The Validation Group
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The Validation Group Employees
Employee
Years
Job
Industry
Bruce Huval Bruce Huval's The Validation Group Experience 1997 - 2001
Job Owner, Compli, LLC
Industry Pharmaceuticals
Experience
Compli, LLC January 2001 - Present
The Validation Group 1997 - 2001
Jacobs Engineering, Inc. 1995 - 1997
Raytheon Engineers and Constructors 1990 - 1995
Skills
Project Management, Automation, Start-ups, Quality Assurance, Business Development, GMP, Technology Transfer, Validation, Pharmaceutical Industry, FDA, Team Building, New Business Development, Cross-functional Team..., Testing, Medical Devices, Quality System, Sop, Change Control, Computer System..., 21 CFR Part 11, Process Simulation, Biotechnology, Process Improvement, Quality Auditing, ISO 13485, Quality Control, V&V, Lifesciences, Pharmaceutics, Regulatory Affairs, Software Documentation, CAPA, Program Management, Quality Management, R&D, Process Engineering, Document Management, SOP
Education
Southeastern Louisiana University
Bachelor's of Science
Compli, LLC January 2001 - Present
The Validation Group 1997 - 2001
Jacobs Engineering, Inc. 1995 - 1997
Raytheon Engineers and Constructors 1990 - 1995
Skills
Project Management, Automation, Start-ups, Quality Assurance, Business Development, GMP, Technology Transfer, Validation, Pharmaceutical Industry, FDA, Team Building, New Business Development, Cross-functional Team..., Testing, Medical Devices, Quality System, Sop, Change Control, Computer System..., 21 CFR Part 11, Process Simulation, Biotechnology, Process Improvement, Quality Auditing, ISO 13485, Quality Control, V&V, Lifesciences, Pharmaceutics, Regulatory Affairs, Software Documentation, CAPA, Program Management, Quality Management, R&D, Process Engineering, Document Management, SOP
Education
Southeastern Louisiana University
Bachelor's of Science
Bharti Desai Bharti Desai's The Validation Group Experience May 1996 - June 1998
Job Associate Director, Johnson & Johnson Pharmaceutical Research & Development
Industry Biotechnology
Experience
Johnson & Johnson Pharmaceutical Research & Development January 2014 - Present
Johnson & Johnson Pharmaceutical Research & Development January 2010 - Present
Centocor June 2008 - December 2009
Centocor February 2007 - June 2008
Centocor June 2005 - February 2007
Merck December 1998 - June 2005
The Validation Group May 1996 - June 1998
Millipore Corporation 1995 - 1996
Cellcor Inc. 1992 - 1995
Skills
Process Validation, Technology Transfer, Validation, Regulatory Submissions, Online Communications, Process Engineering, Formulation Development, GMP, cGMP, Biotechnology, SOP, Cell Culture, Purification, Process Development, Vaccines, R&D, CAPA, Quality Assurance, GLP, Compliance, Manufacturing, Medical Devices, Biopharmaceuticals, Biochemistry, Continuous Improvement, Product Development, Aseptic Processing, Documentation, People Management, Sop
Education
Lehigh University 1999 — 2001
MS, Quality Engineering
University of Massachusetts Lowell 1989 — 1992
Johnson & Johnson Pharmaceutical Research & Development January 2014 - Present
Johnson & Johnson Pharmaceutical Research & Development January 2010 - Present
Centocor June 2008 - December 2009
Centocor February 2007 - June 2008
Centocor June 2005 - February 2007
Merck December 1998 - June 2005
The Validation Group May 1996 - June 1998
Millipore Corporation 1995 - 1996
Cellcor Inc. 1992 - 1995
Skills
Process Validation, Technology Transfer, Validation, Regulatory Submissions, Online Communications, Process Engineering, Formulation Development, GMP, cGMP, Biotechnology, SOP, Cell Culture, Purification, Process Development, Vaccines, R&D, CAPA, Quality Assurance, GLP, Compliance, Manufacturing, Medical Devices, Biopharmaceuticals, Biochemistry, Continuous Improvement, Product Development, Aseptic Processing, Documentation, People Management, Sop
Education
Lehigh University 1999 — 2001
MS, Quality Engineering
University of Massachusetts Lowell 1989 — 1992
Jay Goldberg Jay Goldberg's The Validation Group Experience September 1998 - November 2001
Job Chief Financial Officer at Compli. LLC
Industry Pharmaceuticals
Experience
Compli. LLC December 2001 - Present
The Validation Group September 1998 - November 2001
Avellino's Tire & Auto Centers January 1991 - September 1998
Skills
Financial Analysis, Forecasting, Financial Reporting, Managerial Finance, Financial Modeling, Accounting, Internal Controls, Strategic Financial..., Corporate Finance, Budgets, Finance, Business Planning
Education
Drexel University - College of Business and Administration 1994 — 1996
Master of Business Administration (M.B.A.), Accounting Control
Muhlenberg College 1985 — 1989
Bachelor of Arts (B.A.)
