circuit Design, Aseptic Technique, GMP
Education
Rose-Hulman Institute of Technology 2008 — 2012
Bachelor of Science (B.S.), Biomedical Engineering
Owensboro Catholic High School 2004 — 2008
Commonwealth Honors Diploma
Avery Dennison January 2015 - Present
Performance Validation August 2012 - December 2014
Rose-Hulman Institute of Technology September 2010 - May 2012
Odelia's Catering Service May 2008 - August 2011
Skills
Biomedical Engineering, Pharmaceutical..., Pharmaceutical Packaging, Validation, Commissioning and..., Equipment Qualification, Temperature Mapping, Technical Documentation, cGMP, 21 CFR Part 11, GAMP, ISPE Guidelines, Matlab, Minitab, Solid Edge, Microsoft Office, Circuit Design, Aseptic Technique, GMP
Education
Rose-Hulman Institute of Technology 2008 — 2012
Bachelor of Science (B.S.), Biomedical Engineering
Owensboro Catholic High School 2004 — 2008
Commonwealth Honors Diploma
Angela Starner's Performance Validation Experience August 2010 - August 2013
Job Validation Engineer at PharmaForce Inc.
Industry Pharmaceuticals
Experience
PharmaForce Inc. August 2013 - Present
Performance Validation August 2010 - August 2013
Medivative Technologies June 2009 - August 2009
Skills
Validation, GMP, FDA, CAPA, 21 CFR Part 11, Pharmaceutical Industry, V&V, Quality System, Change Control, SOP, Engineering, Biomedical Engineering, Manufacturing, Regulatory Affairs, Design of Experiments, Parenteral, Sterilization, Water Quality, Clean Utilities, ISPE, PDA, Microsoft Office, Medical Devices, 21 CFR, Tablet Technology, Clean Rooms, Computer System..., Minitab, Software Documentation
Education
Rose-Hulman Institute of Technology 2006 — 2010
Bachelors, Biomedical Engineering
PharmaForce Inc. August 2013 - Present
Performance Validation August 2010 - August 2013
Medivative Technologies June 2009 - August 2009
Skills
Validation, GMP, FDA, CAPA, 21 CFR Part 11, Pharmaceutical Industry, V&V, Quality System, Change Control, SOP, Engineering, Biomedical Engineering, Manufacturing, Regulatory Affairs, Design of Experiments, Parenteral, Sterilization, Water Quality, Clean Utilities, ISPE, PDA, Microsoft Office, Medical Devices, 21 CFR, Tablet Technology, Clean Rooms, Computer System..., Minitab, Software Documentation
Education
Rose-Hulman Institute of Technology 2006 — 2010
Bachelors, Biomedical Engineering
Pamela Jansen Pamela Jansen's Performance Validation Experience September 2014 - Present
Job Validation Engineer
Industry Pharmaceuticals
Experience
Performance Validation September 2014 - Present
LA Fitness 2005 - 2009
CSL Behring 2001 - 2003
Mallinckrodt Pharmaceuticals 1994 - 2001
Skills
GMP, Cleaning Validation, Validation, Change Control, Sop, Computer System..., Equipment Qualification, Pharmaceutical..., Deviation Management, V
Education
University of Illinois at Urbana-Champaign
Bachelor's degree, Chemical Engineering, Cum Laude
College of Lake County
Chemical Engineering
Performance Validation September 2014 - Present
LA Fitness 2005 - 2009
CSL Behring 2001 - 2003
Mallinckrodt Pharmaceuticals 1994 - 2001
Skills
GMP, Cleaning Validation, Validation, Change Control, Sop, Computer System..., Equipment Qualification, Pharmaceutical..., Deviation Management, V
Education
University of Illinois at Urbana-Champaign
Bachelor's degree, Chemical Engineering, Cum Laude
College of Lake County
Chemical Engineering
Diana Nordling's Performance Validation Experience 2001 - 2006
Job Director at Cincinnati Childrens Hospital Medical Center
Industry Biotechnology
Experience
Cincinnati Childrens Hospital Medical Center 2006 - Present
Pharmaceutical Calibrations and Instrumentation 2004 - 2006
Performance Validation 2001 - 2006
Roche Diagnostics 2005 - 2005
Alkermes 1999 - 2000
Pharmacia 1994 - 1999
Skills
Validation, FDA, Project Management, Gene Therapy, Cell Therapy, Change Management, Healthcare, Risk Assessment, Operations Management, IVD, Medical Devices, Pharmaceutical Industry, Biotechnology, Biopharmaceuticals, CSV, Technology Transfer, Quality Management, Microbiology, Leadership, Strategic Planning, Process Improvement, Stability Studies, FDA GMP, Consulting, Root Cause Analysis, Clinical Research, Clean Rooms, Sop, GLP, 21 CFR Part 11, CAPA, Regulatory Affairs, Clinical Trials, Regulatory Submissions, Quality System, Cell Culture, GCP, Drug Development, Vaccines, Change Control, General Awesomeness, V&V, Regulatory Requirements, SOP
Education
Northern Kentucky University 2000 — 2003
bs
Maysville Community College 1999 — 2000
as
Alice Lloyd College 1998 — 1999
Cincinnati Childrens Hospital Medical Center 2006 - Present
Pharmaceutical Calibrations and Instrumentation 2004 - 2006
Performance Validation 2001 - 2006
Roche Diagnostics 2005 - 2005
Alkermes 1999 - 2000
Pharmacia 1994 - 1999
Skills
Validation, FDA, Project Management, Gene Therapy, Cell Therapy, Change Management, Healthcare, Risk Assessment, Operations Management, IVD, Medical Devices, Pharmaceutical Industry, Biotechnology, Biopharmaceuticals, CSV, Technology Transfer, Quality Management, Microbiology, Leadership, Strategic Planning, Process Improvement, Stability Studies, FDA GMP, Consulting, Root Cause Analysis, Clinical Research, Clean Rooms, Sop, GLP, 21 CFR Part 11, CAPA, Regulatory Affairs, Clinical Trials, Regulatory Submissions, Quality System, Cell Culture, GCP, Drug Development, Vaccines, Change Control, General Awesomeness, V&V, Regulatory Requirements, SOP
Education
Northern Kentucky University 2000 — 2003
bs
Maysville Community College 1999 — 2000
as
Alice Lloyd College 1998 — 1999
Lukeus Allen Lukeus Allen's Performance Validation Experience January 2011 - March 2012
Job Process Excellence Lead at Covance
Industry Management Consulting
Experience
Covance March 2012 - Present
Performance Validation January 2011 - March 2012
Accenture April 2010 - January 2011
Eli Lilly and Company September 2009 - April 2010
Eli Lilly and Company December 2005 - September 2009
Eli Lilly and Company March 2002 - December 2005
Eli Lilly and Company via Kelly Services September 2000 - March 2002
Reilly Industries, via Aerotek June 2000 - September 2000
Skills
DMAIC, GMP, Continuous Improvement, Lean Manufacturing, SPC, 5S, Kaizen, Project Management, Analytical Chemistry, DFSS, Six Sigma, Pharmaceutical Industry, Quality Assurance, Medical Devices, Biotechnology, Quality System, Root Cause Analysis, Process Improvement, CAPA, Training, FDA, HPLC, Validation, Sop, Quality Control, 21 CFR Part 11, Manufacturing, Change Control, Computer System..., V&V, Chromatography, Testing, SOP
Education
Arizona State University, IRA School of Engineering 2011 — 2011
Certified, Six Sigma Master Black Belt
Cedarville University 1996 — 2000
Bachelors, Chemistry
Indiana University School of Medicine
Graduate, Biotechnology Training Program
Covance March 2012 - Present
Performance Validation January 2011 - March 2012
Accenture April 2010 - January 2011
Eli Lilly and Company September 2009 - April 2010
Eli Lilly and Company December 2005 - September 2009
Eli Lilly and Company March 2002 - December 2005
Eli Lilly and Company via Kelly Services September 2000 - March 2002
Reilly Industries, via Aerotek June 2000 - September 2000
Skills
DMAIC, GMP, Continuous Improvement, Lean Manufacturing, SPC, 5S, Kaizen, Project Management, Analytical Chemistry, DFSS, Six Sigma, Pharmaceutical Industry, Quality Assurance, Medical Devices, Biotechnology, Quality System, Root Cause Analysis, Process Improvement, CAPA, Training, FDA, HPLC, Validation, Sop, Quality Control, 21 CFR Part 11, Manufacturing, Change Control, Computer System..., V&V, Chromatography, Testing, SOP
Education
Arizona State University, IRA School of Engineering 2011 — 2011
Certified, Six Sigma Master Black Belt
Cedarville University 1996 — 2000
Bachelors, Chemistry
Indiana University School of Medicine
Graduate, Biotechnology Training Program
Gerry Achoki's Performance Validation Experience January 2013 - Present
Job Validation Engineer at Performance Validation
Industry Mechanical or Industrial Engineering
Experience
Performance Validation January 2013 - Present
United States Infrastructure Corp., Inc. (USIC) September 2011 - December 2011
Indiana University Health Arnett September 2011 - December 2011
FactSet Research Systems November 2009 - December 2009
Billboard September 2009 - December 2009
UNFPA June 2009 - August 2009
Skills
Process Improvement, Marketing, Quality System, Minitab, Validation, Quality Assurance, Six Sigma, Quality Control, GMP, Root Cause Analysis, FDA, Continuous Improvement, Equipment Qualification, Equipment Commissioning
Education
Purdue University
Bachelor of Science (B.S.), Industrial Engineering
Performance Validation January 2013 - Present
United States Infrastructure Corp., Inc. (USIC) September 2011 - December 2011
Indiana University Health Arnett September 2011 - December 2011
FactSet Research Systems November 2009 - December 2009
Billboard September 2009 - December 2009
UNFPA June 2009 - August 2009
Skills
Process Improvement, Marketing, Quality System, Minitab, Validation, Quality Assurance, Six Sigma, Quality Control, GMP, Root Cause Analysis, FDA, Continuous Improvement, Equipment Qualification, Equipment Commissioning
Education
Purdue University
Bachelor of Science (B.S.), Industrial Engineering
Tomasz Lewczyk Tomasz Lewczyk's Performance Validation Experience September 2014 - Present
Job Validation Engineer at Performance Validation
Industry Mechanical or Industrial Engineering
Experience
Performance Validation September 2014 - Present
Procter & Gamble April 2014 - July 2014
Marel Stork Poultry Processing B.V. May 2012 - November 2013
Praxair January 2011 - March 2011
IIMAK November 2009 - July 2010
University at Buffalo August 2008 - May 2009
Skills
General Software..., 3-D Modeling (AUTOCAD,..., Operating Systems..., Programming Languages..., Other Computer skills..., foreign languages..., Manufacturing, Solidworks, Mechanical Engineering, Lean Manufacturing, Pro Engineer, Engineering, Machining, Testing, Root Cause Analysis
Education
SUNY at Buffalo 2003 — 2009
Bachelor of Science (BS), Mechanical Engineering, 3.56
Performance Validation September 2014 - Present
Procter & Gamble April 2014 - July 2014
Marel Stork Poultry Processing B.V. May 2012 - November 2013
Praxair January 2011 - March 2011
IIMAK November 2009 - July 2010
University at Buffalo August 2008 - May 2009
Skills
General Software..., 3-D Modeling (AUTOCAD,..., Operating Systems..., Programming Languages..., Other Computer skills..., foreign languages..., Manufacturing, Solidworks, Mechanical Engineering, Lean Manufacturing, Pro Engineer, Engineering, Machining, Testing, Root Cause Analysis
Education
SUNY at Buffalo 2003 — 2009
Bachelor of Science (BS), Mechanical Engineering, 3.56
Jennifer Medcalf, MBA, PMP, LSSGB Jennifer Medcalf, MBA, PMP, LSSGB's Performance Validation Experience 1995 - 1996
Job R&D Project Manager (Portfolio Management) at PharmaForce Inc.
