Validation Systems, Inc.
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Validation Systems, Inc. Employees
Employee
Years
Job
Industry
Michelle Hickey Michelle Hickey's Validation Systems, Inc. Experience 1994 - 1995
Job Senior Manager, Validation at Clovis Oncology
Industry Biotechnology
Experience
Clovis Oncology June 2014 - Present
Biopharmaceutical Consultant & Contractor September 2012 - May 2014
Mangan Inc. September 2011 - September 2012
Amgen May 2010 - July 2011
Amgen March 2004 - April 2010
Wyeth Biopharma 2001 - 2003
Antigenics 1998 - 2001
ValSource 1997 - 1998
Raytheon 1995 - 1997
Validation Systems, Inc. 1994 - 1995
Skills
Equipment Qualification, Cleaning Validation, Steaming Validation, Quality Auditing, Training, Change Control, Project Management, Technical Writing, Staff Management, Risk Assessment, FDA GMP, Regulatory Inspections, Quality Assurance, Validation, FDA, Aseptic Processing, Quality System, GMP, Inspection, GLP, GAMP, V&V, GxP, Biopharmaceuticals, CAPA, Pharmaceutical Industry, 21 CFR Part 11, Biotechnology, Quality Control, Clean Rooms, Fermentation, Microbiology, Trackwise, Lifesciences, Sterilization, cGMP practices, cGMP manufacturing, Purification, Technology Transfer, Environmental Monitoring, CIP, Computer System..., LIMS, Regulatory Requirements, Analytical Chemistry
Education
Rochester Institute of Technology 1989 — 1993
BS, Biotechnology
Clovis Oncology June 2014 - Present
Biopharmaceutical Consultant & Contractor September 2012 - May 2014
Mangan Inc. September 2011 - September 2012
Amgen May 2010 - July 2011
Amgen March 2004 - April 2010
Wyeth Biopharma 2001 - 2003
Antigenics 1998 - 2001
ValSource 1997 - 1998
Raytheon 1995 - 1997
Validation Systems, Inc. 1994 - 1995
Skills
Equipment Qualification, Cleaning Validation, Steaming Validation, Quality Auditing, Training, Change Control, Project Management, Technical Writing, Staff Management, Risk Assessment, FDA GMP, Regulatory Inspections, Quality Assurance, Validation, FDA, Aseptic Processing, Quality System, GMP, Inspection, GLP, GAMP, V&V, GxP, Biopharmaceuticals, CAPA, Pharmaceutical Industry, 21 CFR Part 11, Biotechnology, Quality Control, Clean Rooms, Fermentation, Microbiology, Trackwise, Lifesciences, Sterilization, cGMP practices, cGMP manufacturing, Purification, Technology Transfer, Environmental Monitoring, CIP, Computer System..., LIMS, Regulatory Requirements, Analytical Chemistry
Education
Rochester Institute of Technology 1989 — 1993
BS, Biotechnology
Audrey Prosser Audrey Prosser's Validation Systems, Inc. Experience 1994 - 1996
Job at Ventana Medical Systems
Industry Medical Devices
Experience
Ventana Medical Systems (a subsidary of Roche) March 2011 - Present
Byron Medical division of Mentor Corporation (a owned subsididary of Johnson & Johnson) August 2008 - April 2011
Xeridiem (formerly MRI Medical) 2011 - 2011
AMEC Biopharmaceuticals February 2006 - August 2008
Guidant 2004 - 2006
Allergan 1998 - 2004
Certified Facilities 1996 - 1998
Validation Systems, Inc. 1994 - 1996
Molecular Biosystems 1993 - 1994
Skyland Scientific 1992 - 1993
Skills
ISO 13485, Quality System, Cross-functional Team..., Quality Assurance, Validation, Change Control, Medical Devices, FDA, CAPA, Quality Auditing, Auditing, ISO, GMP, Quality Control, Sop, Leadership, V&V, Biotechnology, Continuous Improvement, Six Sigma, Lean Manufacturing, Manufacturing, Regulatory Requirements, SOP, Pharmaceutical Industry, 21 CFR Part 11, Technology Transfer, Regulatory Affairs, Life Sciences, GLP