Compli. LLC December 2001 - Present
The Validation Group September 1998 - November 2001
Avellino's Tire & Auto Centers January 1991 - September 1998
Skills
Financial Analysis, Forecasting, Financial Reporting, Managerial Finance, Financial Modeling, Accounting, Internal Controls, Strategic Financial..., Corporate Finance, Budgets, Finance, Business Planning
Education
Drexel University - College of Business and Administration 1994 — 1996
Master of Business Administration (M.B.A.), Accounting Control
Muhlenberg College 1985 — 1989
Bachelor of Arts (B.A.)
Evan Cutler Evan Cutler's The Validation Group Experience February 1997 - February 1998
Job Managing Director at Cutler Solutions, LLC
Industry Pharmaceuticals
Experience
Cutler Solutions, LLC January 2012 - Present
Meridan Consulting, LLC June 2011 - Present
MonoSol Rx, LLC September 2014 - July 2015
MonoSol Rx November 2012 - February 2014
Johnson & Johnson - Noramco, Inc. March 2007 - November 2012
VTS Consultants, Inc. February 1998 - November 2012
The Validation Group February 1997 - February 1998
FDA July 1990 - February 1996
Skills
Quality Assurance, Validation, FDA, Change Control, CAPA, GMP, Pharmaceutical Industry, 21 CFR Part 11, Quality System, V&V, Regulatory Affairs, Computer System..., Medical Devices, Regulatory Submissions, GAMP, Biopharmaceuticals, Quality Auditing, Regulatory Requirements, ISO, Pharmaceutics, Biotechnology, ISO 13485, GLP, Quality Control, SOP, Auditing, Risk Assessment, Quality Management, Software Documentation, Management, Packaging, Design Control, Documentation, Qualification Testing, Lifesciences, Quality Systems, cGMP, Pharmaceuticals, Compliance, Investigations, Process Validation
Education
Rutgers, The State University of New Jersey-New Brunswick 1986 — 1990
Bachelor, Biology
Cherry Hill High School East 1982 — 1986
Diploma
Cutler Solutions, LLC January 2012 - Present
Meridan Consulting, LLC June 2011 - Present
MonoSol Rx, LLC September 2014 - July 2015
MonoSol Rx November 2012 - February 2014
Johnson & Johnson - Noramco, Inc. March 2007 - November 2012
VTS Consultants, Inc. February 1998 - November 2012
The Validation Group February 1997 - February 1998
FDA July 1990 - February 1996
Skills
Quality Assurance, Validation, FDA, Change Control, CAPA, GMP, Pharmaceutical Industry, 21 CFR Part 11, Quality System, V&V, Regulatory Affairs, Computer System..., Medical Devices, Regulatory Submissions, GAMP, Biopharmaceuticals, Quality Auditing, Regulatory Requirements, ISO, Pharmaceutics, Biotechnology, ISO 13485, GLP, Quality Control, SOP, Auditing, Risk Assessment, Quality Management, Software Documentation, Management, Packaging, Design Control, Documentation, Qualification Testing, Lifesciences, Quality Systems, cGMP, Pharmaceuticals, Compliance, Investigations, Process Validation
Education
Rutgers, The State University of New Jersey-New Brunswick 1986 — 1990
Bachelor, Biology
Cherry Hill High School East 1982 — 1986
Diploma
Peter Buxton Peter Buxton's The Validation Group Experience 1996 - 1998
Job Enterprise Risk & Compliance Lead at GSK
Industry Pharmaceuticals
Experience
GSK June 2014 - Present
GlaxoSmithKline February 2008 - Present
GlaxoSmithKline June 2003 - February 2008
GSK 2001 - 2004
GlaxoSmithKline 1998 - 2001
The Validation group 1996 - 1998
Skills
Technology Transfer, R&D, GMP, Engineering, Validation, Biopharmaceuticals, Vaccines, Facilities Management, Medical Devices, Project Management, Six Sigma, Sterilization, CAPA, Manufacturing, Sop, Leadership, FDA, GAMP, Change Control, Pharmaceutical Industry, Aseptic Technique, Quality Assurance, 21 CFR Part 11, Regulatory Affairs, GxP, Quality System, SOP, Trackwise, Computer System..., Cleaning Validation, V&V, Regulatory Requirements, Drug Development, Regulatory Submissions, Biotechnology, GLP, Aseptic Processing, Clinical Development, LIMS
Education
Penn State University
The University of Manchester
Master of Science (MSc)
GSK June 2014 - Present
GlaxoSmithKline February 2008 - Present