Industry Pharmaceuticals
Experience
PharmaForce Inc. March 2015 - Present
Abbott Nutrition June 2012 - March 2015
Nexeo Solutions, LLC April 2011 - May 2012
Ashland Inc. September 2007 - March 2011
Intranasal Therapeutics February 2007 - September 2007
Eli Lilly 2000 - 2007
Novo Nordisk 1999 - 2000
Cognis 1997 - 1999
Performance Validation 1995 - 1996
Hilton Davis 1993 - 1995
Education
Purdue University 2011 — 2011
Green Belt Certification
Indiana University - Kelley School of Business 2003 — 2006
MBA
University of Cincinnati 1992 — 1997
BS
PharmaForce Inc. March 2015 - Present
Abbott Nutrition June 2012 - March 2015
Nexeo Solutions, LLC April 2011 - May 2012
Ashland Inc. September 2007 - March 2011
Intranasal Therapeutics February 2007 - September 2007
Eli Lilly 2000 - 2007
Novo Nordisk 1999 - 2000
Cognis 1997 - 1999
Performance Validation 1995 - 1996
Hilton Davis 1993 - 1995
Education
Purdue University 2011 — 2011
Green Belt Certification
Indiana University - Kelley School of Business 2003 — 2006
MBA
University of Cincinnati 1992 — 1997
BS
Amy Kahanec Amy Kahanec's Performance Validation Experience June 2005 - November 2008
Job Quality Engineer at NSS
Industry Mining & Metals
Experience
NSS Technologies, Inc. August 2014 - Present
NSS Technologies, Inc. May 2014 - August 2014
Covidien February 2011 - January 2013
Covidien January 2009 - February 2011
Performance Validation June 2005 - November 2008
Pfizer 2005 - November 2008
Michigan State University June 2004 - June 2005
Skills
Validation, FDA, Medical Devices, GMP, V&V, CAPA, Quality System, 21 CFR Part 11, ISO 13485, SPC, Sop, Minitab, Design of Experiments, Six Sigma, Pharmaceutical Industry, FMEA, Computer System..., Design Control, Manufacturing Operations, Aseptic Processing, Lean Manufacturing, Supplier Quality, DMAIC, ISO 14971, Quality Control, Process Simulation, Quality Management, R&D, CQE, Quality Assurance, FDA GMP, GAMP, Root Cause Analysis, Manufacturing, Value Stream Mapping, Technology Transfer, Quality Auditing, Continuous Improvement, MS Project, Testing, Change Control, 21 CFR, ISO
Education
Michigan State University 2001 — 2005
BS, Chemical Engineering
NSS Technologies, Inc. August 2014 - Present
NSS Technologies, Inc. May 2014 - August 2014
Covidien February 2011 - January 2013
Covidien January 2009 - February 2011
Performance Validation June 2005 - November 2008
Pfizer 2005 - November 2008
Michigan State University June 2004 - June 2005
Skills
Validation, FDA, Medical Devices, GMP, V&V, CAPA, Quality System, 21 CFR Part 11, ISO 13485, SPC, Sop, Minitab, Design of Experiments, Six Sigma, Pharmaceutical Industry, FMEA, Computer System..., Design Control, Manufacturing Operations, Aseptic Processing, Lean Manufacturing, Supplier Quality, DMAIC, ISO 14971, Quality Control, Process Simulation, Quality Management, R&D, CQE, Quality Assurance, FDA GMP, GAMP, Root Cause Analysis, Manufacturing, Value Stream Mapping, Technology Transfer, Quality Auditing, Continuous Improvement, MS Project, Testing, Change Control, 21 CFR, ISO
Education
Michigan State University 2001 — 2005
BS, Chemical Engineering
William Waterstreet's Performance Validation Experience January 2015 - Present
Job Validation Engineer at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation January 2015 - Present
JS Vig Construction Company August 2014 - January 2015
JS Vig Construction Company May 2013 - August 2013
North American Lighting May 2010 - August 2010
North American Lighting June 2009 - August 2009
Wayne County Prosecutor's Office June 2007 - August 2007
Skills
Process Engineering, R&D, Solidworks, Matlab, MathCAD, NI LabVIEW, Report Writing, Microsoft Excel, Engineering Drawings, Catia, MS Project, Engineering, Testing, Aseptic Technique, Microsoft Office, Research
Education
Purdue University 2008 — 2014
Bachelor of Science (B.S.), Biological/Biosystems Engineering
Purdue University 2008 — 2014
Bachelor of Science (B.S.), Mechanical Engineering
Detroit Catholic Central High School 2004 — 2008
Performance Validation January 2015 - Present
JS Vig Construction Company August 2014 - January 2015
JS Vig Construction Company May 2013 - August 2013
North American Lighting May 2010 - August 2010
North American Lighting June 2009 - August 2009
Wayne County Prosecutor's Office June 2007 - August 2007
Skills
Process Engineering, R&D, Solidworks, Matlab, MathCAD, NI LabVIEW, Report Writing, Microsoft Excel, Engineering Drawings, Catia, MS Project, Engineering, Testing, Aseptic Technique, Microsoft Office, Research
Education
Purdue University 2008 — 2014
Bachelor of Science (B.S.), Biological/Biosystems Engineering
Purdue University 2008 — 2014
Bachelor of Science (B.S.), Mechanical Engineering
Detroit Catholic Central High School 2004 — 2008
Erol Ali Cetinok's Performance Validation Experience February 1995 - August 1996
Job Principal, Senior Consultant
Industry Biotechnology
Experience
SynerQ 2006 - Present
Zimmer 2014 - 2015
Atrium Medical/Maquet Getinge Group 2014 - 2014
Hill-Rom 2013 - 2013
EDS in partnership with Pearl Pathways 2013 - 2013
Indiana University - Medical and Molecular Genetics, Vector Production Facility July 2006 - 2013
Engineered Machined Products 2004 - 2006
Seat Tech, Inc. 2000 - 2004
Porter Engineered Systems 1997 - 2000
Performance Validation February 1995 - August 1996
Skills
Quality System, Process Improvement, Quality Assurance, Six Sigma, Continuous Improvement, Validation, Quality Auditing, FDA, Program Management, GMP, FMEA, SPC, Iso 9000, Manufacturing, ISO, Auditing, Internal Audit, Software Documentation, Project Planning, Budgets, Medical Devices, Sop, Business Process..., Quality Control, ISO 13485, Analysis, Biotechnology, Pharmaceutical Industry, CAPA, Quality Management, Engineering, Root Cause Analysis, Regulatory Affairs, Product Development, Technology Transfer, Cross-functional Team..., Project Management, Lean Manufacturing, DMAIC, 21 CFR Part 11, Process Engineering, Management, Process Simulation, SOP
Education
Purdue University
BSME, Mechanical Engineering
Indiana Unversity
BA, Political Science
SynerQ 2006 - Present
Zimmer 2014 - 2015
Atrium Medical/Maquet Getinge Group 2014 - 2014
Hill-Rom 2013 - 2013
EDS in partnership with Pearl Pathways 2013 - 2013
Indiana University - Medical and Molecular Genetics, Vector Production Facility July 2006 - 2013
Engineered Machined Products 2004 - 2006
Seat Tech, Inc. 2000 - 2004
Porter Engineered Systems 1997 - 2000
Performance Validation February 1995 - August 1996
Skills
Quality System, Process Improvement, Quality Assurance, Six Sigma, Continuous Improvement, Validation, Quality Auditing, FDA, Program Management, GMP, FMEA, SPC, Iso 9000, Manufacturing, ISO, Auditing, Internal Audit, Software Documentation, Project Planning, Budgets, Medical Devices, Sop, Business Process..., Quality Control, ISO 13485, Analysis, Biotechnology, Pharmaceutical Industry, CAPA, Quality Management, Engineering, Root Cause Analysis, Regulatory Affairs, Product Development, Technology Transfer, Cross-functional Team..., Project Management, Lean Manufacturing, DMAIC, 21 CFR Part 11, Process Engineering, Management, Process Simulation, SOP
Education
Purdue University
BSME, Mechanical Engineering
Indiana Unversity
BA, Political Science
John Frucci John Frucci's Performance Validation Experience 2001 - 2003
Job Associate Director, QA
Industry Pharmaceuticals
Experience
Gilead Sciences June 2015 - Present
Sandoz September 2011 - June 2015
Bayer HealthCare July 2008 - September 2011
Amgen July 2006 - July 2008
Martec, LLC December 2005 - August 2006
Pfizer 2005 - 2005
Perrigo Company 2003 - 2005
Performance Validation 2001 - 2003
Skills
Quality System, Validation, Quality Assurance, CAPA, FDA, Change Control, Process Improvement, Quality Control, Biotechnology, Manufacturing, Process Simulation, GMP, Sop, Pharmaceutical Industry, Management, 21 CFR Part 11, Computer System..., Software Documentation, Trackwise, Regulatory Affairs, Regulatory Requirements, GxP, Technology Transfer, Quality Auditing, Pharmaceutics, Biopharmaceuticals, Deviations, SOP, TrackWise
Education
Western Michigan University - Haworth College of Business 1999 — 2001
MPA, Public Administration
State University of New York College at Potsdam 1992 — 1996
BA, Interdisciplinary Natural Sciences, Secondary Education
Gilead Sciences June 2015 - Present
Sandoz September 2011 - June 2015
Bayer HealthCare July 2008 - September 2011
Amgen July 2006 - July 2008
Martec, LLC December 2005 - August 2006
Pfizer 2005 - 2005
Perrigo Company 2003 - 2005
Performance Validation 2001 - 2003
Skills
Quality System, Validation, Quality Assurance, CAPA, FDA, Change Control, Process Improvement, Quality Control, Biotechnology, Manufacturing, Process Simulation, GMP, Sop, Pharmaceutical Industry, Management, 21 CFR Part 11, Computer System..., Software Documentation, Trackwise, Regulatory Affairs, Regulatory Requirements, GxP, Technology Transfer, Quality Auditing, Pharmaceutics, Biopharmaceuticals, Deviations, SOP, TrackWise
Education
Western Michigan University - Haworth College of Business 1999 — 2001
MPA, Public Administration
State University of New York College at Potsdam 1992 — 1996
BA, Interdisciplinary Natural Sciences, Secondary Education
Julie Dorcey-Thompson, CQA Julie Dorcey-Thompson, CQA's Performance Validation Experience March 2001 - January 2003
Job Computer Validation Specialist at PAR Sterile Products
Industry Pharmaceuticals
Experience
PAR Sterile Products March 2013 - Present
Life Technologies October 2010 - March 2013
Zimmer August 2008 - October 2010
Bayer, Eli Lilly, Enzon, Roche April 2003 - June 2008
Performance Validation March 2001 - January 2003
Wyckoff Chemical Company December 1991 - December 2000
Skills
Microsoft Office, Minitab, SPC, SAP LMS, Mainsaver, E1, Oracle Agile, SAP HR, Trackwise, JD Edwards, Validation, FDA, Quality Assurance, Quality Control, Medical Devices, Quality System, Testing, Pharmaceutical Industry, Manufacturing, FMEA, 21 CFR Part 11, Change Control, GAMP, ISO 13485, CAPA, V&V, GMP, Computer System..., GxP, Sop, Quality Auditing, LIMS, SDLC, Design Control, Biotechnology, Technology Transfer, SOP
Education
Grand Valley State University 1986 — 1990
BS, Math/Statistics
Swan Valley High School 1981 — 1985
High School, College Prep
PAR Sterile Products March 2013 - Present
Life Technologies October 2010 - March 2013
Zimmer August 2008 - October 2010
Bayer, Eli Lilly, Enzon, Roche April 2003 - June 2008
Performance Validation March 2001 - January 2003
Wyckoff Chemical Company December 1991 - December 2000
Skills
Microsoft Office, Minitab, SPC, SAP LMS, Mainsaver, E1, Oracle Agile, SAP HR, Trackwise, JD Edwards, Validation, FDA, Quality Assurance, Quality Control, Medical Devices, Quality System, Testing, Pharmaceutical Industry, Manufacturing, FMEA, 21 CFR Part 11, Change Control, GAMP, ISO 13485, CAPA, V&V, GMP, Computer System..., GxP, Sop, Quality Auditing, LIMS, SDLC, Design Control, Biotechnology, Technology Transfer, SOP
Education
Grand Valley State University 1986 — 1990
BS, Math/Statistics
Swan Valley High School 1981 — 1985
High School, College Prep
Matthew Hopson's Performance Validation Experience August 2012 - Present
Job Validation Engineer at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation August 2012 - Present
Mead Johnson Nutrition December 2009 - December 2011
Skills
Process Engineering, Validation, Testing
Education
Purdue University 2005 — 2009
Bachelor of Science, Chemical Engineering
Performance Validation August 2012 - Present
Mead Johnson Nutrition December 2009 - December 2011
Skills
Process Engineering, Validation, Testing
Education
Purdue University 2005 — 2009
Bachelor of Science, Chemical Engineering
Jon Harrison Jon Harrison's Performance Validation Experience May 2003 - November 2005
Job Senior Validation Engineering Contractor at Terumo Cardiovascular Systems
Industry Internet
Experience
Compliance Team Inc. May 2012 - May 2014
Independent Contractor March 2011 - March 2012
cGMP Validation January 2008 - November 2010
Independent Contractor December 2006 - December 2007
Performance Validation May 2003 - November 2005
L'Oreal USA May 1997 - January 2003
Skills
Validation, GMP, Quality System, V&V, Quality Assurance, CAPA, Computer System..., Engineering, FDA, ISO 13485, Inspection, Lean Manufacturing, Medical Devices, Quality Auditing, Quality Control, Root Cause Analysis, SOP, Sop, V
Education
Clemson University
Bachelor of Science (BS), Mechanical Engineering
Compliance Team Inc. May 2012 - May 2014
Independent Contractor March 2011 - March 2012
cGMP Validation January 2008 - November 2010
Independent Contractor December 2006 - December 2007
Performance Validation May 2003 - November 2005
L'Oreal USA May 1997 - January 2003
Skills
Validation, GMP, Quality System, V&V, Quality Assurance, CAPA, Computer System..., Engineering, FDA, ISO 13485, Inspection, Lean Manufacturing, Medical Devices, Quality Auditing, Quality Control, Root Cause Analysis, SOP, Sop, V
Education
Clemson University
Bachelor of Science (BS), Mechanical Engineering
Dean Priebe Dean Priebe's Performance Validation Experience October 1995 - October 1997
Job Director, Simultaneous & Partnered Engineering (SPE)
Industry Logistics and Supply Chain
Experience
C&S Wholesale Grocers April 2014 - Present
C&S Wholesale Grocers August 2013 - April 2014
Smiths Medical October 2011 - May 2013
NNE Pharmaplan March 2010 - October 2011
International Society for Pharmaceutical Engineers 1997 - 2011
Covidien April 2007 - March 2010
Novartis March 2000 - April 2007
Commissioning Agents, Inc October 1997 - March 2000
Performance Validation October 1995 - October 1997
US Navy October 1989 - October 1995
Skills
Safety Management..., FDA GMP, Operations Management, Program Management, Project Management, Operational Excellence, Lean Thinking, Change Management, Development & delivery..., Pharmaceutical Industry, Medical Devices, GMP, FDA, Six Sigma, Process Improvement, Lean Manufacturing, Cross-functional Team..., Training, Engineering, Software Documentation, CAPA, Root Cause Analysis, Value Stream Mapping, Quality System, Continuous Improvement, ISO 13485, Validation, Management, Manufacturing, V&V, 21 CFR Part 11, Quality Assurance, DMAIC, Leadership, ISO, Design of Experiments, Change Control, Quality Management, Computer System..., Product Development, Quality Control, Sop, Design Control, Process Engineering, Biotechnology, R&D, Quality Auditing, SPC, Technology Transfer, Process Simulation
Education
The University of Connecticut School of Business 2004 — 2006
Masters, MBA
Thomas Edison State College 2003 — 2004
BS, Nuclear Engineering
Southern Illinois University, Carbondale 2001 — 2004
BS AST, Workforce Education, Training, and Development
