Position:
Owner, Validation Consultant at Stewart Technical Services, LLC
Work:
Stewart Technical Services, LLC
since May 2010
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Owner, Validation Consultant
Zymogenetics, A Bristol-Meyers Squibb Company
Jun 2011 - Sep 2011
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QA Contractor
CMC ICOS Biologics, Inc
Dec 2007 - Jan 2010
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Validation Manager
ICOS Corporation
Nov 2003 - Nov 2007
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QA Validation Programs Manager
various Pharma/Biotech companies
Dec 1999 - Oct 2003
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Validation Contractor
GensiaSicor Corporation
Feb 1999 - Nov 1999
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Sr. Validation Engineer
Alpha Therapeutic Corporation
Feb 1997 - Oct 1998
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Validation Engineer III
NeXstar Pharmaceuticals, Inc
Apr 1993 - Dec 1996
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Process Development Engineer
Mentor H/S
Sep 1992 - Mar 1993
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Research and Development Engineer
Education:
Villanova University 2002
Certificate, Project Management
University of California, Santa Barbara 1987 - 1992
B.S., Chemical Engineering
Barstow High School
Skills:
Computer System Validation, Quality Assurance, GMP, ICH Q7, ICH Q9, 21 CFR Part 11, Validation, Change Management, Risk Management, Equipment Validation, Technical Writing, Validation Master Plans, Utility Validation, CAPA, Deviations, V&V, GxP, FDA, Biotechnology, Process Simulation
Interests:
Quality, Validation, Chemical Engineering
Volunteer at Sizzleworks Cooking School
Honor & Awards:
Icosahedron Achievement Award -- Icos Corporation