Education
California State University-Dominguez Hills 1995 — 1997
MS, Quality Assurance
Harvey Mudd College 1985 — 1990
B.S, Applied Chemistry / General Engineering
Ventana Medical Systems (a subsidary of Roche) March 2011 - Present
Byron Medical division of Mentor Corporation (a owned subsididary of Johnson & Johnson) August 2008 - April 2011
Xeridiem (formerly MRI Medical) 2011 - 2011
AMEC Biopharmaceuticals February 2006 - August 2008
Guidant 2004 - 2006
Allergan 1998 - 2004
Certified Facilities 1996 - 1998
Validation Systems, Inc. 1994 - 1996
Molecular Biosystems 1993 - 1994
Skyland Scientific 1992 - 1993
Skills
ISO 13485, Quality System, Cross-functional Team..., Quality Assurance, Validation, Change Control, Medical Devices, FDA, CAPA, Quality Auditing, Auditing, ISO, GMP, Quality Control, Sop, Leadership, V&V, Biotechnology, Continuous Improvement, Six Sigma, Lean Manufacturing, Manufacturing, Regulatory Requirements, SOP, Pharmaceutical Industry, 21 CFR Part 11, Technology Transfer, Regulatory Affairs, Life Sciences, GLP
Education
California State University-Dominguez Hills 1995 — 1997
MS, Quality Assurance
Harvey Mudd College 1985 — 1990
B.S, Applied Chemistry / General Engineering
Laura Cribbins Laura Cribbins's Validation Systems, Inc. Experience 1993 - 1997
Job Principal at C2 Enterprises, Inc.
Industry Pharmaceuticals
Experience
C2 Enterprises, Inc. May 2013 - Present
ProPharma Group January 2010 - May 2013
NovaBay 2008 - May 2013
C2 Enterprises, Inc. October 1998 - March 2010
Chiron 2002 - 2005
Validation Systems, Inc. 1993 - 1997
The Cooper Companies 1984 - 1989
Skills
Technology Transfer, Program Management, Planning, Biotechnology, Validation, Medical Devices, Manufacturing, Cross-functional Team..., GMP, Pharmaceuticals, Life Sciences, FDA, cGMP, Project Planning, Process Development, Strategic Planning, Biopharmaceuticals, Contract Manufacturing, Team Building, Process Validation, Risk Management, Pharmaceutical Industry, V&V, Computer System..., GxP, Lifesciences, Drug Development, Clinical Development, Regulatory Submissions, Pharmaceutics
Education
Santa Clara University 1987 — 1990
MBA
University of California, Santa Cruz 1979 — 1984
BA, Biology/Biochemistry
C2 Enterprises, Inc. May 2013 - Present
ProPharma Group January 2010 - May 2013
NovaBay 2008 - May 2013
C2 Enterprises, Inc. October 1998 - March 2010
Chiron 2002 - 2005
Validation Systems, Inc. 1993 - 1997
The Cooper Companies 1984 - 1989
Skills
Technology Transfer, Program Management, Planning, Biotechnology, Validation, Medical Devices, Manufacturing, Cross-functional Team..., GMP, Pharmaceuticals, Life Sciences, FDA, cGMP, Project Planning, Process Development, Strategic Planning, Biopharmaceuticals, Contract Manufacturing, Team Building, Process Validation, Risk Management, Pharmaceutical Industry, V&V, Computer System..., GxP, Lifesciences, Drug Development, Clinical Development, Regulatory Submissions, Pharmaceutics
Education
Santa Clara University 1987 — 1990
MBA
University of California, Santa Cruz 1979 — 1984
BA, Biology/Biochemistry
Katherine Cahoon Katherine Cahoon's Validation Systems, Inc. Experience August 2014 - Present
Job Laboratory Specialist at Validation Systems, Inc.