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
Patricia Stewart Flaherty, M.Sc Patricia Stewart Flaherty, M.Sc's Performance Validation Experience 2001 - 2005
Job Vice President, Compliance Concepts International & ISPE San Diego Chapter President
Industry Biotechnology
Experience
Compliance Concepts International March 2005 - Present
Department of Health and Human Services September 2008 - May 2012
Spectrum Pharmaceuticals February 2007 - December 2008
... January 1980 - January 2008
Performance Validation 2001 - 2005
Bayer 1999 - 2001
Aventis GmbH 1996 - 1999
Centeon Pharma 1996 - 1999
Aker Kvaerner (John Brown) 1993 - 1996
Fluor Daniel 1991 - 1993
Skills
FDA, Pharmaceutical Industry, GMP, Biotechnology, Validation, Technology Transfer, Regulatory Affairs, Medical Devices, Lifesciences, Quality Assurance, Quality System, Computer System..., Sop, CAPA, Project Management, V&V, Change Control, Vaccines, GxP, Strategic Planning, Biopharmaceuticals
Education
Northeastern University 2007 — 2009
M.S., Regulatory Affairs
University of Phoenix 1999 — 2003
B.S. Business Management
Compliance Concepts International March 2005 - Present
Department of Health and Human Services September 2008 - May 2012
Spectrum Pharmaceuticals February 2007 - December 2008
... January 1980 - January 2008
Performance Validation 2001 - 2005
Bayer 1999 - 2001
Aventis GmbH 1996 - 1999
Centeon Pharma 1996 - 1999
Aker Kvaerner (John Brown) 1993 - 1996
Fluor Daniel 1991 - 1993
Skills
FDA, Pharmaceutical Industry, GMP, Biotechnology, Validation, Technology Transfer, Regulatory Affairs, Medical Devices, Lifesciences, Quality Assurance, Quality System, Computer System..., Sop, CAPA, Project Management, V&V, Change Control, Vaccines, GxP, Strategic Planning, Biopharmaceuticals
Education
Northeastern University 2007 — 2009
M.S., Regulatory Affairs
University of Phoenix 1999 — 2003
B.S. Business Management
Gerald Hodge Gerald Hodge's Performance Validation Experience March 2001 - January 2003
Job President & CEO of GH Pharma Network LLC (hodgegr@gmail.com)
Industry Pharmaceuticals
Experience
GH - Pharma Network LLC September 2006 - Present
nne August 2005 - August 2006
Wyeth February 2003 - August 2005
Performance Validation March 2001 - January 2003
Day and Zimmermann International Inc. 1999 - 2001
Olsten Staffing 1998 - 1999
Skills
Packaging, Commercialization, Validation, USP, Project Management, Team Management, GMP, 21 CFR Part 11, FDA, Change Control, CAPA, Sop, Pharmaceutical Industry, Biotechnology, Quality System, Technology Transfer, Quality Assurance, Lifesciences, GLP, Quality Auditing, Vaccines, Quality Management, Manufacturing, LIMS, Software Documentation, Biopharmaceuticals, V&V, Aseptic Processing, Laboratory, Product Development, Computer System..., GAMP, Pharmaceutics, Life Sciences
Education
Francis Marion University 1993 — 1998
BS, Biology
Francis Marion University
Bachelor of Science (BS), Biology/Biological Sciences, General
GH - Pharma Network LLC September 2006 - Present
nne August 2005 - August 2006
Wyeth February 2003 - August 2005
Performance Validation March 2001 - January 2003
Day and Zimmermann International Inc. 1999 - 2001
Olsten Staffing 1998 - 1999
Skills
Packaging, Commercialization, Validation, USP, Project Management, Team Management, GMP, 21 CFR Part 11, FDA, Change Control, CAPA, Sop, Pharmaceutical Industry, Biotechnology, Quality System, Technology Transfer, Quality Assurance, Lifesciences, GLP, Quality Auditing, Vaccines, Quality Management, Manufacturing, LIMS, Software Documentation, Biopharmaceuticals, V&V, Aseptic Processing, Laboratory, Product Development, Computer System..., GAMP, Pharmaceutics, Life Sciences
Education
Francis Marion University 1993 — 1998
BS, Biology
Francis Marion University
Bachelor of Science (BS), Biology/Biological Sciences, General
Luke Stark's Performance Validation Experience June 2005 - January 2014
Job Quality Engineer at Living Essentials, LLC
Industry Pharmaceuticals
Experience
Technicolor March 2015 - Present
Living Essentials January 2014 - March 2015
Performance Validation June 2005 - January 2014
Eli Lilly and Company 2005 - January 2014
Rose-Hulman Institute of Technology 2001 - May 2005
Skills
CQA, Pharmaceutical Industry, Validation, FDA, GMP, CAPA, Medical Devices, Quality Assurance, 21 CFR Part 11, Quality System, Process Improvement, Technical Writing, Sop, Continuous Improvement, Lean Manufacturing, Root Cause Analysis, Manufacturing, Quality Management, CQE, Leadership, Computer System..., Change Control, Testing, GAMP, GxP, Cleaning Validation, ISO 13485, SOP
Education
Rose-Hulman Institute of Technology 2001 — 2005
Computer Engineering
Technicolor March 2015 - Present
Living Essentials January 2014 - March 2015
Performance Validation June 2005 - January 2014
Eli Lilly and Company 2005 - January 2014
Rose-Hulman Institute of Technology 2001 - May 2005
Skills
CQA, Pharmaceutical Industry, Validation, FDA, GMP, CAPA, Medical Devices, Quality Assurance, 21 CFR Part 11, Quality System, Process Improvement, Technical Writing, Sop, Continuous Improvement, Lean Manufacturing, Root Cause Analysis, Manufacturing, Quality Management, CQE, Leadership, Computer System..., Change Control, Testing, GAMP, GxP, Cleaning Validation, ISO 13485, SOP
Education
Rose-Hulman Institute of Technology 2001 — 2005
Computer Engineering
Daniel Oman Daniel Oman's Performance Validation Experience July 2010 - Present
Job Validation Specialist at Performance Validation LLC
Industry Information Services
Experience
Performance Validation July 2010 - Present
Precision Control Integrators February 2010 - July 2010
Performance Validation 2007 - 2009
Pfizer Pharmaceuticals 2001 - 2007
Parker Aerospace 1998 - 2001
Parker Hannifin August 1993 - August 1998
Burns International Security Services June 1990 - July 1993
US Army January 1987 - May 1990
Skills
Validation, Computer System..., 21 CFR Part 11, GAMP, FDA, SOP, Documentation, Testing, Document Management, Technical Writing, Software Validation, Change Control, Sop, GxP, Automation, Software Documentation, GMP, V&V, Quality System, Regulatory Affairs, Process Simulation, Medical Devices, Technology Transfer, Biotechnology, Pharmaceutical Industry, Quality Assurance, Root Cause Analysis, ISO 13485, Aseptic Processing, FDA GMP, Lifesciences, Trackwise, Continuous Improvement, CSV
Education
Kalamazoo Valley Community College 1991 — 2001
Associate of Arts, Liberal Arts (Communications)
Performance Validation July 2010 - Present
Precision Control Integrators February 2010 - July 2010
Performance Validation 2007 - 2009
Pfizer Pharmaceuticals 2001 - 2007
Parker Aerospace 1998 - 2001
Parker Hannifin August 1993 - August 1998
Burns International Security Services June 1990 - July 1993
US Army January 1987 - May 1990
Skills
Validation, Computer System..., 21 CFR Part 11, GAMP, FDA, SOP, Documentation, Testing, Document Management, Technical Writing, Software Validation, Change Control, Sop, GxP, Automation, Software Documentation, GMP, V&V, Quality System, Regulatory Affairs, Process Simulation, Medical Devices, Technology Transfer, Biotechnology, Pharmaceutical Industry, Quality Assurance, Root Cause Analysis, ISO 13485, Aseptic Processing, FDA GMP, Lifesciences, Trackwise, Continuous Improvement, CSV
Education
Kalamazoo Valley Community College 1991 — 2001
Associate of Arts, Liberal Arts (Communications)
Nick Fava Nick Fava's Performance Validation Experience July 1998 - September 2001
Job Senior Director, Quality Department at Ash Stevens Inc.
Industry Pharmaceuticals
Experience
Ash Stevens Inc. April 2014 - Present
Ash Stevens Inc. May 2013 - March 2014
Ash Stevens Inc. January 2012 - May 2013
Merck January 2009 - January 2012
Schering-Plough Research Institute November 2005 - January 2009
Pfizer September 2001 - November 2005
Performance Validation July 1998 - September 2001
Vectech Pharmaceutical Consultants June 1996 - July 1998
Skills
Validation, Quality Assurance, Equipment Qualification, Auditing, SOP development, Commissioning, Warehousing, GMP, Computer System..., Pharmaceutical Industry, Change Control, FDA, Quality Control, Root Cause Analysis, Quality Auditing, V&V, CAPA, Sop, Software Documentation, Manufacturing, SOP, SOP Development, Cross-functional Team..., Project Management, Facility Start-up, Quality System, 21 CFR Part 11
Education
Stevens Institute of Technology 2008 — 2014
Master of Science, Pharmaceutical Manufacturing
Michigan State University 1993 — 1996
BS, College of Science
Oakland Community College 1991 — 1993
Assoc in Science, Science
Ash Stevens Inc. April 2014 - Present
Ash Stevens Inc. May 2013 - March 2014
Ash Stevens Inc. January 2012 - May 2013
Merck January 2009 - January 2012
Schering-Plough Research Institute November 2005 - January 2009
Pfizer September 2001 - November 2005
Performance Validation July 1998 - September 2001
Vectech Pharmaceutical Consultants June 1996 - July 1998
Skills
Validation, Quality Assurance, Equipment Qualification, Auditing, SOP development, Commissioning, Warehousing, GMP, Computer System..., Pharmaceutical Industry, Change Control, FDA, Quality Control, Root Cause Analysis, Quality Auditing, V&V, CAPA, Sop, Software Documentation, Manufacturing, SOP, SOP Development, Cross-functional Team..., Project Management, Facility Start-up, Quality System, 21 CFR Part 11
Education
Stevens Institute of Technology 2008 — 2014
Master of Science, Pharmaceutical Manufacturing
Michigan State University 1993 — 1996
BS, College of Science
Oakland Community College 1991 — 1993
Assoc in Science, Science
Garth Smitman Garth Smitman's Performance Validation Experience November 2008 - August 2011
Job Calm and Relentless Expert
Industry Medical Devices
Experience
Meggitt Piezo Technologies August 2014 - Present
MAETRICS April 2014 - January 2015
Maetrics, LLC December 2013 - December 2014
King Systems December 2013 - June 2014
G&H Wire August 2011 - December 2013
Performance Validation November 2008 - August 2011
American Society for Quality 2005 - August 2011
Performance Validation June 2001 - August 2011
Performance Validation June 2001 - August 2011
Toastmasters International April 2008 - June 2010
Skills
Quality System, Continuous Improvement, Quality Management, Quality Assurance, Quality Control, Validation, GMP, PMP, Six Sigma, Quality Auditing, CQA, ISO 13485, Root Cause Analysis, CAPA, Process Engineering, Microsoft Office, V&V, Process Improvement, DMAIC, Change Control, Manufacturing, Software Documentation, Medical Devices, Training, FDA, SPC, Leadership, Management, Supplier Quality, Employee Training, Computer System..., Program Management, Project Planning, 21 CFR Part 11, Cross-functional Team..., Public Speaking, ISO, Lean Manufacturing, Operational Excellence, TQM, Pharmaceutical Industry
Education
Purdue University 1998 — 2001
BS, Chemical Engineering
Montana State University-Billings 1996 — 1998
hours towards BS, Chemistry
Harlem High School 1984 — 1988
HS Diploma, College Prep
Meggitt Piezo Technologies August 2014 - Present
MAETRICS April 2014 - January 2015
Maetrics, LLC December 2013 - December 2014
King Systems December 2013 - June 2014
G&H Wire August 2011 - December 2013
Performance Validation November 2008 - August 2011
American Society for Quality 2005 - August 2011
Performance Validation June 2001 - August 2011
Performance Validation June 2001 - August 2011
Toastmasters International April 2008 - June 2010
Skills
Quality System, Continuous Improvement, Quality Management, Quality Assurance, Quality Control, Validation, GMP, PMP, Six Sigma, Quality Auditing, CQA, ISO 13485, Root Cause Analysis, CAPA, Process Engineering, Microsoft Office, V&V, Process Improvement, DMAIC, Change Control, Manufacturing, Software Documentation, Medical Devices, Training, FDA, SPC, Leadership, Management, Supplier Quality, Employee Training, Computer System..., Program Management, Project Planning, 21 CFR Part 11, Cross-functional Team..., Public Speaking, ISO, Lean Manufacturing, Operational Excellence, TQM, Pharmaceutical Industry
Education
Purdue University 1998 — 2001
BS, Chemical Engineering
Montana State University-Billings 1996 — 1998
hours towards BS, Chemistry
Harlem High School 1984 — 1988
HS Diploma, College Prep
Glenn Odle Glenn Odle's Performance Validation Experience January 2002 - March 2005
Job Sr. Validation Engineer II at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals August 2010 - Present
Shire Pharmaceuticals 2005 - 2011
Shire Pharmaceuticals 2005 - 2011
Shire March 2007 - August 2010
Shire Pharmaceuticals March 2005 - March 2007
Performance Validation January 2002 - March 2005
Education
University of Cincinnati 1989 — 1989
Certification, Temperature studies
Shire Pharmaceuticals August 2010 - Present
Shire Pharmaceuticals 2005 - 2011
Shire Pharmaceuticals 2005 - 2011
Shire March 2007 - August 2010
Shire Pharmaceuticals March 2005 - March 2007
Performance Validation January 2002 - March 2005
Education
University of Cincinnati 1989 — 1989
Certification, Temperature studies
Jacob Haynes's Performance Validation Experience September 2006 - January 2015
Job Manager, QA Validation at Kremers Urban Pharmaceuticals
Industry Pharmaceuticals
Experience
Kremers Urban Pharmaceuticals Inc. January 2015 - Present
Performance Validation September 2006 - January 2015
Patriot Engineering and Environmental, Inc. May 2005 - August 2005
Skills
GMP, Validation, FDA, Change Control, Computer System..., Manufacturing, Pharmaceutics, CAPA, Project Management, SOP, CQA, 21 CFR Part 11, Commissioning, Pharmaceutical Industry, CAPM, GAMP, Quality Assurance, CQE
Education
Purdue University 2002 — 2006
Mechanical Engineering
Kremers Urban Pharmaceuticals Inc. January 2015 - Present
Performance Validation September 2006 - January 2015
Patriot Engineering and Environmental, Inc. May 2005 - August 2005
Skills
GMP, Validation, FDA, Change Control, Computer System..., Manufacturing, Pharmaceutics, CAPA, Project Management, SOP, CQA, 21 CFR Part 11, Commissioning, Pharmaceutical Industry, CAPM, GAMP, Quality Assurance, CQE
Education
Purdue University 2002 — 2006
Mechanical Engineering
Hugh Ray Hugh Ray's Performance Validation Experience June 2011 - January 2013
Job Research and Development Technician at Club Car
Industry Automotive
Experience
Club Car July 2013 - Present
Performance Validation June 2011 - January 2013
R.E. Phelon June 2006 - February 2009
Phelon Motorsports October 1996 - June 2006
Indy Racing League 2004 - 2006
United States Air force 1987 - 1996
Skills
Validation, Engineering, FMEA, Testing, Manufacturing, Quality Control, V&V, Continuous Improvement, Six Sigma, Inspection, Purchasing, Lean Manufacturing, Root Cause Analysis, Quality System, Software Documentation, Manufacturing...