GlaxoSmithKline June 2003 - February 2008
GSK 2001 - 2004
GlaxoSmithKline 1998 - 2001
The Validation group 1996 - 1998
Skills
Technology Transfer, R&D, GMP, Engineering, Validation, Biopharmaceuticals, Vaccines, Facilities Management, Medical Devices, Project Management, Six Sigma, Sterilization, CAPA, Manufacturing, Sop, Leadership, FDA, GAMP, Change Control, Pharmaceutical Industry, Aseptic Technique, Quality Assurance, 21 CFR Part 11, Regulatory Affairs, GxP, Quality System, SOP, Trackwise, Computer System..., Cleaning Validation, V&V, Regulatory Requirements, Drug Development, Regulatory Submissions, Biotechnology, GLP, Aseptic Processing, Clinical Development, LIMS
Education
Penn State University
The University of Manchester
Master of Science (MSc)
Alicia Luna's The Validation Group Experience 1997 - 2001
Job Consultant
Industry Pharmaceuticals
Experience
Pharmaceutical Industry January 2011 - Present
Pfizer (formerly Wyeth) January 2009 - June 2010
Wyeth November 2007 - December 2008
Wyeth November 2006 - November 2007
Wyeth November 2004 - November 2006
Jacobs Engineering January 2003 - November 2004
Pharma-Bio Serv 2001 - 2002
The Validation Group 1997 - 2001
Bristol-Myers Squibb 1997 - 2000
Skills
Validation, Computer System..., GMP, CAPA, Change Control, 21 CFR Part 11, Sop, GxP, FDA, V&V, Quality System, GAMP, Biotechnology, Manufacturing, Biopharmaceuticals, Pharmaceutical Industry, Medical Devices, LIMS, Quality Assurance, Pharmaceutics, ISO 13485, Process Improvement, Cleaning Validation, GLP, Technology Transfer, Lifesciences, Process Simulation, Six Sigma, Continuous Improvement, Process Engineering, Regulatory Affairs, Quality Control, Aseptic Processing, Cross-functional Team..., Software Documentation, Operational Excellence, Document Management, Quality Management, Design of Experiments, Quality Auditing, Regulatory Requirements, Regulatory Submissions, ISO, MES, Root Cause Analysis, R&D, Vaccines, Analytical Chemistry, DMAIC, GCP
Education
Universidad Politécnica de Puerto Rico 1992 — 1997
BS, Industrial Engineering
Pharmaceutical Industry January 2011 - Present
Pfizer (formerly Wyeth) January 2009 - June 2010
Wyeth November 2007 - December 2008
Wyeth November 2006 - November 2007
Wyeth November 2004 - November 2006
Jacobs Engineering January 2003 - November 2004
Pharma-Bio Serv 2001 - 2002
The Validation Group 1997 - 2001
Bristol-Myers Squibb 1997 - 2000
Skills
Validation, Computer System..., GMP, CAPA, Change Control, 21 CFR Part 11, Sop, GxP, FDA, V&V, Quality System, GAMP, Biotechnology, Manufacturing, Biopharmaceuticals, Pharmaceutical Industry, Medical Devices, LIMS, Quality Assurance, Pharmaceutics, ISO 13485, Process Improvement, Cleaning Validation, GLP, Technology Transfer, Lifesciences, Process Simulation, Six Sigma, Continuous Improvement, Process Engineering, Regulatory Affairs, Quality Control, Aseptic Processing, Cross-functional Team..., Software Documentation, Operational Excellence, Document Management, Quality Management, Design of Experiments, Quality Auditing, Regulatory Requirements, Regulatory Submissions, ISO, MES, Root Cause Analysis, R&D, Vaccines, Analytical Chemistry, DMAIC, GCP
Education
Universidad Politécnica de Puerto Rico 1992 — 1997
BS, Industrial Engineering
Michael Koss Michael Koss's The Validation Group Experience October 2000 - July 2002
Job Pharma/biopharm professional; diverse experience in project management, validation, manuf. equip./controls and QA
Industry Biotechnology
Experience
GSK - GlaxoSmithKline November 2008 - Present
Neuronyx Inc June 2006 - June 2007
IPS-Integrated Project Services, Inc. August 2002 - June 2006
The Validation Group October 2000 - July 2002
Waltron, Ltd., Aqualert Division October 1999 - October 2000
Aerotek Inc. April 1997 - October 1999
Skills
Equipment Validation, Technical Support, Quality Assurance, Project Management, Engineering, FDA, cGMP manufacturing, cGMP practices, Process Validation, CAPA, Aseptic Processing, Change Control, GMP, Chemical Engineering, SOP Development, IQ/OQ, PQ, Pharmaceutical Industry, Biopharmaceuticals, 21 CFR Parts 210/211, Project Leadership