Industry Biotechnology
Experience
Validation Systems, Inc. August 2014 - Present
Pepperdine University January 2014 - April 2014
Pepperdine University August 2012 - April 2014
Pepperdine University August 2012 - December 2013
Pepperdine University September 2011 - December 2011
Rural Supply Hardware August 2007 - August 2010
Skills
Biology, Chemistry, Creativity, Tutoring, Microsoft Office, Meeting Scheduling, General Office Work, Coordinating Events, Cashiering, Organization, Leadership, Phone Etiquette, Equestrian, Teamwork, Customer Service, Data Analysis
Education
Pepperdine University 2010 — 2014
Bachelor's Degree, Biology, General, cum laude
Los Gatos High School 2006 — 2010
High School Diploma
Validation Systems, Inc. August 2014 - Present
Pepperdine University January 2014 - April 2014
Pepperdine University August 2012 - April 2014
Pepperdine University August 2012 - December 2013
Pepperdine University September 2011 - December 2011
Rural Supply Hardware August 2007 - August 2010
Skills
Biology, Chemistry, Creativity, Tutoring, Microsoft Office, Meeting Scheduling, General Office Work, Coordinating Events, Cashiering, Organization, Leadership, Phone Etiquette, Equestrian, Teamwork, Customer Service, Data Analysis
Education
Pepperdine University 2010 — 2014
Bachelor's Degree, Biology, General, cum laude
Los Gatos High School 2006 — 2010
High School Diploma
Sedjenane Chang Sedjenane Chang's Validation Systems, Inc. Experience May 2004 - April 2006
Job International Board Certified Lactation Consultant at Back to Basics Parenting Services, LLC
Industry Biotechnology
Experience
Back to Basics Parenting Services, LLC May 2014 - Present
Abbott Vascular April 2006 - October 2009
Validation Systems, Inc. May 2004 - April 2006
Prime Engineering 2000 - 2001
Delta Air Lines 1996 - 1997
Education
Georgia Institute of Technology 1994 — 1999
BME, Mechanical Engineering
Alabama School of Math and Science
Back to Basics Parenting Services, LLC May 2014 - Present
Abbott Vascular April 2006 - October 2009
Validation Systems, Inc. May 2004 - April 2006
Prime Engineering 2000 - 2001
Delta Air Lines 1996 - 1997
Education
Georgia Institute of Technology 1994 — 1999
BME, Mechanical Engineering
Alabama School of Math and Science
Jeff Boldia's Validation Systems, Inc. Experience January 1997 - January 1998
Job Test Automation & QA/Test Solutions Architect at Cyber Consulting, Inc.
Industry Information Technology and Services
Experience
Cyber Consulting, Inc. January 1998 - Present
A large government contractor 2004 - 2007
Validation Systems, Inc. January 1997 - January 1998
Dow Chemical U.S.A. June 1988 - September 1988
Skills
LoadRunner, Quality Center, WinRunner, SAP, SiteScope, QTP, User Acceptance Testing, Testing, Test Director, SDLC, Telecommunications, Quality Assurance, Performance Testing, Requirements Analysis, Integration, Software Quality..., Performance Tuning, Software Project..., BSCS, SAP CRM, Worksoft Certify, SAP Portal, SAP R/3, SAP BW, SAP Netweaver, SAP BI, SAP ERP, SAP HR, SAP BaS, Recruiting, Talent Acquisition, Technical Recruiting, SAP TAO, SAP ECC, SAP SRM, SAP APO, SAP HCM, SAP EP, Performance Center, ALM, Training, ABAP, SAP Implementation, Data Migration, Test Management, Test Planning, System Testing
Education
Michigan State University 1984 — 1989
BSEE, Electrical Engineering, Graduated with honors: 3.5/4.0
Cyber Consulting, Inc. January 1998 - Present
A large government contractor 2004 - 2007
Validation Systems, Inc. January 1997 - January 1998
Dow Chemical U.S.A. June 1988 - September 1988
Skills
LoadRunner, Quality Center, WinRunner, SAP, SiteScope, QTP, User Acceptance Testing, Testing, Test Director, SDLC, Telecommunications, Quality Assurance, Performance Testing, Requirements Analysis, Integration, Software Quality..., Performance Tuning, Software Project..., BSCS, SAP CRM, Worksoft Certify, SAP Portal, SAP R/3, SAP BW, SAP Netweaver, SAP BI, SAP ERP, SAP HR, SAP BaS, Recruiting, Talent Acquisition, Technical Recruiting, SAP TAO, SAP ECC, SAP SRM, SAP APO, SAP HCM, SAP EP, Performance Center, ALM, Training, ABAP, SAP Implementation, Data Migration, Test Management, Test Planning, System Testing