Education
Augusta Technnical College
Mechanical Engineering Technology, Mechanical Engineering
Community College of the Air Force
Metals Technology, Non Destictive Inspection
Club Car July 2013 - Present
Performance Validation June 2011 - January 2013
R.E. Phelon June 2006 - February 2009
Phelon Motorsports October 1996 - June 2006
Indy Racing League 2004 - 2006
United States Air force 1987 - 1996
Skills
Validation, Engineering, FMEA, Testing, Manufacturing, Quality Control, V&V, Continuous Improvement, Six Sigma, Inspection, Purchasing, Lean Manufacturing, Root Cause Analysis, Quality System, Software Documentation, Manufacturing...
Education
Augusta Technnical College
Mechanical Engineering Technology, Mechanical Engineering
Community College of the Air Force
Metals Technology, Non Destictive Inspection
Chad Stringer's Performance Validation Experience May 2007 - December 2008
Job Practice Group Manager at EMA, Inc.
Industry Information Technology and Services
Experience
EMA, Inc. February 2013 - Present
EMA, Inc May 2012 - February 2013
Practive Solutions, Inc. December 2008 - May 2012
Performance Validation May 2007 - December 2008
Brock Solutions July 2006 - March 2007
Rockwell Automation December 1999 - June 2006
Compaq April 1999 - December 1999
Kirby Risk October 1997 - March 1999
Galyans Trading Company September 1991 - February 1999
Skills
Maximo, Oracle SQL, SQL Server, VMware, Hyper-V, Microsoft Servers, Databases, Data Analysis, Microsoft Office, Asset Management, Microsoft SQL Server, Automation, SQL, Asset Managment, Maintenance Management, Computer System..., Software Documentation, IT Asset Management, Validation, MS Project, Root Cause Analysis, Integration, Visio, System Deployment, Reliability Engineering, GAMP, Preventive Maintenance, Plant Maintenance, Websphere, Maintenance & Repair, Troubleshooting, Architecture Management, Business Analysis, Business Process, CMMS, Process Engineering, Requirements Analysis, Data Modeling, Manufacturing, SAP, Testing, Analysis, Microsoft Project, Process Improvement
Education
Purdue University 1995 — 1997
AS, Electrical Engineering Technology
Indiana University-Purdue University at Indianapolis 1991 — 1997
BA, Computer Science / Communications
EMA, Inc. February 2013 - Present
EMA, Inc May 2012 - February 2013
Practive Solutions, Inc. December 2008 - May 2012
Performance Validation May 2007 - December 2008
Brock Solutions July 2006 - March 2007
Rockwell Automation December 1999 - June 2006
Compaq April 1999 - December 1999
Kirby Risk October 1997 - March 1999
Galyans Trading Company September 1991 - February 1999
Skills
Maximo, Oracle SQL, SQL Server, VMware, Hyper-V, Microsoft Servers, Databases, Data Analysis, Microsoft Office, Asset Management, Microsoft SQL Server, Automation, SQL, Asset Managment, Maintenance Management, Computer System..., Software Documentation, IT Asset Management, Validation, MS Project, Root Cause Analysis, Integration, Visio, System Deployment, Reliability Engineering, GAMP, Preventive Maintenance, Plant Maintenance, Websphere, Maintenance & Repair, Troubleshooting, Architecture Management, Business Analysis, Business Process, CMMS, Process Engineering, Requirements Analysis, Data Modeling, Manufacturing, SAP, Testing, Analysis, Microsoft Project, Process Improvement
Education
Purdue University 1995 — 1997
AS, Electrical Engineering Technology
Indiana University-Purdue University at Indianapolis 1991 — 1997
BA, Computer Science / Communications
Dalton Pierson's Performance Validation Experience January 2006 - Present
Job Senior Validation Specialist/Project Leader at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation January 2006 - Present
IT&E International October 2004 - January 2006
QVM Services January 2002 - October 2004
Cryovac 2000 - 2002
CTC Analyticical Services 1997 - 2000
Skills
Commissioning, Validation, Auditing, Technical Writing, Medical Devices, FDA, Quality Systems, ISO 13485, GMP, Pharmaceuticals, Process Validation, cGMP, Quality System, V&V, Change Control, 21 CFR Part 11, CAPA, GAMP, Computer System..., Project Management, Verification, Pharmaceutical Industry, Airflow
Education
The University of Kansas 1992 — 1997
Bachelors, Biology
Performance Validation January 2006 - Present
IT&E International October 2004 - January 2006
QVM Services January 2002 - October 2004
Cryovac 2000 - 2002
CTC Analyticical Services 1997 - 2000
Skills
Commissioning, Validation, Auditing, Technical Writing, Medical Devices, FDA, Quality Systems, ISO 13485, GMP, Pharmaceuticals, Process Validation, cGMP, Quality System, V&V, Change Control, 21 CFR Part 11, CAPA, GAMP, Computer System..., Project Management, Verification, Pharmaceutical Industry, Airflow
Education
The University of Kansas 1992 — 1997
Bachelors, Biology
Jennifer Pint's Performance Validation Experience September 2011 - October 2014
Job Validation Specialist at Kremers Urban Pharmaceuticals
Industry Pharmaceuticals
Experience
Kremers Urban Pharmaceuticals October 2014 - Present
Performance Validation September 2011 - October 2014
Skills
Validation, 21 CFR Part 11, FDA, GMP, GxP, Equipment Qualification, Quality Assurance, CAPA
Education
Rose-Hulman Institute of Technology 2005 — 2009
Bachelor of Science (B.S.), Mechanical Engineering
Kremers Urban Pharmaceuticals October 2014 - Present
Performance Validation September 2011 - October 2014
Skills
Validation, 21 CFR Part 11, FDA, GMP, GxP, Equipment Qualification, Quality Assurance, CAPA
Education
Rose-Hulman Institute of Technology 2005 — 2009
Bachelor of Science (B.S.), Mechanical Engineering
Rick Van Doel Rick Van Doel's Performance Validation Experience 2006 - Present
Job President Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation 2006 - Present
Performance Validation 1997 - 2006
Performance Validation 1993 - 1997
US Navy 1972 - 1993
Skills
Validation, FDA, Medical Devices, Pharmaceutical Industry, GMP, 21 CFR Part 11, V&V, Change Control, Sop, CAPA, Quality System, Biotechnology, Quality Assurance, Regulatory Affairs, Computer System..., Cross-functional Team..., Technology Transfer, Cleaning Validation, GLP, Six Sigma, Biopharmaceuticals, Continuous Improvement, Lifesciences, Quality Control, Quality Auditing, ISO 13485, Root Cause Analysis, Quality Management, SOP
Education
Indiana Wesleyan University 2011 — 2017
Doctor of Philosophy (Ph.D.), Organizational Leadership
Indiana Wesleyan University 2009 — 2010
MSM, Management, 3.98
Indiana Wesleyan University 2007 — 2008
BS, Management, 4.0
Excelsior College 1979 — 1981
AS, General Studies
Performance Validation 2006 - Present
Performance Validation 1997 - 2006
Performance Validation 1993 - 1997
US Navy 1972 - 1993
Skills
Validation, FDA, Medical Devices, Pharmaceutical Industry, GMP, 21 CFR Part 11, V&V, Change Control, Sop, CAPA, Quality System, Biotechnology, Quality Assurance, Regulatory Affairs, Computer System..., Cross-functional Team..., Technology Transfer, Cleaning Validation, GLP, Six Sigma, Biopharmaceuticals, Continuous Improvement, Lifesciences, Quality Control, Quality Auditing, ISO 13485, Root Cause Analysis, Quality Management, SOP
Education
Indiana Wesleyan University 2011 — 2017
Doctor of Philosophy (Ph.D.), Organizational Leadership
Indiana Wesleyan University 2009 — 2010
MSM, Management, 3.98
Indiana Wesleyan University 2007 — 2008
BS, Management, 4.0
Excelsior College 1979 — 1981
AS, General Studies
Jarod Markley, EIT's Performance Validation Experience August 2010 - January 2012
Job Project Engineer at Becton Dickinson
Industry Medical Devices
Experience
BD July 2014 - Present
CSL Behring January 2012 - July 2014
Performance Validation August 2010 - January 2012
Axess Ultrasound June 2009 - September 2009
International Human Cadaver Prosection Program, IUN June 2009 - August 2009
Boston Scientific June 2008 - September 2008
Skills
Validation, Medical Devices, Pharmaceutical Industry, Aseptic Processing, Sterilization, cGMP practices, Engineering, Quality System, Change Control, Minitab, Biomedical Engineering, Pharmaceuticals, Orthopedics, Prosthetics, Mimics, Medical Imaging, Isolators, Autoclave, GMP, Equipment Qualification, Biopharmaceuticals, Regulatory Requirements, Quality Assurance, Trackwise, Aseptic Technique, 21 CFR
Education
Rose-Hulman Institute of Technology 2006 — 2010
Bachelor of Science, Biomedical Engineering, Biomechanics
BD July 2014 - Present
CSL Behring January 2012 - July 2014
Performance Validation August 2010 - January 2012
Axess Ultrasound June 2009 - September 2009
International Human Cadaver Prosection Program, IUN June 2009 - August 2009
Boston Scientific June 2008 - September 2008
Skills
Validation, Medical Devices, Pharmaceutical Industry, Aseptic Processing, Sterilization, cGMP practices, Engineering, Quality System, Change Control, Minitab, Biomedical Engineering, Pharmaceuticals, Orthopedics, Prosthetics, Mimics, Medical Imaging, Isolators, Autoclave, GMP, Equipment Qualification, Biopharmaceuticals, Regulatory Requirements, Quality Assurance, Trackwise, Aseptic Technique, 21 CFR
Education
Rose-Hulman Institute of Technology 2006 — 2010
Bachelor of Science, Biomedical Engineering, Biomechanics
Daniel Kaczka Daniel Kaczka's Performance Validation Experience August 1999 - July 2004
Job Validation Manager at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca February 2014 - Present
Bristol-Myers Squibb October 2013 - February 2014
Bristol-Myers Squibb March 2012 - October 2013
Amylin Pharmaceuticals July 2007 - March 2012
Pfizer 2004 - 2007
Performance Validation August 1999 - July 2004
United States Navy January 1988 - July 1999
Skills
Process Validation, Computer System..., Automation Validation, Equipment Validation, Change Management, Regulatory Audits, Project Management, User Requirements, Design Specifications, Validation Plans, V&V, Pharmaceutical Industry, GMP, SOP development, 21 CFR Part 11, Cleaning Validation, Quality Control, Quality Assurance, Laboratory Equipment, Quality System, GAMP, GxP, Aseptic Processing, CAPA, Sop, FDA, Sterilization, Calibration, Cross-functional Team..., Quality Auditing, Root Cause Analysis, Validation, SOP
Education
Southern Illinois University, Carbondale 1996 — 1998
BS, Electronics Management
Western Reserve High School 1984 — 1987
Western Reserve High School 1983 — 1987
AstraZeneca February 2014 - Present
Bristol-Myers Squibb October 2013 - February 2014
Bristol-Myers Squibb March 2012 - October 2013
Amylin Pharmaceuticals July 2007 - March 2012
Pfizer 2004 - 2007
Performance Validation August 1999 - July 2004
United States Navy January 1988 - July 1999
Skills
Process Validation, Computer System..., Automation Validation, Equipment Validation, Change Management, Regulatory Audits, Project Management, User Requirements, Design Specifications, Validation Plans, V&V, Pharmaceutical Industry, GMP, SOP development, 21 CFR Part 11, Cleaning Validation, Quality Control, Quality Assurance, Laboratory Equipment, Quality System, GAMP, GxP, Aseptic Processing, CAPA, Sop, FDA, Sterilization, Calibration, Cross-functional Team..., Quality Auditing, Root Cause Analysis, Validation, SOP
Education
Southern Illinois University, Carbondale 1996 — 1998
BS, Electronics Management
Western Reserve High School 1984 — 1987
Western Reserve High School 1983 — 1987
Andrew Riddle Andrew Riddle's Performance Validation Experience January 2014 - Present
Job Staff Validation Engineer at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation January 2014 - Present