Education
University of Pittsburgh 1992 — 1997
Bachelor of Science (BS), Chemical Engineering
GSK - GlaxoSmithKline November 2008 - Present
Neuronyx Inc June 2006 - June 2007
IPS-Integrated Project Services, Inc. August 2002 - June 2006
The Validation Group October 2000 - July 2002
Waltron, Ltd., Aqualert Division October 1999 - October 2000
Aerotek Inc. April 1997 - October 1999
Skills
Equipment Validation, Technical Support, Quality Assurance, Project Management, Engineering, FDA, cGMP manufacturing, cGMP practices, Process Validation, CAPA, Aseptic Processing, Change Control, GMP, Chemical Engineering, SOP Development, IQ/OQ, PQ, Pharmaceutical Industry, Biopharmaceuticals, 21 CFR Parts 210/211, Project Leadership
Education
University of Pittsburgh 1992 — 1997
Bachelor of Science (BS), Chemical Engineering
Denise Gilchrist, PMP Denise Gilchrist, PMP's The Validation Group Experience July 1995 - July 1997
Job Project Manager, Technical Writer and Entrepreneur
Industry Pharmaceuticals
Experience
Lonicera Consulting Services, Inc. February 2015 - Present
Zalda Technology October 2014 - Present
Lernia Training Solutions June 2014 - September 2014
Teva Pharmaceuticals, Inc. January 2012 - May 2014
Cephalon, Inc January 2011 - December 2011
Cephalon, Inc. May 2005 - December 2010
Sanofi-Aventis January 2000 - May 2005
Merck Research Laboratories January 1998 - December 1999
Validation and Process Associates July 1997 - December 1997
The Validation Group July 1995 - July 1997
Skills
Certified Project..., Lifesciences, Technical Writing, GMP, 21 CFR Part 11, CMC Regulatory Affairs, Process Improvement, Process Validation, V&V, Contract Manufacturing, Report Writing, Communication, Relationship Building, Interpersonal Skills, Membership Relations, Museum Education, Field Botany, Native Plants, Fitness Instruction, Holistic Health, Life Sciences, SOP, Pharmaceutical Industry, Validation, Project Management, Biotechnology, Cross-functional Team..., Management
Education
Pennsylvania State University-Great Valley Graduate Center 2008 — 2010
Graduate Certificate, Instructional Systems for E-learning
Pennsylvania State University-Great Valley Graduate Center 2002 — 2002
Certificate, Project Management
Temple University 1989 — 1992
BS, Horticulture (Plant Science), GPA 3.69
Lonicera Consulting Services, Inc. February 2015 - Present
Zalda Technology October 2014 - Present
Lernia Training Solutions June 2014 - September 2014
Teva Pharmaceuticals, Inc. January 2012 - May 2014
Cephalon, Inc January 2011 - December 2011
Cephalon, Inc. May 2005 - December 2010
Sanofi-Aventis January 2000 - May 2005
Merck Research Laboratories January 1998 - December 1999
Validation and Process Associates July 1997 - December 1997
The Validation Group July 1995 - July 1997
Skills
Certified Project..., Lifesciences, Technical Writing, GMP, 21 CFR Part 11, CMC Regulatory Affairs, Process Improvement, Process Validation, V&V, Contract Manufacturing, Report Writing, Communication, Relationship Building, Interpersonal Skills, Membership Relations, Museum Education, Field Botany, Native Plants, Fitness Instruction, Holistic Health, Life Sciences, SOP, Pharmaceutical Industry, Validation, Project Management, Biotechnology, Cross-functional Team..., Management
Education
Pennsylvania State University-Great Valley Graduate Center 2008 — 2010
Graduate Certificate, Instructional Systems for E-learning
Pennsylvania State University-Great Valley Graduate Center 2002 — 2002
Certificate, Project Management
Temple University 1989 — 1992
BS, Horticulture (Plant Science), GPA 3.69
Barry DeDominicis Barry DeDominicis's The Validation Group Experience March 2000 - August 2000
Job Associate Director, CMO Serialization, BMS
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb July 2012 - Present
Bracco Diagnostic Inc September 2003 - July 2012
Elan Pharmaceuticals August 2000 - May 2003