Education
Michigan State University 1984 — 1989
BSEE, Electrical Engineering, Graduated with honors: 3.5/4.0
Chris Renz's Validation Systems, Inc. Experience 1996 - 1997
Job Global Packaging Development Manager
Industry Biotechnology
Experience
Genentech 2008 - Present
Genentech, Inc. 2001 - 2008
Self Employed 1998 - 2001
Oread 1997 - 1998
Validation Systems, Inc. 1996 - 1997
Skills
Management, Packaging Engineering, Cold Chain Shipping, Validation, Regulatory Submissions, Health Authority..., Risk Management, Negotiation, Public Speaking, Staff Development, Team Building, V&V, Medical Devices, Continuous Improvement, FDA, CAPA, Cross-functional Team..., Biotechnology, GxP, Quality System, GMP, Pharmaceutical Industry, Biopharmaceuticals
Education
University of San Francisco 2008 — 2011
BS, Applied Economics, 3.93 GPA
Genentech 2008 - Present
Genentech, Inc. 2001 - 2008
Self Employed 1998 - 2001
Oread 1997 - 1998
Validation Systems, Inc. 1996 - 1997
Skills
Management, Packaging Engineering, Cold Chain Shipping, Validation, Regulatory Submissions, Health Authority..., Risk Management, Negotiation, Public Speaking, Staff Development, Team Building, V&V, Medical Devices, Continuous Improvement, FDA, CAPA, Cross-functional Team..., Biotechnology, GxP, Quality System, GMP, Pharmaceutical Industry, Biopharmaceuticals
Education
University of San Francisco 2008 — 2011
BS, Applied Economics, 3.93 GPA
Jon Fuentes's Validation Systems, Inc. Experience November 1993 - Present
Job Principal at Validation Systems Inc
Industry Biotechnology
Experience
Validation Systems, Inc. November 1993 - Present
Fluor Daniel November 1991 - November 1993
United Engineers & Constructors October 1988 - October 1991
Skills
Validation, GMP, Software Documentation, V&V, Biotechnology, Sop, Manufacturing, Medical Devices, 21 CFR Part 11, FDA, Change Control, Auditing, CAPA, Computer System..., Quality System, ISO 13485, GxP, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick 1984 — 1988
Bachelor’s Degree, Electrical Engineering
Validation Systems, Inc. November 1993 - Present
Fluor Daniel November 1991 - November 1993
United Engineers & Constructors October 1988 - October 1991
Skills
Validation, GMP, Software Documentation, V&V, Biotechnology, Sop, Manufacturing, Medical Devices, 21 CFR Part 11, FDA, Change Control, Auditing, CAPA, Computer System..., Quality System, ISO 13485, GxP, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick 1984 — 1988
Bachelor’s Degree, Electrical Engineering
Diana Fan's Validation Systems, Inc. Experience September 2002 - May 2004
Job Validation Engineer
Industry Biotechnology
Experience
B. Braun Medical January 2009 - August 2012
B.Braun 2009 - August 2012
Cell Genesys January 2005 - October 2008
Cell Genesys May 2004 - January 2005
Validation Systems, Inc September 2002 - May 2004
Validation Systems, Inc. July 2002 - September 2002
Skills
GMP, Quality Assurance, Biotechnology, Project Management, CAPA, FDA, Validation
Education
University of California, Davis 1997 — 2002
BS, Chemical/Biochemical Engineering
B. Braun Medical January 2009 - August 2012
B.Braun 2009 - August 2012
Cell Genesys January 2005 - October 2008
Cell Genesys May 2004 - January 2005
Validation Systems, Inc September 2002 - May 2004
Validation Systems, Inc. July 2002 - September 2002
Skills
GMP, Quality Assurance, Biotechnology, Project Management, CAPA, FDA, Validation
Education
University of California, Davis 1997 — 2002
BS, Chemical/Biochemical Engineering
Samantha Hewer's Validation Systems, Inc. Experience 2000 - Present
Job Laboratory Manager at Validation Systems, Inc.
Industry Biotechnology
Experience
Validation Systems, Inc. 2000 - Present
Validation Systems, Inc. 1998 - 2000
Validation Systems, Inc. 1996 - 1998
Validation Systems, Inc. August 1995 - 1996
Santa Clara Valley Medical Center September 1991 - July 1995
University of Southern California September 1987 - July 1989
Skills
Validation, GMP, Sop, Aseptic Processing, Biopharmaceuticals, Cleaning Validation, FDA, Biotechnology, GLP, CAPA, Laboratory, Microbiology, SOP
Education
Chicago Medical School at Rosalind Franklin U-Med & Science 1989 — 1991
Graduate Certificate of Completion, Applied Physiology
Scripps College 1983 — 1987
B.A., Biology
Validation Systems, Inc. 2000 - Present
Validation Systems, Inc. 1998 - 2000
Validation Systems, Inc. 1996 - 1998
Validation Systems, Inc. August 1995 - 1996
Santa Clara Valley Medical Center September 1991 - July 1995
University of Southern California September 1987 - July 1989
Skills
Validation, GMP, Sop, Aseptic Processing, Biopharmaceuticals, Cleaning Validation, FDA, Biotechnology, GLP, CAPA, Laboratory, Microbiology, SOP
Education
Chicago Medical School at Rosalind Franklin U-Med & Science 1989 — 1991
Graduate Certificate of Completion, Applied Physiology
Scripps College 1983 — 1987
B.A., Biology
Eric Chalfin's Validation Systems, Inc. Experience August 1999 - November 2012
Job Manufacturing Engineer at Alphatec Spine
Industry Medical Devices
Experience
Alphatec Spine November 2012 - Present
Validation Systems, Inc. August 1999 - November 2012
Skills
Engineering, FDA, GMP, Medical Devices, Manufacturing, Validation, Biotechnology, CAPA, Testing
Education
University of Utah 1995 — 1998
Bioengineering and Biomedical Engineering
University of California, Berkeley 1992 — 1994
BS, Bioengineering
Foothill College 1989 — 1992
Engineering
Alphatec Spine November 2012 - Present
Validation Systems, Inc. August 1999 - November 2012
Skills
Engineering, FDA, GMP, Medical Devices, Manufacturing, Validation, Biotechnology, CAPA, Testing
Education
University of Utah 1995 — 1998
Bioengineering and Biomedical Engineering
University of California, Berkeley 1992 — 1994
BS, Bioengineering
Foothill College 1989 — 1992
Engineering
Demetra Wiltz-Schlant's Validation Systems, Inc. Experience August 2007 - March 2011
Job Laboratory Specialist
Industry Biotechnology
Experience
Schafer Corporation March 2011 - Present
Validation Systems, Inc. August 2007 - March 2011
North Valley Emergency Veterinary Clinic 2006 - 2007
Skills
Biotechnology, Laboratory, Quality Control, Chemistry, Science, Sop
Education
California State University-Chico 2002 — 2007
BS, Biological Sciences
Griffith University 2006 — 2006
Zoology/Animal Biology
Schafer Corporation March 2011 - Present
Validation Systems, Inc. August 2007 - March 2011
North Valley Emergency Veterinary Clinic 2006 - 2007
Skills
Biotechnology, Laboratory, Quality Control, Chemistry, Science, Sop
Education
California State University-Chico 2002 — 2007
BS, Biological Sciences
Griffith University 2006 — 2006
Zoology/Animal Biology
Margaret Wells's Validation Systems, Inc. Experience August 1994 - July 1996
Job
Industry Pharmaceuticals
Experience
Celgene June 2005 - Present
Merck May 2004 - June 2005
Merck December 2000 - May 2004
Merck December 1997 - December 2000
Merck March 1997 - December 1997
Validation Systems, Inc. August 1994 - July 1996
Skills
Regulatory Affairs, Vendor Management, FDA, Pharmaceutical Industry, Validation, Technology Transfer, 21 CFR Part 11, Change Management, GMP, Sop, Biotechnology, Computer System..., Management, CAPA, Quality Assurance, Change Control, Cross-functional Team..., SDLC, Process Improvement
Education
Columbia University - Fu Foundation School of Engineering and Applied Science 2000 — 2003
Masters of Science
Manhattan College 1991 — 1993
Bachelor of Engineering
Celgene June 2005 - Present
Merck May 2004 - June 2005
Merck December 2000 - May 2004
Merck December 1997 - December 2000
Merck March 1997 - December 1997
Validation Systems, Inc. August 1994 - July 1996
Skills
Regulatory Affairs, Vendor Management, FDA, Pharmaceutical Industry, Validation, Technology Transfer, 21 CFR Part 11, Change Management, GMP, Sop, Biotechnology, Computer System..., Management, CAPA, Quality Assurance, Change Control, Cross-functional Team..., SDLC, Process Improvement
Education
Columbia University - Fu Foundation School of Engineering and Applied Science 2000 — 2003
Masters of Science
Manhattan College 1991 — 1993
Bachelor of Engineering