Georgia Institute of Technology May 2002 - January 2007
Skills
Customer Service, Energy, Factory, GMP, Inventory Management, Merchandising, Microsoft Excel, Microsoft Office, Retail, Sales, Time Management, Continuous Improvement, Team Building, Leadership, Engineering, Cross-functional Team..., Manufacturing
Education
Georgia Institute of Technology
BS, Chemical and Biomolecular Engineering
Georgia Institute of Technology
Certificate, Entrepreneurship/Entrepreneurial Studies
Performance Validation January 2014 - Present
Georgia Institute of Technology May 2002 - January 2007
Skills
Customer Service, Energy, Factory, GMP, Inventory Management, Merchandising, Microsoft Excel, Microsoft Office, Retail, Sales, Time Management, Continuous Improvement, Team Building, Leadership, Engineering, Cross-functional Team..., Manufacturing
Education
Georgia Institute of Technology
BS, Chemical and Biomolecular Engineering
Georgia Institute of Technology
Certificate, Entrepreneurship/Entrepreneurial Studies
Ross J. Burns's Performance Validation Experience June 2014 - August 2014
Job Staff Auditor at Blue & Co., LLC
Industry Accounting
Experience
Blue & Co., LLC September 2015 - Present
Performance Validation June 2014 - August 2014
Delta Sigma Pi - Alpha Pi Chapter (Indiana University) May 2013 - August 2014
Grant Thornton LLP May 2013 - August 2013
Student Accounting Society August 2010 - May 2013
Delta Sigma Pi - Alpha Pi Chapter (Indiana University) April 2012 - December 2012
Brownsburg Little League April 2006 - August 2012
Ernst & Young July 2012 - July 2012
Indianapolis Umpires Association April 2012 - July 2012
Skills
Analytical Knowledge, Interpersonal..., Microsoft Excel, Organization, Strategic Planning, Public Speaking, Management, Event Management, Coaching, Marketing, Finance, Budgets, Leadership, Financial Analysis
Education
Indiana University - Kelley School of Business 2014 — 2015
Master of Science in Accounting, Accounting, Graduate Student
Indiana University - Kelley School of Business 2010 — 2014
Bachelor of Science (BS), Accounting and Technology Management, Graduated
Blue & Co., LLC September 2015 - Present
Performance Validation June 2014 - August 2014
Delta Sigma Pi - Alpha Pi Chapter (Indiana University) May 2013 - August 2014
Grant Thornton LLP May 2013 - August 2013
Student Accounting Society August 2010 - May 2013
Delta Sigma Pi - Alpha Pi Chapter (Indiana University) April 2012 - December 2012
Brownsburg Little League April 2006 - August 2012
Ernst & Young July 2012 - July 2012
Indianapolis Umpires Association April 2012 - July 2012
Skills
Analytical Knowledge, Interpersonal..., Microsoft Excel, Organization, Strategic Planning, Public Speaking, Management, Event Management, Coaching, Marketing, Finance, Budgets, Leadership, Financial Analysis
Education
Indiana University - Kelley School of Business 2014 — 2015
Master of Science in Accounting, Accounting, Graduate Student
Indiana University - Kelley School of Business 2010 — 2014
Bachelor of Science (BS), Accounting and Technology Management, Graduated
Ryan Cargill Ryan Cargill's Performance Validation Experience November 2013 - August 2015
Job Manufacturing Engineer at Vention Medical
Industry Medical Devices
Experience
Vention Medical August 2015 - Present
Performance Validation November 2013 - August 2015
Vention Medical, Inc. April 2011 - July 2013
Behr October 2010 - January 2011
Skills
Engineering..., Microsoft Office, Team-oriented, Resourceful..., Minitab, Equipment Commissioning, Equipment Qualification, Continuous Improvement, Testing, SolidWorks
Education
Kettering University 2009 — 2013
Bachelor of Science (BS), Mechanical Engineering/Bioengineering Specialty
Vention Medical August 2015 - Present
Performance Validation November 2013 - August 2015
Vention Medical, Inc. April 2011 - July 2013
Behr October 2010 - January 2011
Skills
Engineering..., Microsoft Office, Team-oriented, Resourceful..., Minitab, Equipment Commissioning, Equipment Qualification, Continuous Improvement, Testing, SolidWorks
Education
Kettering University 2009 — 2013
Bachelor of Science (BS), Mechanical Engineering/Bioengineering Specialty
Kevin Marcial Kevin Marcial's Performance Validation Experience September 2011 - Present
Job Senior Validation Specialist at Performance Validation
Industry Information Technology and Services
Experience
Performance Validation September 2011 - Present
Performance Validation September 2011 - July 2012
MPI Research November 2006 - September 2011
Skills
Computer System..., GMP, FDA GMP, GLP, Validation, Instrument Validation, Pharmaceutical Industry, Medical Devices, HPLC, Management, Project Management, GxP, 21 CFR Part 11, FDA, Software Documentation, LIMS, CRO, Testing, Sop, Change Control, V&V, Laboratory, Quality System, Quality Control, CAPA, Regulatory Affairs, Quality Assurance, SDLC, SOP, ISO 13485, Biotechnology, GAMP
Education
Davenport University 2008 — 2010
Bachelor of Applied Science, Biometric Security
SQA
Performance Validation September 2011 - Present
Performance Validation September 2011 - July 2012
MPI Research November 2006 - September 2011
Skills
Computer System..., GMP, FDA GMP, GLP, Validation, Instrument Validation, Pharmaceutical Industry, Medical Devices, HPLC, Management, Project Management, GxP, 21 CFR Part 11, FDA, Software Documentation, LIMS, CRO, Testing, Sop, Change Control, V&V, Laboratory, Quality System, Quality Control, CAPA, Regulatory Affairs, Quality Assurance, SDLC, SOP, ISO 13485, Biotechnology, GAMP
Education
Davenport University 2008 — 2010
Bachelor of Applied Science, Biometric Security
SQA
Brian Larmon Brian Larmon's Performance Validation Experience September 2014 - Present
Job Sr. Validation Engineer, Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation September 2014 - Present
Nephron Pharmaceuticals January 2013 - August 2014
The Ritedose Corporation, (TRC) August 2007 - January 2013
Pratt Industries August 2006 - August 2007
Skills
Validation, GMP, Manufacturing, Microsoft Office, PowerPoint, Pharmaceutical Industry, Budgets, Small Business, Quality Assurance, Microsoft Word, Microsoft Excel, Negotiation, V&V, FDA, Quality Control, SOP, CAPA
Education
Clemson University 2002 — 2006
Packaging Science
Performance Validation September 2014 - Present
Nephron Pharmaceuticals January 2013 - August 2014
The Ritedose Corporation, (TRC) August 2007 - January 2013
Pratt Industries August 2006 - August 2007
Skills
Validation, GMP, Manufacturing, Microsoft Office, PowerPoint, Pharmaceutical Industry, Budgets, Small Business, Quality Assurance, Microsoft Word, Microsoft Excel, Negotiation, V&V, FDA, Quality Control, SOP, CAPA
Education
Clemson University 2002 — 2006
Packaging Science
Robert Chew Robert Chew's Performance Validation Experience 1990 - 1996
Job President at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc 2008 - Present
Commissioning Agents, Inc 1996 - 2008
Performance Validation 1990 - 1996
Sonalysts 1988 - 1990
Teton Adventures 1986 - 1988
United States Navy 1981 - 1986
Education
Case Western Reserve University 1978 — 1981
BS, Chemical Engineering
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
Karah Hickman's Performance Validation Experience July 2012 - August 2014
Job Development Engineer at Cook Medical
Industry Medical Devices
Experience
Cook Medical August 2014 - Present
Performance Validation July 2012 - August 2014
Bloomington High School South August 2012 - October 2013
Rose-Hulman Institute of Technology September 2008 - July 2012
Rose-Hulman Institute of Technology May 2010 - August 2011
Crossroads of America Volleyball Club December 2009 - April 2011
Skills
Matlab, Biomechanics, Microsoft Office, Biomaterials, Labview, Statistics, Science, Research, Technical Writing, cGMP practices, Aseptic Processing, ISO, ICH guidelines, Pharmaceutical Packaging, Instrument Validation, Process Simulation, Active Pharmaceutical..., Parenteral, Drug Product, Complaint Investigations, Quality System..., FDA GMP, Process Validation, Statgraphics
Education
Rose-Hulman Institute of Technology 2008 — 2012
B.S, Biomedical Engineering
Cook Medical August 2014 - Present
Performance Validation July 2012 - August 2014
Bloomington High School South August 2012 - October 2013
Rose-Hulman Institute of Technology September 2008 - July 2012
Rose-Hulman Institute of Technology May 2010 - August 2011
Crossroads of America Volleyball Club December 2009 - April 2011
Skills
Matlab, Biomechanics, Microsoft Office, Biomaterials, Labview, Statistics, Science, Research, Technical Writing, cGMP practices, Aseptic Processing, ISO, ICH guidelines, Pharmaceutical Packaging, Instrument Validation, Process Simulation, Active Pharmaceutical..., Parenteral, Drug Product, Complaint Investigations, Quality System..., FDA GMP, Process Validation, Statgraphics
Education
Rose-Hulman Institute of Technology 2008 — 2012
B.S, Biomedical Engineering
Andrew McLeish's Performance Validation Experience June 2010 - October 2010
Job Equipment Engineer II at Boston Scientific
Industry Medical Devices
Experience
Boston Scientific September 2012 - Present
Beckman Coulter October 2010 - September 2012
Performance Validation June 2010 - October 2010
Rose-Hulman Institute of Technology BME WILL Center of October 2009 - May 2010
Rose-Hulman Ventures September 2009 - May 2010
Medivative Technologies June 2009 - August 2009
Hologic, Inc June 2008 - August 2008
Skills
Biomedical Engineering, Creative Problem Solving, FDA, GMP, Calibration, Process Engineering, Protocol, Process Manufacturing, Medical Devices, Validation, Testing, V&V, Machining, Minitab, Labview, Matlab, Engineering, Design of Experiments, Software Documentation, ISO 13485, Product Development, Automation, CAPA, Design Control
Education
Rose-Hulman Institute of Technology 2006 — 2010
Bachelor, Biomedical Engineering
T.C Howe Academy
Boston Scientific September 2012 - Present
Beckman Coulter October 2010 - September 2012
Performance Validation June 2010 - October 2010
Rose-Hulman Institute of Technology BME WILL Center of October 2009 - May 2010
Rose-Hulman Ventures September 2009 - May 2010
Medivative Technologies June 2009 - August 2009
Hologic, Inc June 2008 - August 2008
Skills
Biomedical Engineering, Creative Problem Solving, FDA, GMP, Calibration, Process Engineering, Protocol, Process Manufacturing, Medical Devices, Validation, Testing, V&V, Machining, Minitab, Labview, Matlab, Engineering, Design of Experiments, Software Documentation, ISO 13485, Product Development, Automation, CAPA, Design Control
Education
Rose-Hulman Institute of Technology 2006 — 2010
Bachelor, Biomedical Engineering
T.C Howe Academy
Daren Wade's Performance Validation Experience November 2011 - Present
Job Validation Engineer at Performance Validation
Industry Facilities Services
Experience
Performance Validation November 2011 - Present
BSA LifeStructures January 2007 - October 2011
Education
Indiana State University 2004 — 2006
BS, Mathematics Education
Rose-Hulman Institute of Technology 1999 — 2003
BS, Mechanical Engineering
Performance Validation November 2011 - Present
BSA LifeStructures January 2007 - October 2011
Education
Indiana State University 2004 — 2006
BS, Mathematics Education
Rose-Hulman Institute of Technology 1999 — 2003
BS, Mechanical Engineering
JW Jenkins JW Jenkins's Performance Validation Experience 2003 - 2008
Job President JWJ Enterprises, Inc.
