Position:
Manager, Validation and Testing Services at ICON Clinical Research
Location:
Greater Philadelphia Area
Work:
ICON Clinical Research
since Jun 2012
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Manager, Validation and Testing Services
ICON Clinical Research
Sep 2008 - Jun 2012
-
Validation Engineer III
Validation Technologies, Inc.
Dec 2003 - Sep 2008
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Senior Project Leader
Validation Compliance Services, Inc.
Dec 2002 - Nov 2003
-
Project Manager (Consultant at DSM Pharmaceuticals)
BAYER (consultant)
Aug 2002 - Dec 2002
-
Validation Engineer
Immunex
Jul 2001 - Jul 2002
-
QA Manager
Immunex / Wyeth Biopharma
Sep 1999 - Jun 2001
-
Senior Validation Specialist
Glaxo Wellcome Biopharmaceuticals Inc.
Sep 1998 - Sep 1999
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Supervisor of Validation
Amgen
Aug 1997 - Sep 1998
-
Associate Manufacturing Engineer
Biogen
May 1996 - Aug 1997
-
Process Operator II
Education:
North Carolina State University 1991 - 1995
BS, Chemical Engineering
Skills:
21 CFR Part 11, Biotechnology, CAPA, Change Control, Chemical Engineering, Cleaning Validation, Compliance, Computer System Validation, CRO, Engineering, Engineers, FDA, cGMP, GMP, GxP, GCP, ISO, Life Sciences, Pharmaceuticals, Process Engineering, Process Validation, Quality Assurance, Quality Systems, Regulatory Requirements, SDLC, SOP, Sterilization, Technology Transfer, Testing, Test Methodologies, Vaccines, Validation, Sop, V&V, Quality System, Pharmaceutical Industry, Medical Devices, Lifesciences, EDC