The Validation Group March 2000 - August 2000
Martech/MDI January 1998 - January 2000
ESI Lederle January 1997 - January 1998
The Liposome Company, Inc January 1995 - January 1997
The Liposome Company, Inc. 1995 - 1997
Nutra-Max Corporation (Optopics) January 1993 - January 1995
Luitpold Pharmaceuticals, Inc January 1992 - January 1993
Skills
Serialization, GMP, Validation, FDA, Sop, Technology Transfer, Pharmaceutical Industry, Contract Manufacturing, Aseptic Processing, Change Control, Manufacturing, Quality Assurance, Process Improvement, CAPA, Budgets, V&V, Biotechnology, Pharmaceutics, Biopharmaceuticals, Process Simulation, Formulation, Contract Negotiation, Medical Devices, 21 CFR Part 11, Quality Management, ANDA, Clinical Development, Quality Control, Clinical Trials, Cleaning Validation, Regulatory Affairs, Quality System, GLP, IND, Troubleshooting, Outsourcing, Pharmaceuticals, Regulatory Requirements, Regulatory Submissions, Six Sigma, Lyophilization, Computer System..., cGMP, Budgeting, Process Validation, CMO management, Consulting, Contract Negotiations, Generics, Process Development
Education
Penn State University 1984 — 1989
1989, Operations
Penn State University 1984 — 1989
Bachelor's degree, Operation's Management
Neshaminy High School 1976 — 1979
Bristol-Myers Squibb July 2012 - Present
Bracco Diagnostic Inc September 2003 - July 2012
Elan Pharmaceuticals August 2000 - May 2003
The Validation Group March 2000 - August 2000
Martech/MDI January 1998 - January 2000
ESI Lederle January 1997 - January 1998
The Liposome Company, Inc January 1995 - January 1997
The Liposome Company, Inc. 1995 - 1997
Nutra-Max Corporation (Optopics) January 1993 - January 1995
Luitpold Pharmaceuticals, Inc January 1992 - January 1993
Skills
Serialization, GMP, Validation, FDA, Sop, Technology Transfer, Pharmaceutical Industry, Contract Manufacturing, Aseptic Processing, Change Control, Manufacturing, Quality Assurance, Process Improvement, CAPA, Budgets, V&V, Biotechnology, Pharmaceutics, Biopharmaceuticals, Process Simulation, Formulation, Contract Negotiation, Medical Devices, 21 CFR Part 11, Quality Management, ANDA, Clinical Development, Quality Control, Clinical Trials, Cleaning Validation, Regulatory Affairs, Quality System, GLP, IND, Troubleshooting, Outsourcing, Pharmaceuticals, Regulatory Requirements, Regulatory Submissions, Six Sigma, Lyophilization, Computer System..., cGMP, Budgeting, Process Validation, CMO management, Consulting, Contract Negotiations, Generics, Process Development
Education
Penn State University 1984 — 1989
1989, Operations
Penn State University 1984 — 1989
Bachelor's degree, Operation's Management
Neshaminy High School 1976 — 1979
Regina Haney Pharis's The Validation Group Experience 1996 - 2000
Job Quality Engineer at DPT , Lakewood, NJ
Industry Pharmaceuticals
Experience
DPT , Lakewood, NJ January 2013 - Present
PDA (Parenteral Drug Association) October 2011 - Present
WePresent October 2010 - Present
The Validation Group 1996 - 2000
PACO Pharmaceuticals 1993 - 1996
Paco Pharmaceutical 1991 - 1993
Skills
Validation, GMP, Sop, V&V, Manufacturing, FDA, 21 CFR Part 11, Change Control, CAPA, Pharmaceutical Industry, GxP, Computer System..., GLP, Cleaning Validation, Aseptic Processing, Biotechnology, Technology Transfer, Quality System, GAMP, Lifesciences, Biopharmaceuticals, ISO 13485
Education
Saint Bonaventure University 1987 — 1991
BS, Chemistry
DPT , Lakewood, NJ January 2013 - Present
PDA (Parenteral Drug Association) October 2011 - Present
WePresent October 2010 - Present
The Validation Group 1996 - 2000
PACO Pharmaceuticals 1993 - 1996
Paco Pharmaceutical 1991 - 1993
Skills
Validation, GMP, Sop, V&V, Manufacturing, FDA, 21 CFR Part 11, Change Control, CAPA, Pharmaceutical Industry, GxP, Computer System..., GLP, Cleaning Validation, Aseptic Processing, Biotechnology, Technology Transfer, Quality System, GAMP, Lifesciences, Biopharmaceuticals, ISO 13485
Education
Saint Bonaventure University 1987 — 1991
BS, Chemistry