Industry Pharmaceuticals
Experience
Sandoz October 2011 - Present
JWJ Enterprises, Inc. October 2008 - Present
J & J Enterprises October 2008 - Present
Pfizer July 2011 - October 2011
Artegraft March 2011 - May 2011
Griffin Engineering and Technical Services September 2009 - September 2010
Eli Lilly and Company 2004 - 2008
Performance Validation 2003 - 2008
CropTech 2002 - 2003
Schwarz Pharma January 1997 - January 2002
Skills
ASTM 2500 Verification, Medical Devices, GMP, Troubleshooting, Validation, Manufacturing, Change Management, Engineering, Process Engineering, Procurement, Planning, SOP, Start-ups, Packaging, Quality Systems, Production, 21 CFR Part 11, Life Sciences, Supervisory Skills, cGMP, CAPA, HVAC, Word, Commissioning, Documentation, Problem Solving, Instrumentation, Project Planning, Calibration, MS Project, Team Building, Manufacturing Management, Change Control, Sop, Microsoft Word, Quality System, Computer System..., Software Documentation, Biopharmaceuticals, Automation, V&V, Quality Assurance, FDA, Lifesciences, Biotechnology, Technology Transfer, Regulatory Requirements, GLP, GAMP, Pharmaceutical Industry
Education
University of Maryland Baltimore 1995 — 1996
University of Michigan 1975 — 1979
Mechanical Engineeering
Sandoz October 2011 - Present
JWJ Enterprises, Inc. October 2008 - Present
J & J Enterprises October 2008 - Present
Pfizer July 2011 - October 2011
Artegraft March 2011 - May 2011
Griffin Engineering and Technical Services September 2009 - September 2010
Eli Lilly and Company 2004 - 2008
Performance Validation 2003 - 2008
CropTech 2002 - 2003
Schwarz Pharma January 1997 - January 2002
Skills
ASTM 2500 Verification, Medical Devices, GMP, Troubleshooting, Validation, Manufacturing, Change Management, Engineering, Process Engineering, Procurement, Planning, SOP, Start-ups, Packaging, Quality Systems, Production, 21 CFR Part 11, Life Sciences, Supervisory Skills, cGMP, CAPA, HVAC, Word, Commissioning, Documentation, Problem Solving, Instrumentation, Project Planning, Calibration, MS Project, Team Building, Manufacturing Management, Change Control, Sop, Microsoft Word, Quality System, Computer System..., Software Documentation, Biopharmaceuticals, Automation, V&V, Quality Assurance, FDA, Lifesciences, Biotechnology, Technology Transfer, Regulatory Requirements, GLP, GAMP, Pharmaceutical Industry
Education
University of Maryland Baltimore 1995 — 1996
University of Michigan 1975 — 1979
Mechanical Engineeering
Julie Chang's Performance Validation Experience September 2008 - June 2009
Job Business Integrator @ Eli Lilly for SmartIT
Industry Pharmaceuticals
Experience
SmartIT (Staffing & Solutions) May 2013 - Present
SmartIT (Staffing & Solutions) July 2014 - August 2015
SmartIT (Staffing & Solutions) May 2013 - July 2014
BCforward March 2013 - May 2013
BCforward August 2012 - March 2013
LabCorp/ DCL Medical Labs June 2009 - August 2012
Performance Validation September 2008 - June 2009
Rockwell Automation July 2003 - September 2008
Technisource at Roche Diagnostics 2001 - 2003
Analysts International at Eli Lilly 2000 - 2001
Skills
Quality Assurance, Computer System..., Procedure Creation, 21 CFR Part 11, Technical Writing, GAMP, Process Simulation, SOP development, CAP, Software Documentation, Change Control, Validation, FDA, Process Improvement, SDLC, Visio, CAPA, Quality System, 21 CFR, MS Project, Microsoft Office, Disaster Recovery, Business Continuity..., Sop, Pharmaceutical Industry, GxP, GMP, Testing, Quality Control, Analysis, V&V, Quality Management, Document Management, Requirements Analysis, Software Quality..., Automation, Documentum, SharePoint, Cross-functional Team..., Quality Center, Change Management, Quality Auditing, Leadership, Management, User Acceptance Testing, Six Sigma, Business Process, Agile Methodologies, Requirements Gathering, Project Planning
Education
Ball State University 1999 — 2001
MS, Information and Communication Science
Purdue University 1994 — 1996
BA, English Literature
SmartIT (Staffing & Solutions) May 2013 - Present
SmartIT (Staffing & Solutions) July 2014 - August 2015
SmartIT (Staffing & Solutions) May 2013 - July 2014
BCforward March 2013 - May 2013
BCforward August 2012 - March 2013
LabCorp/ DCL Medical Labs June 2009 - August 2012
Performance Validation September 2008 - June 2009
Rockwell Automation July 2003 - September 2008
Technisource at Roche Diagnostics 2001 - 2003
Analysts International at Eli Lilly 2000 - 2001
Skills
Quality Assurance, Computer System..., Procedure Creation, 21 CFR Part 11, Technical Writing, GAMP, Process Simulation, SOP development, CAP, Software Documentation, Change Control, Validation, FDA, Process Improvement, SDLC, Visio, CAPA, Quality System, 21 CFR, MS Project, Microsoft Office, Disaster Recovery, Business Continuity..., Sop, Pharmaceutical Industry, GxP, GMP, Testing, Quality Control, Analysis, V&V, Quality Management, Document Management, Requirements Analysis, Software Quality..., Automation, Documentum, SharePoint, Cross-functional Team..., Quality Center, Change Management, Quality Auditing, Leadership, Management, User Acceptance Testing, Six Sigma, Business Process, Agile Methodologies, Requirements Gathering, Project Planning
Education
Ball State University 1999 — 2001
MS, Information and Communication Science
Purdue University 1994 — 1996
BA, English Literature
Brad Henry's Performance Validation Experience June 1999 - Present
Job Vice President at Performance Validation and Pharmaceuticals Consultant
Industry Pharmaceuticals
Experience
Performance Validation June 1999 - Present
Roche Diagnostics 2005 - 2009
Skills
GMP, Quality Auditing, Validation, Commissioning, Medical Devices, 21 CFR Part 11, Change Control, FDA, Computer System..., Six Sigma, Testing, V&V, Continuous Improvement, Automation, Pharmaceutical Industry, Quality System, CAPA, ISO 13485, Sop, Quality Assurance, Regulatory Affairs, Biotechnology, Biopharmaceuticals, Quality Control, Technology Transfer, Root Cause Analysis, Process Simulation, Project Management
Education
Indiana University - Kelley School of Business 2011 — 2012
ECBLS, Business
Rose-Hulman Institute of Technology 1995 — 1999
Bachelor of Science (BS), Mechanical Engineering
New London High School 1992 — 1995
Performance Validation June 1999 - Present
Roche Diagnostics 2005 - 2009
Skills
GMP, Quality Auditing, Validation, Commissioning, Medical Devices, 21 CFR Part 11, Change Control, FDA, Computer System..., Six Sigma, Testing, V&V, Continuous Improvement, Automation, Pharmaceutical Industry, Quality System, CAPA, ISO 13485, Sop, Quality Assurance, Regulatory Affairs, Biotechnology, Biopharmaceuticals, Quality Control, Technology Transfer, Root Cause Analysis, Process Simulation, Project Management
Education
Indiana University - Kelley School of Business 2011 — 2012
ECBLS, Business
Rose-Hulman Institute of Technology 1995 — 1999
Bachelor of Science (BS), Mechanical Engineering
New London High School 1992 — 1995
Daniel Franklin, CIRM, CxA's Performance Validation Experience 1992 - 1999
Job Regional Compliance Manager at Integrated Project Services (IPS)
Industry Pharmaceuticals
Experience
IPS-Integrated Project Services, Inc. April 2008 - Present
Eli Lilly and Company February 1999 - March 2008
Performance Validation 1992 - 1999
Aerojet Rocketdyne (Rockwell) January 1985 - April 1992
Brevard Community College January 1990 - June 1991
US Army June 1976 - June 1980
Skills
Validation, FDA, Project Management, GMP, V&V, Commissioning, Computer System..., Change Control, Manufacturing, Software Documentation, Pharmaceutical Industry, 21 CFR Part 11, Project Planning, Sop, Biotechnology, Quality Assurance, CAPA, Quality System, GAMP, Biopharmaceuticals, Facilities Management, Root Cause Analysis, Engineering, Regulatory Requirements, Aseptic Processing, Medical Devices, Process Improvement, LIMS, Quality Management, Regulatory Submissions, GxP, Regulatory Affairs, GLP, GCP, Quality Control, Risk Assessment, Leadership, Technical Writing, Continuous Improvement, Trackwise, Risk-based Verification, Quality Auditing, Process Simulation
Education
National University 1986 — 1989
MBA, Business Adnim
Lewis University 1982 — 1984
BS, Aviation Maintenance Management
Moraine Valley Community College 1980 — 1982
AS, Liberal Arts
IPS-Integrated Project Services, Inc. April 2008 - Present
Eli Lilly and Company February 1999 - March 2008
Performance Validation 1992 - 1999
Aerojet Rocketdyne (Rockwell) January 1985 - April 1992
Brevard Community College January 1990 - June 1991
US Army June 1976 - June 1980
Skills
Validation, FDA, Project Management, GMP, V&V, Commissioning, Computer System..., Change Control, Manufacturing, Software Documentation, Pharmaceutical Industry, 21 CFR Part 11, Project Planning, Sop, Biotechnology, Quality Assurance, CAPA, Quality System, GAMP, Biopharmaceuticals, Facilities Management, Root Cause Analysis, Engineering, Regulatory Requirements, Aseptic Processing, Medical Devices, Process Improvement, LIMS, Quality Management, Regulatory Submissions, GxP, Regulatory Affairs, GLP, GCP, Quality Control, Risk Assessment, Leadership, Technical Writing, Continuous Improvement, Trackwise, Risk-based Verification, Quality Auditing, Process Simulation
Education
National University 1986 — 1989
MBA, Business Adnim
Lewis University 1982 — 1984
BS, Aviation Maintenance Management
Moraine Valley Community College 1980 — 1982
AS, Liberal Arts
Marc Anderson's Performance Validation Experience December 2001 - January 2005
Job Principal Validation Engineer at ZymoGenetics (a BristolMyers Squibb Company)
Industry Biotechnology
Experience
ZymoGenetics (a Bristol-Myers Squibb Company) May 2015 - Present
Seattle Genetics September 2013 - May 2015
Dendreon December 2009 - September 2013
Amgen February 2005 - July 2009
Performance Validation December 2001 - January 2005
Perrigo May 1999 - August 2000
Skills
21 CFR Part 11, FDA, Change Control, Validation, CAPA, GMP, Computer System..., Quality System, LIMS, Quality Assurance, GxP
Education
Michigan State University 1997 — 2001
BS, Chemical Engineering
Oregon State University 2013 — 2013
Coursework in Computer Science
ZymoGenetics (a Bristol-Myers Squibb Company) May 2015 - Present
Seattle Genetics September 2013 - May 2015
Dendreon December 2009 - September 2013
Amgen February 2005 - July 2009
Performance Validation December 2001 - January 2005
Perrigo May 1999 - August 2000
Skills
21 CFR Part 11, FDA, Change Control, Validation, CAPA, GMP, Computer System..., Quality System, LIMS, Quality Assurance, GxP
Education
Michigan State University 1997 — 2001
BS, Chemical Engineering
Oregon State University 2013 — 2013
Coursework in Computer Science
Brian Huff, CMQ/OE, CQA's Performance Validation Experience October 2000 - April 2006
Job Quality System Manager at Indigo BioAutomation, Inc.
Industry Information Technology and Services
Experience
Indigo BioAutomation May 2014 - Present
MiraVista Diagnostics August 2013 - May 2014
MiraVista Diagnostics March 2011 - August 2013
Vesta Pharmaceuticals, Inc. September 2010 - March 2011
Self Employed April 2009 - September 2010
Outbound Technologies April 2006 - April 2009
Performance Validation October 2000 - April 2006
Skills
Quality Assurance, FDA, Quality System, ISO 13485, Medical Devices, Validation, Computer System..., Change Control, GMP, V&V, CAPA, Quality Auditing, Testing, Risk Management, 21 CFR Part 11, Automation, ISO, Quality Control, Manufacturing, Cleaning Validation, Project Management, GAMP, GxP, Pharmaceutical Industry, Sop, Equipment Qualification
Education
Rose-Hulman Institute of Technology 1995 — 2000
Bachelor of Science, Chemical Engineering
Indigo BioAutomation May 2014 - Present
MiraVista Diagnostics August 2013 - May 2014
MiraVista Diagnostics March 2011 - August 2013
Vesta Pharmaceuticals, Inc. September 2010 - March 2011
Self Employed April 2009 - September 2010
Outbound Technologies April 2006 - April 2009
Performance Validation October 2000 - April 2006
Skills
Quality Assurance, FDA, Quality System, ISO 13485, Medical Devices, Validation, Computer System..., Change Control, GMP, V&V, CAPA, Quality Auditing, Testing, Risk Management, 21 CFR Part 11, Automation, ISO, Quality Control, Manufacturing, Cleaning Validation, Project Management, GAMP, GxP, Pharmaceutical Industry, Sop, Equipment Qualification
Education
Rose-Hulman Institute of Technology 1995 — 2000
Bachelor of Science, Chemical Engineering
David Kugler, MBA's Performance Validation Experience 2003 - 2006
Job Global Quality Compliance Systems Director at GOJO Industries
Industry Consumer Goods
Experience
GOJO Industries February 2015 - Present
GOJO Industries April 2012 - January 2015
GOJO Industries July 2011 - March 2012
GOJO Industries March 2010 - June 2011
Rx GLOBAL Consulting Solutions Inc. September 2009 - February 2010
Kelley School of Business January 2009 - December 2009
Adecco Technical January 2007 - December 2008
ProPharma Group September 2006 - December 2006
Performance Validation 2003 - 2006
Skills
Validation, Process Improvement, Engineering, Quality Assurance, Root Cause Analysis, Change Control, Cross-functional Team..., Quality System, CAPA, Six Sigma, Manufacturing, Continuous Improvement, V&V, Quality Control, Lean Manufacturing, Deviation Management, Quality Auditing, Supply Chain, Computer System...
Education
Indiana University - Kelley School of Business 2007 — 2010
MBA, Supply Chain Management
Rose-Hulman Institute of Technology 1998 — 2003
BS, Mechanical Engineering
University of Stuttgart 2000 — 2001
Mechanical Engineering
GOJO Industries February 2015 - Present
GOJO Industries April 2012 - January 2015
GOJO Industries July 2011 - March 2012
GOJO Industries March 2010 - June 2011
Rx GLOBAL Consulting Solutions Inc. September 2009 - February 2010
Kelley School of Business January 2009 - December 2009
Adecco Technical January 2007 - December 2008
ProPharma Group September 2006 - December 2006
Performance Validation 2003 - 2006
Skills
Validation, Process Improvement, Engineering, Quality Assurance, Root Cause Analysis, Change Control, Cross-functional Team..., Quality System, CAPA, Six Sigma, Manufacturing, Continuous Improvement, V&V, Quality Control, Lean Manufacturing, Deviation Management, Quality Auditing, Supply Chain, Computer System...
