John J Kazanecki

12820 56Th Ave north, Plymouth, MN 55442

Biotechnology

Independent Consultant
Consultant
Olympus
Senior Quality Engineer
Boston Scientific Sep 2012 - Dec 2012
Software Quality Engineer
Boehringer Ingelheim May 2012 - Jun 2012
Production Mentoring
Covance Central Laboratory Services Sa Jun 2011 - Apr 2012
Software Validation Test Engineer - Lims Transfer For Clincal Studies

Salem Community College 1987
Rutgers University 1984 - 1987
Rutgers University 1985
Salem College
Associates, Associate of Arts

Validation
Computer System Validation
Fda
V&V
Capa
Medical Devices
Quality System
Gmp
Iso 13485
21 Cfr Part 11
Quality Assurance
Software Quality Assurance
Testing
Lims
Gamp
Project Management
Pharmaceutical Industry
Sdlc
Quality Control
Glp
Change Control
Sop
Design Control
Manufacturing
Iso
Biotechnology
Quality Auditing
Quality Management
Software Documentation
Automation
Technical Writing
Gxp
Document Management
Regulatory Submissions
Iso 14971
Regulatory Affairs
Regulatory Requirements
Aseptic Processing
21 Cfr

English
Spanish
Russian

Independent Consultant
Jan 2013 to Jun 2013
Automated Systems Validation, and Regulatory
Arden Hills, MN
Sep 2012 to Dec 2012
Software Quality Engineer
Ben Venue Laboratories
Bedford, OH
May 2012 to Jun 2012
Covance Central Laboratory Services
Avon, IN
Jun 2011 to Apr 2012
SW Test Engineer LIMS Transfer
Mentor Corporation

Apr 2011 to Jun 2011
Laboratory Validation Engineer
MES) (PM
West Deptford, NJ
Oct 2010 to Jan 2011
Computer System Validation Engineer
Boston Scientific Corporation
Maple Grove, MN
2005 to Sep 2010
Project Manager / Software Quality Assurance
Independent

2005 to 2005
FDA Regulations Instructor
PDL
Fremont, CA
2005 to 2005
LIMS Validation Engineer (Lab)
Bristol Meyers Squibb
Syracuse, NY
2004 to 2005
Computer System Validation Engineer
Wyeth Laboratories
Richmond, VA
2004 to 2004
Project Manager LIMS Validation
Amgen

2003 to 2004
Computer System Validation Engineer
Centocor
Malvern, PA
2000 to 2001
Automation Validation Engineer
Saab

2000 to 2000
Software Validation Consultant
Computer Validation
Wilmington, DE
1998 to 1999
QA Tester, Astra Zeneca
Bayer Consumer Products Division
Morristown, NJ
1998 to 1998
Validation Engineer (PM)
Cephalon, Inc
Baltimore, MD
1997 to 1998
HVAC / BMS Validation Engineer
Hewlett-Packard
Palo Alto, CA
1996 to 1998
Project Manager LIMS Development
Clinical Research Organization
Plymouth Meeting, PA
1997 to 1997
IBAH CRO in Plymouth Meeting
Sanofi-Winthrop
McPherson, KS
1997 to 1997
Sr. Validation Engineer
Syntex

1995 to 1997
Automation Validation Engineer
Syntex
Astra, AB, CA
1995 to 1997
Validation Engineer
Honeywell, PA Honeywell, LLC
Seoul, KR
1996 to 1996
Sr. Validation Consultant
Johnson Yokogawa Corporation
Tokyo, JP
1996 to 1996
Sr. Computer Validation Engineer
McNeil Consumer Products
Fort Washington, PA
1996 to 1996
Computer Validation Engineer
Warner Lambert, Inc
Vega Baja, PR
1995 to 1996
Sr. Validation Engineer
Getinge AB

1994 to 1996
Computer/Equipment Validation Engineer
Regulatory and Computer Systems Validation PM, Red Cross National
Headquarters, WA
1992 to 1996
Sr. Computer Validation Consultant
Regulatory and Computer Systems Validation PM, Red Cross National
Washington, DC
1995 to 1995
LIMS Project Manager
Serono Laboratories
Randolph, MA
1994 to 1995
Sr. Validation Engineer
E.I. DuPont
Manati, Puerto Rico, US
1994 to 1995
Software Validation Engineer
P.E. Nelson
Cupertino, CA
1994 to 1994
Computer Validation LIMS Engineer
Computer Validation

1988 to 1993
LIMS Project Manager
Experience
Experience

Salem Community College
1987
AS in Computers
Rutgers University in New Brunswick
New Brunswick, NJ
1984 to 1985
Pharmacy