Education
Indiana University - Kelley School of Business 2007 — 2010
MBA, Supply Chain Management
Rose-Hulman Institute of Technology 1998 — 2003
BS, Mechanical Engineering
University of Stuttgart 2000 — 2001
Mechanical Engineering
LaTisha Egenolf, PMP's Performance Validation Experience December 2002 - January 2007
Job Project Management Engineer
Industry Aviation & Aerospace
Experience
Rolls-Royce April 2009 - Present
Arroyo Industries, LLC 2004 - Present
Wachovia Securities Financial Network February 2007 - March 2009
Performance Validation December 2002 - January 2007
Parsons November 2001 - November 2002
Skills
Certified Project..., Cross-functional Team..., Risk Management, Engineering, Manufacturing, Budgets, Procurement, Aerospace, Project Planning, MS Project, Construction, Project Management, SAP, Engineering Management, Process Simulation, Validation, Product Development
Education
Rose-Hulman Institute of Technology 1997 — 2001
B.S., Chemical Engineer
Rolls-Royce April 2009 - Present
Arroyo Industries, LLC 2004 - Present
Wachovia Securities Financial Network February 2007 - March 2009
Performance Validation December 2002 - January 2007
Parsons November 2001 - November 2002
Skills
Certified Project..., Cross-functional Team..., Risk Management, Engineering, Manufacturing, Budgets, Procurement, Aerospace, Project Planning, MS Project, Construction, Project Management, SAP, Engineering Management, Process Simulation, Validation, Product Development
Education
Rose-Hulman Institute of Technology 1997 — 2001
B.S., Chemical Engineer
Peter Argiris's Performance Validation Experience 2004 - 2008
Job Sr. Project Manager at Heartland Food Products Group, LLC
Industry Food & Beverages
Experience
Heartland Sweeteners, LLC February 2012 - Present
Colorcon August 2008 - January 2012
Performance Validation 2004 - 2008
Quaker Oats 2004 - 2004
Frito Lay 2002 - 2003
Frito Lay 2001 - 2002
Skills
GMP, V&V, CAPA, Six Sigma, Validation, Continuous Improvement, FDA, 5S, Change Control, Manufacturing, Lean Manufacturing, Root Cause Analysis, Process Engineering, Quality System, Sop, Pharmaceutical Industry, Process Improvement, Quality Assurance, Project Management, DMAIC, Cross-functional Team..., Project Engineering, Design of Experiments, Maintenance Management, Food Processing, Process Optimization
Education
Rose-Hulman Institute of Technology 1997 — 2001
Bachelor of Science (BS), Chemical Engineering
Heartland Sweeteners, LLC February 2012 - Present
Colorcon August 2008 - January 2012
Performance Validation 2004 - 2008
Quaker Oats 2004 - 2004
Frito Lay 2002 - 2003
Frito Lay 2001 - 2002
Skills
GMP, V&V, CAPA, Six Sigma, Validation, Continuous Improvement, FDA, 5S, Change Control, Manufacturing, Lean Manufacturing, Root Cause Analysis, Process Engineering, Quality System, Sop, Pharmaceutical Industry, Process Improvement, Quality Assurance, Project Management, DMAIC, Cross-functional Team..., Project Engineering, Design of Experiments, Maintenance Management, Food Processing, Process Optimization
Education
Rose-Hulman Institute of Technology 1997 — 2001
Bachelor of Science (BS), Chemical Engineering
Marsha Holt's Performance Validation Experience 2003 - 2005
Job Quality Assurance / Validation Consultant
Industry Pharmaceuticals
Experience
Evonik Laboratories January 2015 - Present
Compli LLC October 2009 - Present
Nesher Pharmaceuticals (USA) LLC October 2009 - May 2013
Evonik 2013 - 2013
Bayer HealthCare 2007 - 2009
Crabtree & Associates, LLC March 2005 - June 2007
Performance Validation 2003 - 2005
Bayer HealthCare 1995 - 2000
Sanofi Winthrop 1991 - 1994
Marion Merrell-Dow 1981 - 1991
Skills
FDA, Validation, Laboratory Equipment, Aseptic Technique, Information Systems, GLP, GMP, Quality Assurance, Aseptic Processing, GxP, Quality System, Pharmaceutical Industry, Quality Control, 21 CFR Part 11, Medical Devices, Change Control, GAMP, Sop, Pharmaceutics, Technology Transfer, Regulatory Requirements, SOP development, Trackwise, Document Management, Equipment Qualification, CAPA, V&V, Software Documentation, Microbiology, Quality Auditing, Cleaning Validation, LIMS, Regulatory Affairs, Biopharmaceuticals, Regulatory Submissions, Biotechnology, Laboratory, HPLC, Chromatography, Analytical Chemistry, Lifesciences, ISO 13485, Vaccines, GCP, Clinical Trials, Process Simulation, Drug Development, R&D, Computer System..., SOP
Education
Avila University 1989 — 1990
Natural Science
Longview Community College 1986 — 1988
Associate of Arts, Emphasis in Science
Evonik Laboratories January 2015 - Present
Compli LLC October 2009 - Present
Nesher Pharmaceuticals (USA) LLC October 2009 - May 2013
Evonik 2013 - 2013
Bayer HealthCare 2007 - 2009
Crabtree & Associates, LLC March 2005 - June 2007
Performance Validation 2003 - 2005
Bayer HealthCare 1995 - 2000
Sanofi Winthrop 1991 - 1994
Marion Merrell-Dow 1981 - 1991
Skills
FDA, Validation, Laboratory Equipment, Aseptic Technique, Information Systems, GLP, GMP, Quality Assurance, Aseptic Processing, GxP, Quality System, Pharmaceutical Industry, Quality Control, 21 CFR Part 11, Medical Devices, Change Control, GAMP, Sop, Pharmaceutics, Technology Transfer, Regulatory Requirements, SOP development, Trackwise, Document Management, Equipment Qualification, CAPA, V&V, Software Documentation, Microbiology, Quality Auditing, Cleaning Validation, LIMS, Regulatory Affairs, Biopharmaceuticals, Regulatory Submissions, Biotechnology, Laboratory, HPLC, Chromatography, Analytical Chemistry, Lifesciences, ISO 13485, Vaccines, GCP, Clinical Trials, Process Simulation, Drug Development, R&D, Computer System..., SOP
Education
Avila University 1989 — 1990
Natural Science
Longview Community College 1986 — 1988
Associate of Arts, Emphasis in Science
Brian Zylla, P.E.'s Performance Validation Experience August 2000 - Present
Job Principal Validation Engineer at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation August 2000 - Present
Western Michigan University August 1999 - May 2000
Cytec April 1995 - February 1999
Skills
Budgets, Computer System..., Validation, V&V, 21 CFR Part 11, GMP, Change Control, FDA, Pharmaceutical Industry, Quality System, Quality Assurance, Commissioning, Aseptic Processing, GAMP, Automation, Quality Control, Standards Development, Project Management
Education
University of Michigan 1993 — 1995
MS, Chemical Engineering
Purdue University 1988 — 1993
BS, Chemical Engineering
Performance Validation August 2000 - Present
Western Michigan University August 1999 - May 2000
Cytec April 1995 - February 1999
Skills
Budgets, Computer System..., Validation, V&V, 21 CFR Part 11, GMP, Change Control, FDA, Pharmaceutical Industry, Quality System, Quality Assurance, Commissioning, Aseptic Processing, GAMP, Automation, Quality Control, Standards Development, Project Management
Education
University of Michigan 1993 — 1995
MS, Chemical Engineering
Purdue University 1988 — 1993
BS, Chemical Engineering
Todd Karmes's Performance Validation Experience January 2001 - August 2005
Job Plant Quality Manager at Medtronic
Industry Medical Devices
Experience
Medtronic June 2014 - Present
Covidien July 2014 - January 2015
Covidien September 2005 - July 2014
Performance Validation January 2001 - August 2005
Skills
CAPA, FDA, Validation, Medical Devices, GMP, DMAIC, SPC, Quality Systems, Process Validation, SOP, 21 CFR Part 11, Quality Assurance, cGMP, Automation, Six Sigma, Continuous Improvement, Lean Manufacturing, Technical Writing, Minitab, Troubleshooting, Computer System..., Compliance, Cleaning Validation, Commissioning, Quality Management, Statistics, PLC, Risk Analysis, Excel, Word, PowerPoint, Production, Coaching, ISO 13485, HVAC, Documentation, Process Improvement, Auditing, Problem Solving, FMEA, Quality System, V&V, ISO, Manufacturing, Software Documentation, Design of Experiments, Sop, R&D
Education
Michigan State University 1996 — 2001
Bachelor of Science (B.S.), Mechanical Engineering
Medtronic June 2014 - Present
Covidien July 2014 - January 2015
Covidien September 2005 - July 2014
Performance Validation January 2001 - August 2005
Skills
CAPA, FDA, Validation, Medical Devices, GMP, DMAIC, SPC, Quality Systems, Process Validation, SOP, 21 CFR Part 11, Quality Assurance, cGMP, Automation, Six Sigma, Continuous Improvement, Lean Manufacturing, Technical Writing, Minitab, Troubleshooting, Computer System..., Compliance, Cleaning Validation, Commissioning, Quality Management, Statistics, PLC, Risk Analysis, Excel, Word, PowerPoint, Production, Coaching, ISO 13485, HVAC, Documentation, Process Improvement, Auditing, Problem Solving, FMEA, Quality System, V&V, ISO, Manufacturing, Software Documentation, Design of Experiments, Sop, R&D
Education
Michigan State University 1996 — 2001
Bachelor of Science (B.S.), Mechanical Engineering
Holly Couch's Performance Validation Experience January 2000 - Present
Job Sr. Engineer at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation January 2000 - Present
Skills
Process Equipment, Validation, GMP, Computer System..., Medical Devices, Manufacturing, GAMP, Cleaning Validation, V&V, Instrumentation, FDA, CAPA, 21 CFR Part 11, Change Control, Aseptic Processing, Quality System, Root Cause Analysis, Minitab, Automation, Sop
Education
Indiana University - Kelley School of Business 2003 — 2006
MBA, Venture & Technology Management
Purdue University 1995 — 1999
BS, Mechanical Engineering
Performance Validation January 2000 - Present
Skills
Process Equipment, Validation, GMP, Computer System..., Medical Devices, Manufacturing, GAMP, Cleaning Validation, V&V, Instrumentation, FDA, CAPA, 21 CFR Part 11, Change Control, Aseptic Processing, Quality System, Root Cause Analysis, Minitab, Automation, Sop
Education
Indiana University - Kelley School of Business 2003 — 2006
MBA, Venture & Technology Management
Purdue University 1995 — 1999
BS, Mechanical Engineering
James Deyerle's Performance Validation Experience August 2011 - January 2012
Job Global Process Safety Engineer at Dow AgroSciences
Industry Mechanical or Industrial Engineering
Experience
Dow AgroSciences March 2012 - Present
Performance Validation August 2011 - January 2012
Railroad Commission of Texas August 2009 - August 2011
Boeing Commercial Airplanes May 2008 - August 2008
GXStudios 2008 - 2008
Rice University May 2007 - August 2007
Skills
Process Improvement, Engineering, Matlab, Analysis, Microsoft Office, Product Development, Process Safety, Loss Prevention, Mechanical Engineering, Maximo, FMEA, Six Sigma, Preventive Maintenance, SolidWorks, Data Analysis, Process Engineering, Root Cause Analysis
Education
Rice University 2005 — 2009
BS, Mechanical Engineering
Dow AgroSciences March 2012 - Present
Performance Validation August 2011 - January 2012
Railroad Commission of Texas August 2009 - August 2011
Boeing Commercial Airplanes May 2008 - August 2008
GXStudios 2008 - 2008
Rice University May 2007 - August 2007
Skills
Process Improvement, Engineering, Matlab, Analysis, Microsoft Office, Product Development, Process Safety, Loss Prevention, Mechanical Engineering, Maximo, FMEA, Six Sigma, Preventive Maintenance, SolidWorks, Data Analysis, Process Engineering, Root Cause Analysis
Education
Rice University 2005 — 2009
BS, Mechanical Engineering
Kevin DeBruyn's Performance Validation Experience 2001 - January 2004
Job Supervisor Nutrilite Quality Assurance
Industry Consumer Goods
Experience
Amway October 2014 - Present
Amway January 2013 - September 2014
Amway May 2009 - January 2013
Amway April 2006 - May 2009
Amway January 2004 - April 2006
Performance Validation 2001 - January 2004
Elopak 2000 - 2000
Performance Validation 1998 - 2000
Skills
Regulatory Affairs, GMP, Validation, Cross-functional Team..., Process Improvement, Pharmaceutical Industry, Quality Assurance, Project Management, Team Leadership, Change Management, Quality Control, Technology Transfer, Testing, Leadership, Change Control
Education
Kalamazoo College 1994 — 1998
B.A., Biology
Amway October 2014 - Present
Amway January 2013 - September 2014
Amway May 2009 - January 2013
Amway April 2006 - May 2009
Amway January 2004 - April 2006
Performance Validation 2001 - January 2004
Elopak 2000 - 2000
Performance Validation 1998 - 2000
Skills
Regulatory Affairs, GMP, Validation, Cross-functional Team..., Process Improvement, Pharmaceutical Industry, Quality Assurance, Project Management, Team Leadership, Change Management, Quality Control, Technology Transfer, Testing, Leadership, Change Control
Education
Kalamazoo College 1994 — 1998
B.A., Biology
Neil Enlow, PMP's Performance Validation Experience February 2001 - Present
Job Division Manager and Principal Engineer
Industry Pharmaceuticals
Experience
Performance Validation February 2001 - Present
Eli Lilly February 2001 - Present
Sterling Fluid Systems January 1999 - February 2001
Skills
Project Management, Validation
Education
Purdue University 1994 — 1998
BSME, Mechanical Engineering
Performance Validation February 2001 - Present
Eli Lilly February 2001 - Present
Sterling Fluid Systems January 1999 - February 2001
Skills
Project Management, Validation
Education
Purdue University 1994 — 1998
BSME, Mechanical Engineering
Edward Standen's Performance Validation Experience February 2015 - Present
Job Validation Engineer at Performance Validation
Industry Mechanical or Industrial Engineering
Experience
Performance Validation February 2015 - Present
US Navy January 2010 - December 2014
Skills
Navy, Nuclear, Nuclear Engineering, Engineering, Reactor, Nuclear Safety, Security Clearance, Microsoft Office, Nuclear Power Plants, Mechanical Engineering, Matlab, Military, Maintenance Management, Project Management, Plant Operations, Preventive Maintenance, Steam Turbines, Military Experience, Microsoft Excel, Planned Preventative..., Command, Hydraulic Systems, Steam, SolidWorks, AutoCAD, Autodesk Inventor, Validation, Process Validation
Education
Valparaiso University 2004 — 2009
BSME, Mechanical Engineering
Navy Nuclear Power Training Command 2010 — 2012
Nuclear Engineering Technology, 3.5/4.0
St Joseph High School 2000 — 2004
Central Michigan University 2015 — 2017
Master of Science, Engineering/Industrial Management
Performance Validation February 2015 - Present
US Navy January 2010 - December 2014
Skills
Navy, Nuclear, Nuclear Engineering, Engineering, Reactor, Nuclear Safety, Security Clearance, Microsoft Office, Nuclear Power Plants, Mechanical Engineering, Matlab, Military, Maintenance Management, Project Management, Plant Operations, Preventive Maintenance, Steam Turbines, Military Experience, Microsoft Excel, Planned Preventative..., Command, Hydraulic Systems, Steam, SolidWorks, AutoCAD, Autodesk Inventor, Validation, Process Validation
Education
Valparaiso University 2004 — 2009
BSME, Mechanical Engineering
Navy Nuclear Power Training Command 2010 — 2012
Nuclear Engineering Technology, 3.5/4.0
St Joseph High School 2000 — 2004
Central Michigan University 2015 — 2017
Master of Science, Engineering/Industrial Management
Christie (Shadrach) Maleski, PE's Performance Validation Experience November 2002 - May 2003
Job Plant Engineer at Tremco
Industry Building Materials
Experience
Tremco June 2005 - Present
Tremco March 2003 - May 2005
Performance Validation November 2002 - May 2003
Cleveland Clinic 2001 - 2001
Skills
DeltaV, Engineering, Chemical Engineering, Process Improvement, ISO 14001, Iso 9000, Hazard Analysis, Process Automation, AutoCAD, SAP R/3, Emulsions, Coatings, SAP, Product Development, Testing
Education
Baldwin Wallace University 2006 — 2009
Masters, Business
Rose-Hulman Institute of Technology 1999 — 2002
BS, Chemical Engineering
Tremco June 2005 - Present
Tremco March 2003 - May 2005
Performance Validation November 2002 - May 2003
Cleveland Clinic 2001 - 2001
Skills
DeltaV, Engineering, Chemical Engineering, Process Improvement, ISO 14001, Iso 9000, Hazard Analysis, Process Automation, AutoCAD, SAP R/3, Emulsions, Coatings, SAP, Product Development, Testing
Education
Baldwin Wallace University 2006 — 2009
Masters, Business
Rose-Hulman Institute of Technology 1999 — 2002
BS, Chemical Engineering
Jeff Kamar's Performance Validation Experience 2001 - 2007
Job Process Controls Engineer at PREMIER System Integrators
Industry Industrial Automation
Experience
PREMIER System Integrators April 2013 - Present
HTSE, Inc. March 2007 - April 2013
Performance Validation 2001 - 2007
Skills
Validation, SPC, Automation, Process Control, Instrumentation, PLC, Commissioning, Engineering, GMP, Change Control, Troubleshooting, FDA, 21 CFR Part 11, CAPA, Quality System, Design of Experiments, Testing, Chemical Engineering, Process Engineering, Manufacturing
Education
University of Michigan 1996 — 2000
BSE, Chemical Engineering
PREMIER System Integrators April 2013 - Present
HTSE, Inc. March 2007 - April 2013
Performance Validation 2001 - 2007
Skills
Validation, SPC, Automation, Process Control, Instrumentation, PLC, Commissioning, Engineering, GMP, Change Control, Troubleshooting, FDA, 21 CFR Part 11, CAPA, Quality System, Design of Experiments, Testing, Chemical Engineering, Process Engineering, Manufacturing
Education
University of Michigan 1996 — 2000
BSE, Chemical Engineering
Jim Gallaher's Performance Validation Experience January 2015 - Present
Job Staff Validation Engineer at Performance Validation
Industry Biotechnology
Experience
Performance Validation January 2015 - Present
Nationwide Childrens Hospital May 2013 - Present
Clear Image Technology July 2012 - January 2013
The Ohio State University2 June 2010 - June 2012
Skills
Microsoft Office, Biotechnology, Cell Culture, PowerPoint, Microsoft Excel, Research, Matlab, Microsoft Word, Biochemistry, Lifesciences, Microbiology, ELISA, Teamwork
Education
The Ohio State University 2007 — 2011
Bachelor of Applied Science (B.A.Sc.), Biological/Biosystems Engineering
Performance Validation January 2015 - Present
Nationwide Childrens Hospital May 2013 - Present
Clear Image Technology July 2012 - January 2013
The Ohio State University2 June 2010 - June 2012
Skills
Microsoft Office, Biotechnology, Cell Culture, PowerPoint, Microsoft Excel, Research, Matlab, Microsoft Word, Biochemistry, Lifesciences, Microbiology, ELISA, Teamwork
Education
The Ohio State University 2007 — 2011
Bachelor of Applied Science (B.A.Sc.), Biological/Biosystems Engineering
Derek Fraits's Performance Validation Experience June 2008 - Present
Job Senior Validation Engineer and Project Leader at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation June 2008 - Present
EndoGastric Solutions May 2007 - August 2007
Skills
Validation, GMP, FDA, Change Control, V&V, 21 CFR Part 11, Pharmaceutical Industry, Quality Assurance, Quality System, Project Management, Manufacturing
Education
Purdue University 2004 — 2008
B.S., Mechanical Engineering
Performance Validation June 2008 - Present
EndoGastric Solutions May 2007 - August 2007
Skills
Validation, GMP, FDA, Change Control, V&V, 21 CFR Part 11, Pharmaceutical Industry, Quality Assurance, Quality System, Project Management, Manufacturing
Education
Purdue University 2004 — 2008
B.S., Mechanical Engineering
Marcy Gallagher, P.E.'s Performance Validation Experience April 2008 - October 2013
Job Associate Consultant Engineer HSE at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company October 2013 - Present
Performance Validation April 2008 - October 2013
Outbound Technologies October 2007 - April 2008
National Starch Food Innovation April 2007 - October 2007
Eli Lilly April 2005 - April 2007
Education
Rose-Hulman Institute of Technology 2001 — 2005
B.S., Chemical Engineering
Eli Lilly and Company October 2013 - Present
Performance Validation April 2008 - October 2013
Outbound Technologies October 2007 - April 2008
National Starch Food Innovation April 2007 - October 2007
Eli Lilly April 2005 - April 2007
Education
Rose-Hulman Institute of Technology 2001 — 2005
B.S., Chemical Engineering
Ericka Study's Performance Validation Experience June 2002 - June 2006
Job Sr. Engineer Quality Assurance at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company July 2013 - Present
Clarke Engineering Services January 2011 - July 2013
Performance Validation June 2002 - June 2006
Skills
Validation, Computer System..., Change Control
Education
Rose-Hulman Institute of Technology 1998 — 2002
Bachelor of Science, Chemical Engineering
Eli Lilly and Company July 2013 - Present
Clarke Engineering Services January 2011 - July 2013
Performance Validation June 2002 - June 2006
Skills
Validation, Computer System..., Change Control
Education
Rose-Hulman Institute of Technology 1998 — 2002
Bachelor of Science, Chemical Engineering
Matt Moravek's Performance Validation Experience May 2007 - Present
Job Staff Validation Engineer at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation May 2007 - Present
A.M. Todd May 2004 - August 2007
Education
Western Michigan University 2004 — 2007
BS, Chemical Engineering
Kalamazoo Valley Community College 2002 — 2004
Performance Validation May 2007 - Present
A.M. Todd May 2004 - August 2007
Education
Western Michigan University 2004 — 2007
BS, Chemical Engineering
Kalamazoo Valley Community College 2002 — 2004
Sophia Percival's Performance Validation Experience June 2009 - May 2010
Job Technical Services Team Coordinator, Small Scale Form/Fill/Finish at Cook Pharmica
Industry Pharmaceuticals
Experience
Cook Pharmica February 2014 - Present
Cook Pharmica May 2010 - February 2014
Performance Validation June 2009 - May 2010
Cook Pharmica LLC June 2008 - August 2008
Cook Biotech June 2007 - August 2007
Cook Incorporated June 2006 - August 2006
Cook Incorporated June 2005 - August 2005
Skills
Pharmaceuticals, Biotechnology, Validation, Quality Assurance, Technical Writing, Process Engineering, Pharmaceutical Industry, FDA, Quality Control, CAPA, Change Control, GMP, V&V, Quality System, Manufacturing, 21 CFR Part 11, Aseptic Processing
Education
Rose-Hulman Institute of Technology 2005 — 2009
B.S., Biomedical Engineering
Cook Pharmica February 2014 - Present
Cook Pharmica May 2010 - February 2014
Performance Validation June 2009 - May 2010
Cook Pharmica LLC June 2008 - August 2008
Cook Biotech June 2007 - August 2007
Cook Incorporated June 2006 - August 2006
Cook Incorporated June 2005 - August 2005
Skills
Pharmaceuticals, Biotechnology, Validation, Quality Assurance, Technical Writing, Process Engineering, Pharmaceutical Industry, FDA, Quality Control, CAPA, Change Control, GMP, V&V, Quality System, Manufacturing, 21 CFR Part 11, Aseptic Processing
Education
Rose-Hulman Institute of Technology 2005 — 2009
B.S., Biomedical Engineering
Vicki J Lemons's Performance Validation Experience August 2000 - June 2003
Job Validation Engineer at CSASoliance
Industry Medical Devices
Experience
CSA-Soliance April 2013 - Present
Abbott Laboratories March 2008 - January 2012
Taratec Development Corporation October 2003 - November 2007
Performance Validation August 2000 - June 2003
Helena Laboratories August 1988 - January 1992
Education
Lamar University
B.S., Biology/Biological Sciences, General
The University of Texas at Austin
B.S., Chemical Engineering
CSA-Soliance April 2013 - Present
Abbott Laboratories March 2008 - January 2012
Taratec Development Corporation October 2003 - November 2007
Performance Validation August 2000 - June 2003
Helena Laboratories August 1988 - January 1992
Education
Lamar University
B.S., Biology/Biological Sciences, General
The University of Texas at Austin
B.S., Chemical Engineering
Art Scaccia's Performance Validation Experience 2001 - 2007
Job Engineering Manager at Blommer Chocolate Co.
Industry Food & Beverages
Experience
Blommer Chocolate Co. July 2013 - Present
Ferro Corporation June 2010 - May 2013
Ferro Corporation March 2009 - May 2013
Ferro Corporation June 2007 - June 2010
Performance Validation 2001 - 2007
Skills
GMP, V&V, Validation, Process Engineering, Root Cause Analysis, Quality System, FDA, Change Control, CAPA, Manufacturing, Continuous Improvement, Chemistry, 21 CFR Part 11, Pharmaceutical Industry, Medical Devices, Computer System..., Lean Manufacturing, Quality Assurance, Quality Control
Education
Purdue University 1996 — 2001
Bachelor of Science, Chemical Engineering
Purdue University 1996 — 2001
Bachelor of Science, Chemistry
Blommer Chocolate Co. July 2013 - Present
Ferro Corporation June 2010 - May 2013
Ferro Corporation March 2009 - May 2013
Ferro Corporation June 2007 - June 2010
Performance Validation 2001 - 2007
Skills
GMP, V&V, Validation, Process Engineering, Root Cause Analysis, Quality System, FDA, Change Control, CAPA, Manufacturing, Continuous Improvement, Chemistry, 21 CFR Part 11, Pharmaceutical Industry, Medical Devices, Computer System..., Lean Manufacturing, Quality Assurance, Quality Control
Education
Purdue University 1996 — 2001
Bachelor of Science, Chemical Engineering
Purdue University 1996 — 2001
Bachelor of Science, Chemistry
Kristin Beckman's Performance Validation Experience February 2011 - Present
Job Senior Validation Specialist and Project Leader at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation February 2011 - Present
Roche Diagnostics May 2006 - December 2010
Process Fluids, Inc August 2003 - May 2006
Skills
Validation, FDA, Project Management, Equipment Qualification, 21 CFR Part 11, Quality Auditing, Analytical Chemistry
Education
Butler University 2002 — 2006
Bachelor of Science, Chemistry
Performance Validation February 2011 - Present
Roche Diagnostics May 2006 - December 2010
Process Fluids, Inc August 2003 - May 2006
Skills
Validation, FDA, Project Management, Equipment Qualification, 21 CFR Part 11, Quality Auditing, Analytical Chemistry
Education
Butler University 2002 — 2006
Bachelor of Science, Chemistry
George Onduso's Performance Validation Experience January 2013 - May 2014
Job Pharmaceutical Validation Engineer at Pharmaceutical Associates Inc
Industry Pharmaceuticals
Experience
Pharmaceutical Associates, Inc May 2014 - Present
Performance Validation January 2013 - May 2014
Upsher-Smith Laboratories April 2012 - November 2012
Cosmos Manufacturing, Nairobi, Kenya December 2003 - December 2005
Unive January 1999 - December 2003
Skills
Validation, GMP, HPLC, Regulatory Affairs, Product Development, Pharmaceutical Industry, Manufacturing, Change Control, Quality Control, SOP, FDA, Laboratory, Quality System, GLP, Pharmaceutics, CAPA, 21 CFR Part 11
Education
University of Minnesota-Twin Cities 2008 — 2011
chemical engineering, Engineering
University of Nairobi 1998 — 2003
BS, Chemistry
Pharmaceutical Associates, Inc May 2014 - Present
Performance Validation January 2013 - May 2014
Upsher-Smith Laboratories April 2012 - November 2012
Cosmos Manufacturing, Nairobi, Kenya December 2003 - December 2005
Unive January 1999 - December 2003
Skills
Validation, GMP, HPLC, Regulatory Affairs, Product Development, Pharmaceutical Industry, Manufacturing, Change Control, Quality Control, SOP, FDA, Laboratory, Quality System, GLP, Pharmaceutics, CAPA, 21 CFR Part 11
Education
University of Minnesota-Twin Cities 2008 — 2011
chemical engineering, Engineering
University of Nairobi 1998 — 2003
BS, Chemistry
Cory Ruble, P.E.'s Performance Validation Experience June 2005 - February 2013
Job Associate Consultant Engineer
Industry Pharmaceuticals
Experience
Performance Validation June 2005 - February 2013
Education
Rose-Hulman Institute of Technology 1999 — 2003
BS, Chemical Engineering
Performance Validation June 2005 - February 2013
Education
Rose-Hulman Institute of Technology 1999 — 2003
BS, Chemical Engineering
Jolie Kinney's Performance Validation Experience April 2011 - Present
Job Human Resource Manager at Performance Validation
Industry Pharmaceuticals
Experience
Performance Validation April 2011 - Present
St. Vincent Health June 2000 - April 2011
Skills
Benefits Administration, HRIS, Performance Management, Employee Relations, Onboarding, Succession Planning, Employee Benefits, Deferred Compensation, Talent Management, Employee Engagement, Applicant Tracking..., Human Resources, Talent Acquisition, Personnel Management, Management, Training, Workforce Planning, HR Policies, HR Consulting, New Hire Orientations
Education
Indiana University Bloomington
Bachelor of Arts (B.A.)
Performance Validation April 2011 - Present
St. Vincent Health June 2000 - April 2011
Skills
Benefits Administration, HRIS, Performance Management, Employee Relations, Onboarding, Succession Planning, Employee Benefits, Deferred Compensation, Talent Management, Employee Engagement, Applicant Tracking..., Human Resources, Talent Acquisition, Personnel Management, Management, Training, Workforce Planning, HR Policies, HR Consulting, New Hire Orientations
Education
Indiana University Bloomington
Bachelor of Arts (B.A.)
Timothy Druyos's Performance Validation Experience July 2013 - December 2014
Job
Industry Medical Devices
Experience
Boston Scientific January 2015 - Present
Performance Validation July 2013 - December 2014
Purdue University Residential Life August 2011 - May 2013
Bard Electrophysiology May 2012 - July 2012
AlloSource May 2011 - August 2011
Skills
Minitab, Matlab, Microsoft Office, Solidworks, Microsoft Excel, Cytotoxicity, Cell Culture, Teamwork, Catia, cGMP practices, cGMP manufacturing, Validation, Instrument Validation, Periodic Qualification..., Clean Rooms, Aseptic Technique, Medical Devices, Tensile Testing, 21 CFR Part 11, ASTM E2500, SolidWorks
Education
Purdue University 2009 — 2013
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Boston Scientific January 2015 - Present
Performance Validation July 2013 - December 2014
Purdue University Residential Life August 2011 - May 2013
Bard Electrophysiology May 2012 - July 2012
AlloSource May 2011 - August 2011
Skills
Minitab, Matlab, Microsoft Office, Solidworks, Microsoft Excel, Cytotoxicity, Cell Culture, Teamwork, Catia, cGMP practices, cGMP manufacturing, Validation, Instrument Validation, Periodic Qualification..., Clean Rooms, Aseptic Technique, Medical Devices, Tensile Testing, 21 CFR Part 11, ASTM E2500, SolidWorks
Education
Purdue University 2009 — 2013
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY