Invensys Validation Technologies
Industry: Company
DescriptionFounded: 1994 Parent organization: Invensys Limited
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Invensys Validation Technologies Employees
Employee
Years
Job
Industry
Justin Self Justin Self's Invensys Validation Technologies Experience July 2002 - July 2003
Job Performance Improvement Engineer at BarnesJewish Hospital
Industry Hospital & Health Care
Experience
Barnes-Jewish Hospital July 2013 - Present
Monsanto February 2010 - July 2013
Eli Lilly July 2003 - January 2010
Rose-Hulman Institute of Technology March 2009 - May 2009
Invensys Validation Technologies July 2002 - July 2003
Sigma Aldrich June 2001 - August 2001
Skills
Quality Management, Business Process..., Operational Excellence, Project Portfolio..., Process Management, Continuous Improvement..., Change Management, Project Management, Six Sigma, Green Belt, DMAIC, Process Simulation, Process Capability, Change Control, Engineering Management, Mentoring, Coaching, Lean Manufacturing, Manufacturing..., Team Facilitation, Team Leadership, Strategic Planning, Kepner-Tregoe, Variation Reduction, Process Analysis, Business Process Mapping, Root Cause Analysis, Complaint Investigations, FDA GMP, Validation Master Plans, Quality Investigations, Manufacturing Operations, Process Design, Capacity Planning, ASQ Member, iGrafx, Deviation Management, Process Improvement, Cross-functional Team...
Education
Rose-Hulman Institute of Technology
BS, Chemical Engineering
Rose-Hulman Institute of Technology
MS, Engineering Management
Barnes-Jewish Hospital July 2013 - Present
Monsanto February 2010 - July 2013
Eli Lilly July 2003 - January 2010
Rose-Hulman Institute of Technology March 2009 - May 2009
Invensys Validation Technologies July 2002 - July 2003
Sigma Aldrich June 2001 - August 2001
Skills
Quality Management, Business Process..., Operational Excellence, Project Portfolio..., Process Management, Continuous Improvement..., Change Management, Project Management, Six Sigma, Green Belt, DMAIC, Process Simulation, Process Capability, Change Control, Engineering Management, Mentoring, Coaching, Lean Manufacturing, Manufacturing..., Team Facilitation, Team Leadership, Strategic Planning, Kepner-Tregoe, Variation Reduction, Process Analysis, Business Process Mapping, Root Cause Analysis, Complaint Investigations, FDA GMP, Validation Master Plans, Quality Investigations, Manufacturing Operations, Process Design, Capacity Planning, ASQ Member, iGrafx, Deviation Management, Process Improvement, Cross-functional Team...
Education
Rose-Hulman Institute of Technology
BS, Chemical Engineering
Rose-Hulman Institute of Technology
MS, Engineering Management
Leonard Smyth Leonard Smyth's Invensys Validation Technologies Experience September 1996 - January 2009
Job Managing Consultant, Compliance Consulting at Schneider Electric
Industry Pharmaceuticals
Experience
Schneider Electric September 1996 - Present
Invensys September 2001 - January 2014
Invensys Validation Technologies September 1996 - January 2009
Eli Lilly Canada September 1991 - September 1996
Janssen-Ortho January 1983 - September 1987
Skills
PMP, 21 CFR Part 11, Project Management, Computer System..., Pharmaceutical Industry, SAP R/3, LIMS, Quality Management, Quality Assurance, GAMP, GMP, FDA GMP, Validation, Commissioning, Qualification Testing, Business Development, Document Management, ERP Implementations, ERP Selection, SDLC, Quality System, Infrastructure, Change Control, FDA, V&V, GxP, Strategy, Cross-functional Team..., Biopharmaceuticals, Process Improvement, Biotechnology, Process Simulation, ERP, Process Engineering, Sop, MES, Change Management, Manufacturing, Six Sigma, Automation, Process Control, Regulatory Affairs, Software Documentation, Technology Transfer, Continuous Improvement, Process Automation
Education
University of Waterloo 1983 — 1987
B. Sc, Biology and Chemistry
Durham College
Project management
Schneider Electric September 1996 - Present
Invensys September 2001 - January 2014
Invensys Validation Technologies September 1996 - January 2009
Eli Lilly Canada September 1991 - September 1996
Janssen-Ortho January 1983 - September 1987
Skills
PMP, 21 CFR Part 11, Project Management, Computer System..., Pharmaceutical Industry, SAP R/3, LIMS, Quality Management, Quality Assurance, GAMP, GMP, FDA GMP, Validation, Commissioning, Qualification Testing, Business Development, Document Management, ERP Implementations, ERP Selection, SDLC, Quality System, Infrastructure, Change Control, FDA, V&V, GxP, Strategy, Cross-functional Team..., Biopharmaceuticals, Process Improvement, Biotechnology, Process Simulation, ERP, Process Engineering, Sop, MES, Change Management, Manufacturing, Six Sigma, Automation, Process Control, Regulatory Affairs, Software Documentation, Technology Transfer, Continuous Improvement, Process Automation
Education
University of Waterloo 1983 — 1987
B. Sc, Biology and Chemistry
Durham College
Project management
Jocelyn Zephrani Jocelyn Zephrani's Invensys Validation Technologies Experience 2007 - 2008
Job Quality Initiatives Inc. Principal Consultant
Industry Biotechnology
Experience
Novartis September 2012 - Present
Quality Initiatives Inc. 2006 - Present
Sanofi 2011 - 2012
The Hospital for Sick Children 2010 - 2011
DEMO Pharmaceuticals S.A. 2010 - 2010
Invensys Validation Technologies 2007 - 2008
Deb Canada (DEB Worldwide Heathcare Inc.) 2006 - 2007
SNC-Lavalin 2003 - May 2006
Bio-Technology General 2000 - 2003
Bio-Technology General 1997 - 2000
Skills
Traceability Matrix, Smoke Testing, CAPA, Validation, Aseptic Processing, Clean Rooms, Gap Analysis, Technical Writing, V&V, Protocol, Medical Devices, Quality Management, 21 CFR Part 11, GAMP, Change Control, FDA, GMP, GLP, Biopharmaceuticals, Equipment Qualification, Sop, Quality System, ISO 13485, Quality Auditing, Pharmaceutical Industry, Biotechnology, Pharmaceutics, Root Cause Analysis, Quality by Design, ISO 14971, Regulatory Requirements, Quality Assurance, Regulatory Affairs, GxP, Computer System..., Risk Assessment, Quality Control, Vaccines, Manufacturing, Process Simulation, Lifesciences, Cleaning Validation, R&D, Calibration, LIMS, Commissioning, Regulatory Submissions, Document Management, Life Sciences, SOP
Education
University of Haifa
Novartis September 2012 - Present
Quality Initiatives Inc. 2006 - Present
Sanofi 2011 - 2012
The Hospital for Sick Children 2010 - 2011
DEMO Pharmaceuticals S.A. 2010 - 2010
Invensys Validation Technologies 2007 - 2008
Deb Canada (DEB Worldwide Heathcare Inc.) 2006 - 2007
SNC-Lavalin 2003 - May 2006
Bio-Technology General 2000 - 2003
Bio-Technology General 1997 - 2000
Skills
Traceability Matrix, Smoke Testing, CAPA, Validation, Aseptic Processing, Clean Rooms, Gap Analysis, Technical Writing, V&V, Protocol, Medical Devices, Quality Management, 21 CFR Part 11, GAMP, Change Control, FDA, GMP, GLP, Biopharmaceuticals, Equipment Qualification, Sop, Quality System, ISO 13485, Quality Auditing, Pharmaceutical Industry, Biotechnology, Pharmaceutics, Root Cause Analysis, Quality by Design, ISO 14971, Regulatory Requirements, Quality Assurance, Regulatory Affairs, GxP, Computer System..., Risk Assessment, Quality Control, Vaccines, Manufacturing, Process Simulation, Lifesciences, Cleaning Validation, R&D, Calibration, LIMS, Commissioning, Regulatory Submissions, Document Management, Life Sciences, SOP
Education
University of Haifa
Muhannad Zainy Muhannad Zainy's Invensys Validation Technologies Experience December 2006 - February 2010
Job Validation/Quality Consultant at Self Employed
Industry Biotechnology
Experience
ProPharma Group March 2015 - Present
Self Employed October 2014 - March 2015
Bio-Rad Laboratories March 2011 - September 2014
Self-Employed July 2010 - March 2011
Foster Wheeler Biokinetics March 2010 - June 2010
Invensys Validation Technologies December 2006 - February 2010
2006Barry Wehmiller Design Group April 2006 - December 2006
AVI BioPharma January 2004 - April 2006
AVI BioPharma July 2002 - December 2003
Gilead Sciences May 2002 - July 2002
Skills
Validation, GMP, Cleaning Validation, SOP, Calibration, Process Validation, FDA, V&V, Sop, Quality Control, Quality Assurance, Pharmaceutical Industry, Change Control, Aseptic Processing, Medical Devices, HPLC, Biotechnology, GxP, 21 CFR Part 11, GLP, CAPA, Quality System, Biopharmaceuticals, Manufacturing
Education
University of Colorado Boulder 1988 — 1992
BA, Economics
Colorado School of Mines 1987 — 1987
ProPharma Group March 2015 - Present
Self Employed October 2014 - March 2015
Bio-Rad Laboratories March 2011 - September 2014
Self-Employed July 2010 - March 2011
Foster Wheeler Biokinetics March 2010 - June 2010
Invensys Validation Technologies December 2006 - February 2010
2006Barry Wehmiller Design Group April 2006 - December 2006
AVI BioPharma January 2004 - April 2006
AVI BioPharma July 2002 - December 2003
Gilead Sciences May 2002 - July 2002
Skills
Validation, GMP, Cleaning Validation, SOP, Calibration, Process Validation, FDA, V&V, Sop, Quality Control, Quality Assurance, Pharmaceutical Industry, Change Control, Aseptic Processing, Medical Devices, HPLC, Biotechnology, GxP, 21 CFR Part 11, GLP, CAPA, Quality System, Biopharmaceuticals, Manufacturing
Education
University of Colorado Boulder 1988 — 1992
BA, Economics
Colorado School of Mines 1987 — 1987
Janic Grondin Janic Grondin's Invensys Validation Technologies Experience December 2001 - January 2007
Job Program Manager at Schneider Electric
Industry Industrial Automation
Experience
Consultant April 2014 - Present
Consultante March 2013 - Present
Consultant January 2011 - June 2013
Invensys January 2007 - January 2011
Invensys Validation Technologies December 2001 - January 2007
Johnson Diagnosys September 1999 - December 2001
Abitibi Consolidated June 1995 - September 1999
Skills
Automation, Endorsements, Process Automation, Process Control, GMP, PLC, Commissioning, Process Engineering, SCADA, Instrumentation, DCS, Engineering, Engineering Management, Validation, Control Systems Design, Project Management, Management
Education
UQAM/Alternatives/Laboratoire d'AU 2013 — 2013
Certification EcoLeader, Agriculture Urbaine
PMI 2005 — 2005
PMP, PMP
Université de Sherbrooke 2000 — 2005
Master, Project Engineering
Université Laval 1991 — 1995
Bachelor of Applied Science (B.A.Sc.), Chemical Engineering
Université de Moncton 1990 — 1991
General Engineering
Consultant April 2014 - Present
Consultante March 2013 - Present
Consultant January 2011 - June 2013
Invensys January 2007 - January 2011
Invensys Validation Technologies December 2001 - January 2007
Johnson Diagnosys September 1999 - December 2001
Abitibi Consolidated June 1995 - September 1999
Skills
Automation, Endorsements, Process Automation, Process Control, GMP, PLC, Commissioning, Process Engineering, SCADA, Instrumentation, DCS, Engineering, Engineering Management, Validation, Control Systems Design, Project Management, Management
Education
UQAM/Alternatives/Laboratoire d'AU 2013 — 2013
Certification EcoLeader, Agriculture Urbaine
PMI 2005 — 2005
PMP, PMP
Université de Sherbrooke 2000 — 2005
Master, Project Engineering
Université Laval 1991 — 1995
Bachelor of Applied Science (B.A.Sc.), Chemical Engineering
Université de Moncton 1990 — 1991
General Engineering
Stephane Michaud Stephane Michaud's Invensys Validation Technologies Experience May 2006 - May 2008
Job Flight Instructor, Class 3 at Cargair Flight Academy
Industry Aviation & Aerospace
Experience
Cargair Flight Academy July 2013 - Present
Cargair Flight Academy August 2012 - July 2013
Cargair Flight Academy 2010 - 2011
Petro Air Service January 2009 - June 2009
Invensys Validation Technologies May 2006 - May 2008
Kelly Services 2004 - 2006
HEC Montreal 1998 - 2002
Skills
Aerospace, Aircraft, Aviation, Commercial Aviation, Flight Planning, Flights, Piloting, Flight Training, Flight Safety, Multi-engine, Aeronautics, Civil Aviation, Airports, Management, Aircraft Maintenance
Education
Cargair Flight Academy 2011 — 2012
Instructor Qualification
Cargair Flight Academy 2007 — 2011
Commercial Pilot Licence, Flying
HEC Montréal 1998 — 2002
Collège Bois-de-Boulogne 1995 — 1998
Human Sciences
École secondaie Saint-Sacrement
Cargair Flight Academy July 2013 - Present
Cargair Flight Academy August 2012 - July 2013
Cargair Flight Academy 2010 - 2011
Petro Air Service January 2009 - June 2009
Invensys Validation Technologies May 2006 - May 2008
Kelly Services 2004 - 2006
HEC Montreal 1998 - 2002
Skills
Aerospace, Aircraft, Aviation, Commercial Aviation, Flight Planning, Flights, Piloting, Flight Training, Flight Safety, Multi-engine, Aeronautics, Civil Aviation, Airports, Management, Aircraft Maintenance
Education
Cargair Flight Academy 2011 — 2012
Instructor Qualification
Cargair Flight Academy 2007 — 2011
Commercial Pilot Licence, Flying
HEC Montréal 1998 — 2002
Collège Bois-de-Boulogne 1995 — 1998
Human Sciences
École secondaie Saint-Sacrement
Robert Stotz Robert Stotz's Invensys Validation Technologies Experience October 1997 - July 2000
Job Owner, Validation Compliance Inc.
Industry Pharmaceuticals
Experience
Validation Compliance Inc. July 2004 - Present
Lachman Consultant Services July 2012 - April 2013
Tunnell Consulting August 2009 - January 2010
Validation Technologies, Inc. July 2000 - July 2004
Invensys Validation Technologies October 1997 - July 2000
Jacobs Engineering January 1991 - October 1997
The Upjohn Company (now Pfizer) June 1979 - November 1990
Skills
FDA, Analytical Skills, Validation, Sop, Oncology, GMP, 21 CFR Part 11, Information Technology, Pharmaceutical Industry, Change Control, Technology Transfer, Computer System..., V&V, Quality Control, Pharmaceutics, Biopharmaceuticals, Quality Assurance, CAPA, Quality System, Quality Management, Clinical Development, GLP, GxP, Quality Auditing, Regulatory Affairs, Manufacturing, Regulatory Submissions, Cross-functional Team..., ISO, Biotechnology, Medical Devices, Six Sigma, GAMP, Operational Excellence, Lifesciences, Document Management, LIMS, Cleaning Validation, Vaccines, Formulation, Drug Development, Process Engineering, Aseptic Processing, Management, Process Simulation, Software Documentation, Laboratory, Automation, Regulatory Requirements, Clinical Trials
Education
University of Florida 1966 — 1970
Ph. D., Chemistry
Ida High School 1955 — 1960
University of Toledo
M.S., Chemistry
University of Toledo
B.S., Chemistry
Validation Compliance Inc. July 2004 - Present
Lachman Consultant Services July 2012 - April 2013
Tunnell Consulting August 2009 - January 2010
Validation Technologies, Inc. July 2000 - July 2004
Invensys Validation Technologies October 1997 - July 2000
Jacobs Engineering January 1991 - October 1997
The Upjohn Company (now Pfizer) June 1979 - November 1990
Skills
FDA, Analytical Skills, Validation, Sop, Oncology, GMP, 21 CFR Part 11, Information Technology, Pharmaceutical Industry, Change Control, Technology Transfer, Computer System..., V&V, Quality Control, Pharmaceutics, Biopharmaceuticals, Quality Assurance, CAPA, Quality System, Quality Management, Clinical Development, GLP, GxP, Quality Auditing, Regulatory Affairs, Manufacturing, Regulatory Submissions, Cross-functional Team..., ISO, Biotechnology, Medical Devices, Six Sigma, GAMP, Operational Excellence, Lifesciences, Document Management, LIMS, Cleaning Validation, Vaccines, Formulation, Drug Development, Process Engineering, Aseptic Processing, Management, Process Simulation, Software Documentation, Laboratory, Automation, Regulatory Requirements, Clinical Trials
Education
University of Florida 1966 — 1970
Ph. D., Chemistry
Ida High School 1955 — 1960
University of Toledo
M.S., Chemistry
University of Toledo
B.S., Chemistry
Don Waye Don Waye's Invensys Validation Technologies Experience 2005 - 2007
Job Team Lead Validation of the SCADA system of the Integrated Command and Control System Montreal Métro
Industry Computer Software
Experience
Alstom Transport August 2007 - Present
Averna August 2007 - June 2009
Invensys Validation Technologies 2005 - 2007
Hemosol 2000 - 2003
SNC Lavalin Pharma 1992 - 2002
AHT 1984 - 1992
Asea Brown Boveri (Pvt.) Ltd. 1980 - 1982
Skills
SCADA, Automation, Commissioning, Process Control, PLC, Manufacturing, Instrumentation, Engineering, Validation, Process Engineering, Systems Engineering, Testing, MS Project, Project Management, Electronics, Troubleshooting, Integration, Project Engineering, R&D, Software Development, Software Design, Engineering Management, C++, DCS, UML, Software Engineering, Embedded Systems, Programming, Electrical Engineering, Continuous Improvement, ClearCase, ClearQuest, Control Systems Design, Embedded Software, Engineering Design, Labview, MES, Modbus, Process Automation, Process Simulation, Procurement, Quality Assurance, Quality Management, Simulations, Sop, System Design, System Testing, TWS, Test Automation, Visual Studio
Education
The University of Manchester 1969 — 1972
MSc, automation - pulp & paper
McGill University 1963 — 1967
B. ScA., Physics & Math
Alstom Transport August 2007 - Present
Averna August 2007 - June 2009
Invensys Validation Technologies 2005 - 2007
Hemosol 2000 - 2003
SNC Lavalin Pharma 1992 - 2002
AHT 1984 - 1992
Asea Brown Boveri (Pvt.) Ltd. 1980 - 1982
Skills
SCADA, Automation, Commissioning, Process Control, PLC, Manufacturing, Instrumentation, Engineering, Validation, Process Engineering, Systems Engineering, Testing, MS Project, Project Management, Electronics, Troubleshooting, Integration, Project Engineering, R&D, Software Development, Software Design, Engineering Management, C++, DCS, UML, Software Engineering, Embedded Systems, Programming, Electrical Engineering, Continuous Improvement, ClearCase, ClearQuest, Control Systems Design, Embedded Software, Engineering Design, Labview, MES, Modbus, Process Automation, Process Simulation, Procurement, Quality Assurance, Quality Management, Simulations, Sop, System Design, System Testing, TWS, Test Automation, Visual Studio
Education
The University of Manchester 1969 — 1972
MSc, automation - pulp & paper
McGill University 1963 — 1967
B. ScA., Physics & Math
James Lysaght's Invensys Validation Technologies Experience April 2006 - April 2007
Job Professional Services Sales Manager North America at GE Intelligent Platforms
Industry Pharmaceuticals
Experience
GE Intelligent Platforms August 2015 - Present
Eagles Nest School - A private homeschool August 2009 - Present
Schneider Electric January 2014 - July 2015
Invensys April 2010 - December 2013
Invensys Operations Management April 2009 - April 2010
Invensys Process Systems April 2008 - April 2009
Invensys Process Systems April 2007 - April 2008
Invensys Validation Technologies April 2006 - April 2007
Invensys Validation Technologies August 2005 - April 2006
CimQuest December 2002 - August 2005
Skills
Wonderware, Information Technology, Triconex, Computer System..., Avantis, Validation, GAMP, 21 CFR Part 11, Change Control, GMP, FDA, MES, Instrumentation, Process Control, Automation, Sales, Business Development, Customer Satisfaction, Customer Oriented, History, Cultural Studies, Manufacturing, CRM, PLC, Integration, DCS, Software Documentation, SCADA, Enterprise Software, Business Process..., Strategy, Medical Devices, Modbus, Profibus, Project Management, HMIs, Commissioning, Competitive Analysis, Industrial Control, Process Engineering, Allen Bradley, Management, Leadership, Process Optimization, Sales Process, Control Logic, Cross-functional Team..., Process Automation, Control Systems Design, Salesforce.com
Education
Clemson University 1987 — 1992
BS, Electrical Engineering
GE Intelligent Platforms August 2015 - Present
Eagles Nest School - A private homeschool August 2009 - Present
Schneider Electric January 2014 - July 2015
Invensys April 2010 - December 2013
Invensys Operations Management April 2009 - April 2010
Invensys Process Systems April 2008 - April 2009
Invensys Process Systems April 2007 - April 2008
Invensys Validation Technologies April 2006 - April 2007
Invensys Validation Technologies August 2005 - April 2006
CimQuest December 2002 - August 2005
Skills
Wonderware, Information Technology, Triconex, Computer System..., Avantis, Validation, GAMP, 21 CFR Part 11, Change Control, GMP, FDA, MES, Instrumentation, Process Control, Automation, Sales, Business Development, Customer Satisfaction, Customer Oriented, History, Cultural Studies, Manufacturing, CRM, PLC, Integration, DCS, Software Documentation, SCADA, Enterprise Software, Business Process..., Strategy, Medical Devices, Modbus, Profibus, Project Management, HMIs, Commissioning, Competitive Analysis, Industrial Control, Process Engineering, Allen Bradley, Management, Leadership, Process Optimization, Sales Process, Control Logic, Cross-functional Team..., Process Automation, Control Systems Design, Salesforce.com
Education
Clemson University 1987 — 1992
BS, Electrical Engineering
Marc Vermette's Invensys Validation Technologies Experience June 2004 - January 2005
Job Sr. Director, Global Programs at Schneider Electric
Industry Information Technology and Services
Experience
Schneider Electric January 2015 - Present
Schneider Electric January 2014 - Present
Invensys April 2012 - Present
Invensys September 2013 - February 2015
Invensys Operations Management February 2010 - July 2012
Invensys Operations Management June 2009 - December 2010
Invensys - Wonderware April 2007 - June 2009
Invensys - Wonderware January 2005 - April 2007
Invensys Validation Technologies June 2004 - January 2005
Walsh Automation/Invensys 1998 - 2004
Skills
Program Management, Strategy, MES, Enterprise Software, Management, Business Development, Project Management, Automation, Process Automation, SCADA, Integration, Process Control, Solution Selling, PMO, Software Project..., Process Engineering, Leadership, Account Management, Professional Services, Manufacturing, Industrial Engineering, Consulting, ERP, Product Management, Cross-functional Team..., Certified Project..., Food & Beverage, CPG Industry, FMCG, Business Process, New Business Development, Business Model...
Education
Université de Montréal - Ecole polytechnique de Montréal 1993 — 1997
Bachelor, Mechanical Engineering - Manufacturing
Collège de Maisonneuve 1991 — 1993
College, Sciences
Collège Jean-Eudes 1986 — 1991
Secondaire, General
Schneider Electric January 2015 - Present
Schneider Electric January 2014 - Present
Invensys April 2012 - Present
Invensys September 2013 - February 2015
Invensys Operations Management February 2010 - July 2012
Invensys Operations Management June 2009 - December 2010
Invensys - Wonderware April 2007 - June 2009
Invensys - Wonderware January 2005 - April 2007
Invensys Validation Technologies June 2004 - January 2005
Walsh Automation/Invensys 1998 - 2004
Skills
Program Management, Strategy, MES, Enterprise Software, Management, Business Development, Project Management, Automation, Process Automation, SCADA, Integration, Process Control, Solution Selling, PMO, Software Project..., Process Engineering, Leadership, Account Management, Professional Services, Manufacturing, Industrial Engineering, Consulting, ERP, Product Management, Cross-functional Team..., Certified Project..., Food & Beverage, CPG Industry, FMCG, Business Process, New Business Development, Business Model...
Education
Université de Montréal - Ecole polytechnique de Montréal 1993 — 1997
Bachelor, Mechanical Engineering - Manufacturing
Collège de Maisonneuve 1991 — 1993
College, Sciences
Collège Jean-Eudes 1986 — 1991
Secondaire, General
Alicia Espinoza, B.Sc., PMP Alicia Espinoza, B.Sc., PMP's Invensys Validation Technologies Experience 1999 - 2007
Job Consulting Manager, Compliance Consulting at Schneider Electric
Industry Pharmaceuticals
Experience
Schneider Electric 2014 - Present
Invensys 2007 - June 2014
Invensys Validation Technologies 1999 - 2007
Skills
Quality Assurance, 21 CFR Part 11, GMP, Process Automation, MS Project, MES, Change Control, Commissioning, SCADA, Computer System..., Validation, Pharmaceutical Industry, GAMP, Automation, Software Documentation, Continuous Improvement, Project Management, Process Control, Instrumentation, FDA, V&V, CAPA, Quality Management, GxP, Process Engineering, Six Sigma, PLC, DCS, Quality System
Education
Concordia University 1994 — 1998
Schneider Electric 2014 - Present
Invensys 2007 - June 2014
Invensys Validation Technologies 1999 - 2007
Skills
Quality Assurance, 21 CFR Part 11, GMP, Process Automation, MS Project, MES, Change Control, Commissioning, SCADA, Computer System..., Validation, Pharmaceutical Industry, GAMP, Automation, Software Documentation, Continuous Improvement, Project Management, Process Control, Instrumentation, FDA, V&V, CAPA, Quality Management, GxP, Process Engineering, Six Sigma, PLC, DCS, Quality System
Education
Concordia University 1994 — 1998
Mitch Hendrickson's Invensys Validation Technologies Experience June 2003 - March 2004
Job Associate Consultant Market Research / Forecasting at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company April 2014 - Present
Eli Lilly and Company February 2012 - April 2014
Eli Lilly and Company February 2010 - February 2012
Eli Lilly and Company April 2008 - February 2010
Eli Lilly April 2004 - April 2008
Invensys Validation Technologies June 2003 - March 2004
Pacific Gas and Electric Company January 2003 - March 2003
Pacific Gas and Electric Company June 2002 - August 2002
Rio Tinto Alcan May 2001 - August 2001
Rio Tinto Alcan May 2000 - August 2000
Skills
Cross-functional Team..., Validation, Manufacturing, Forecasting, Leadership, Quality System, Supply Chain, GMP, Biotechnology, Financial Analysis, Procurement, Analysis, Process Improvement, Pharmaceutical Industry, Management, Testing, Computer System..., Data Analysis, Project Management, Six Sigma, Financial Modeling, Market Research, FDA, Logistics, Root Cause Analysis, Change Control, Medical Devices
Education
Indiana University - Kelley School of Business 2008 — 2011
MBA, Business - Finance
Rose-Hulman Institute of Technology 2000 — 2003
BS, Electrical Engineering
Indiana University Bloomington 1999 — 2000
BS
Eli Lilly and Company April 2014 - Present
Eli Lilly and Company February 2012 - April 2014
Eli Lilly and Company February 2010 - February 2012
Eli Lilly and Company April 2008 - February 2010
Eli Lilly April 2004 - April 2008
Invensys Validation Technologies June 2003 - March 2004
Pacific Gas and Electric Company January 2003 - March 2003
Pacific Gas and Electric Company June 2002 - August 2002
Rio Tinto Alcan May 2001 - August 2001
Rio Tinto Alcan May 2000 - August 2000
Skills
Cross-functional Team..., Validation, Manufacturing, Forecasting, Leadership, Quality System, Supply Chain, GMP, Biotechnology, Financial Analysis, Procurement, Analysis, Process Improvement, Pharmaceutical Industry, Management, Testing, Computer System..., Data Analysis, Project Management, Six Sigma, Financial Modeling, Market Research, FDA, Logistics, Root Cause Analysis, Change Control, Medical Devices
Education
Indiana University - Kelley School of Business 2008 — 2011
MBA, Business - Finance
Rose-Hulman Institute of Technology 2000 — 2003
BS, Electrical Engineering
Indiana University Bloomington 1999 — 2000
BS
Chandra Krishnamaneni Chandra Krishnamaneni's Invensys Validation Technologies Experience 2003 - 2008
Job Sr. Director of Quality Assurance & PMO at Wolters Kluwer
Industry Information Technology and Services
Experience
Wolters Kluwer Clinical Drug Information January 2014 - Present
T2 Systems January 2008 - January 2014
Invensys 2003 - 2008
Invensys Validation Technologies 2003 - 2008
Invensys Process Systems 2003 - 2008
Eli Lilly and Company 2003 - 2007
Eli Lilly November 2001 - July 2003
Skills
GAMP, Automation, 21 CFR Part 11, Computer System..., Validation, Quality Assurance, Change Control, FDA, GMP, Software Development, V&V, Testing, Software Documentation, GxP, Software Quality..., Cross-functional Team..., Program Management, Software Project..., PMP, Quality Management, SDLC, Requirements Analysis, Agile Methodologies, Integration, Process Improvement, Test Management, Agile Project Management, Process Simulation, Requirements Gathering, System Testing, MS Project, Test Planning, User Acceptance Testing, Visio, Scrum, IT Project & Program..., Product Development
Education
Doctor Babasaheb Ambedkar Marathwada University 1989 — 1993
BS, Engineering
Wolters Kluwer Clinical Drug Information January 2014 - Present
T2 Systems January 2008 - January 2014
Invensys 2003 - 2008
Invensys Validation Technologies 2003 - 2008
Invensys Process Systems 2003 - 2008
Eli Lilly and Company 2003 - 2007
Eli Lilly November 2001 - July 2003
Skills
GAMP, Automation, 21 CFR Part 11, Computer System..., Validation, Quality Assurance, Change Control, FDA, GMP, Software Development, V&V, Testing, Software Documentation, GxP, Software Quality..., Cross-functional Team..., Program Management, Software Project..., PMP, Quality Management, SDLC, Requirements Analysis, Agile Methodologies, Integration, Process Improvement, Test Management, Agile Project Management, Process Simulation, Requirements Gathering, System Testing, MS Project, Test Planning, User Acceptance Testing, Visio, Scrum, IT Project & Program..., Product Development
Education
Doctor Babasaheb Ambedkar Marathwada University 1989 — 1993
BS, Engineering
Louis Veronneau's Invensys Validation Technologies Experience 2004 - 2007
Job Client Sales Executive at Schneider Electric
Industry Oil & Energy
Experience
Schneider Electric September 2014 - Present
SNC-Lavalin February 2014 - September 2014
Keops Technologies Inc August 2010 - January 2014
Invensys Process Systems 2007 - August 2010
DSM and GSK Bio 2000 - 2009
Invensys Validation Technologies 2004 - 2007
Invensys Validation Technologies 2000 - 2004
Wyeth Montreal 1998 - 2004
Valadation Technologies Inc 1998 - 2000
Diversy Lever 1995 - 1998
Skills
Project Management, MES, SCADA, Automation, Process Automation, Marketing, Manufacturing, Process Control, Integration, 21 CFR Part 11, Validation, Business Development, MS Project, ERP, Computer System...
Education
Université de Sherbrooke 1990 — 1995
Bs., Chemical Engieering
Schneider Electric September 2014 - Present
SNC-Lavalin February 2014 - September 2014
Keops Technologies Inc August 2010 - January 2014
Invensys Process Systems 2007 - August 2010
DSM and GSK Bio 2000 - 2009
Invensys Validation Technologies 2004 - 2007
Invensys Validation Technologies 2000 - 2004
Wyeth Montreal 1998 - 2004
Valadation Technologies Inc 1998 - 2000
Diversy Lever 1995 - 1998
Skills
Project Management, MES, SCADA, Automation, Process Automation, Marketing, Manufacturing, Process Control, Integration, 21 CFR Part 11, Validation, Business Development, MS Project, ERP, Computer System...
Education
Université de Sherbrooke 1990 — 1995
Bs., Chemical Engieering
Jean-Maxime Guay Jean-Maxime Guay's Invensys Validation Technologies Experience May 2008 - August 2008
Job PAT Scientist at Pfizer
Industry Consumer Goods
Experience
Pfizer May 2012 - Present
Pfizer January 2010 - April 2012
Johnson & Johnson January 2009 - April 2009
Invensys Validation Technologies May 2008 - August 2008
Merck Frosst September 2007 - December 2007
Centre de génomique fonctionnelle de l'UdeS January 2007 - April 2007
Skills
Technology Transfer, GMP, CAPA, Quality Assurance, Biotechnology, Manufacturing, Pharmaceutical Industry, Project Management, Spectroscopy, Quality by Design
Education
Université de Sherbrooke 2010 — 2012
Maîtrise en milieu industrielle, Génie chimique
Université de Sherbrooke 2005 — 2009
Baccalauréat, Génie biotechnologique
Université de Montréal 2002 — 2005
Baccalauréat, Bioinformatique
College Jean-de-Brebeuf 2000 — 2002
D.E.C., Sciences de la santé
College St-Sacrement 1995 — 2000
D.E.S.
Pfizer May 2012 - Present
Pfizer January 2010 - April 2012
Johnson & Johnson January 2009 - April 2009
Invensys Validation Technologies May 2008 - August 2008
Merck Frosst September 2007 - December 2007
Centre de génomique fonctionnelle de l'UdeS January 2007 - April 2007
Skills
Technology Transfer, GMP, CAPA, Quality Assurance, Biotechnology, Manufacturing, Pharmaceutical Industry, Project Management, Spectroscopy, Quality by Design
Education
Université de Sherbrooke 2010 — 2012
Maîtrise en milieu industrielle, Génie chimique
Université de Sherbrooke 2005 — 2009
Baccalauréat, Génie biotechnologique
Université de Montréal 2002 — 2005
Baccalauréat, Bioinformatique
College Jean-de-Brebeuf 2000 — 2002
D.E.C., Sciences de la santé
College St-Sacrement 1995 — 2000
D.E.S.
Nelson Tavares Nelson Tavares's Invensys Validation Technologies Experience February 2006 - January 2011
Job Project Management at Laporte Consultants
Industry Pharmaceuticals
Experience
Laporte Consultants January 2011 - Present
Invensys Validation Technologies February 2006 - January 2011
DSM Biologics 2001 - 2005
Skills
GMP, Validation, FDA, Pharmaceutical Industry, Sop, 21 CFR Part 11, Biotechnology, Change Control, Quality System, GxP, CAPA, GAMP, Quality Assurance, Biopharmaceuticals, BPF, Project Management, SOP
Education
Université du Québec à Montréal 1998 — 2001
B.SC, Biology
Laporte Consultants January 2011 - Present
Invensys Validation Technologies February 2006 - January 2011
DSM Biologics 2001 - 2005
Skills
GMP, Validation, FDA, Pharmaceutical Industry, Sop, 21 CFR Part 11, Biotechnology, Change Control, Quality System, GxP, CAPA, GAMP, Quality Assurance, Biopharmaceuticals, BPF, Project Management, SOP
Education
Université du Québec à Montréal 1998 — 2001
B.SC, Biology
Jean-Francois Hamelin's Invensys Validation Technologies Experience 2004 - 2006
Job Senior Control Engineer at Valmet Automation
Industry Paper & Forest Products
Experience
Metso Automation Ingénieur de contrôle Sénior / Senior Control EngineerValmet Automation LtéeApril 2015 - Present
Metso Automation 2006 - Present
Invensys Validation Technologies 2004 - 2006
Walsh Automation 2000 - 2005
Education
Université de Montréal - Ecole polytechnique de Montréal 1993 — 2000
Master’s Degree, Chemical Engineering
Metso Automation Ingénieur de contrôle Sénior / Senior Control EngineerValmet Automation LtéeApril 2015 - Present
Metso Automation 2006 - Present
Invensys Validation Technologies 2004 - 2006
Walsh Automation 2000 - 2005
Education
Université de Montréal - Ecole polytechnique de Montréal 1993 — 2000
Master’s Degree, Chemical Engineering
Jane Cotham's Invensys Validation Technologies Experience January 2007 - Present
Job Nuclear Document Control Coordinator at Invensys
Industry Biotechnology
Experience
Invensys March 2009 - Present
Invensys Validation Technologies January 2007 - Present
Invensys 2007 - Present
Rhode Island Blood Center July 1990 - June 2006
Education
Rhode Island College 1987 — 1990
Invensys March 2009 - Present
Invensys Validation Technologies January 2007 - Present
Invensys 2007 - Present
Rhode Island Blood Center July 1990 - June 2006
Education
Rhode Island College 1987 — 1990
Barry Boyle's Invensys Validation Technologies Experience 2000 - 2002
Job Owner, Skillpad Ltd
Industry Biotechnology
Experience
Skillpad Ltd (formarly CompuPharma Ltd) January 2003 - Present
Skillpad (formally, CompuPharma) 2003 - Present
Skillpad 2003 - Present
CompuPharma Ltd 2004 - 2008
INVENSYS PROCESS SYSTEMS 2000 - 2003
Invensys 2000 - 2003
Invensys Validation Technologies 2000 - 2002
Walsh Automation Inc November 1987 - August 2000
Walsh / Invensys 1987 - 2000
Skills
Validation, Project Management, Automation, Process Automation, PLC, Product Development, Manufacturing, SCADA, Commissioning, Integration, Instrumentation, Engineering, Process Control, Testing, Management, GMP, MS Project, Engineering Management
Education
The University of Glasgow 1961 — 1965
BSc, Electrical Engineering
University of Strathclyde 1961 — 1965
BSc, Electricl Engineering
Skillpad Ltd (formarly CompuPharma Ltd) January 2003 - Present
Skillpad (formally, CompuPharma) 2003 - Present
Skillpad 2003 - Present
CompuPharma Ltd 2004 - 2008
INVENSYS PROCESS SYSTEMS 2000 - 2003
Invensys 2000 - 2003
Invensys Validation Technologies 2000 - 2002
Walsh Automation Inc November 1987 - August 2000
Walsh / Invensys 1987 - 2000
Skills
Validation, Project Management, Automation, Process Automation, PLC, Product Development, Manufacturing, SCADA, Commissioning, Integration, Instrumentation, Engineering, Process Control, Testing, Management, GMP, MS Project, Engineering Management
Education
The University of Glasgow 1961 — 1965
BSc, Electrical Engineering
University of Strathclyde 1961 — 1965
BSc, Electricl Engineering
Jon Edgar's Invensys Validation Technologies Experience 2007 - November 2010
Job Project Manager at Particle Measuring Systems
Industry Pharmaceuticals
Experience
Particle Measuring Systems November 2010 - Present
Invensys Validation Technologies 2007 - November 2010
Invensys March 2006 - November 2010
SEC Associates, Inc. 2006 - 2007
Advanced Barrier Concepts 2002 - 2006
BioReliance 2001 - 2002
Skills
GAMP, 21 CFR Part 11, Validation, Computer System..., FDA, Change Control, V&V, Medical Devices, Quality Assurance, Sop, GMP, CAPA, Software Documentation, Quality System, GxP, Biotechnology, Quality Control, LIMS, SOP, Pharmaceutical Industry
Education
University of Colorado at Colorado Springs 1993 — 1995
Bachelor's degree, Biology
Particle Measuring Systems November 2010 - Present
Invensys Validation Technologies 2007 - November 2010
Invensys March 2006 - November 2010
SEC Associates, Inc. 2006 - 2007
Advanced Barrier Concepts 2002 - 2006
BioReliance 2001 - 2002
Skills
GAMP, 21 CFR Part 11, Validation, Computer System..., FDA, Change Control, V&V, Medical Devices, Quality Assurance, Sop, GMP, CAPA, Software Documentation, Quality System, GxP, Biotechnology, Quality Control, LIMS, SOP, Pharmaceutical Industry
Education
University of Colorado at Colorado Springs 1993 — 1995
Bachelor's degree, Biology
Tania Simoncelli, Eng., PMP's Invensys Validation Technologies Experience 1998 - Present
Job Managing Consultant at INVENSYS
Industry Pharmaceuticals
Experience
INVENSYS May 2008 - Present
Invensys Validation Technologies 1998 - Present
Education
McGill University 1995 — 1998
B.Eng, Chemical Engineer
INVENSYS May 2008 - Present
Invensys Validation Technologies 1998 - Present
Education
McGill University 1995 — 1998
B.Eng, Chemical Engineer
Bryant Chan's Invensys Validation Technologies Experience January 2007 - May 2009
Job Validation Manager at Gilead Sciences
Industry Biotechnology
Experience
Gilead Sciences May 2014 - Present
Prolacta Bioscience October 2011 - April 2014
Aaron Industries Inc December 2010 - October 2011
Aaron Industries Inc. August 2009 - December 2010
Invensys Validation Technologies January 2007 - May 2009
Amgen (Client) 2007 - 2009
Grifols Biologicals Inc June 2001 - December 2006
Alpha Therapeutic, Inc. 2001 - 2006
Insituto Grifols/ Grifols Biologicals 1998 - 2006
Alpha Therapeutics Corporation (Now Grifols Biologicals) 1998 - 2003
Skills
CAPA, Aseptic Processing, V&V, 21 CFR Part 11, Validation, FDA, Change Control, GMP, Cleaning Validation, Computer System..., Sop, GAMP, Quality System, Pharmaceutical Industry, Quality Assurance, GxP, Technology Transfer, GLP, Biopharmaceuticals, Biotechnology, ISO 13485, Quality Auditing, Sterilization, Process Simulation, LIMS, Quality Control, SOP, Six Sigma, 21 CFR, Aseptic Technique
Education
California State University-Los Angeles 1987 — 1993
Gilead Sciences May 2014 - Present
Prolacta Bioscience October 2011 - April 2014
Aaron Industries Inc December 2010 - October 2011
Aaron Industries Inc. August 2009 - December 2010
Invensys Validation Technologies January 2007 - May 2009
Amgen (Client) 2007 - 2009
Grifols Biologicals Inc June 2001 - December 2006
Alpha Therapeutic, Inc. 2001 - 2006
Insituto Grifols/ Grifols Biologicals 1998 - 2006
Alpha Therapeutics Corporation (Now Grifols Biologicals) 1998 - 2003
Skills
CAPA, Aseptic Processing, V&V, 21 CFR Part 11, Validation, FDA, Change Control, GMP, Cleaning Validation, Computer System..., Sop, GAMP, Quality System, Pharmaceutical Industry, Quality Assurance, GxP, Technology Transfer, GLP, Biopharmaceuticals, Biotechnology, ISO 13485, Quality Auditing, Sterilization, Process Simulation, LIMS, Quality Control, SOP, Six Sigma, 21 CFR, Aseptic Technique
Education
California State University-Los Angeles 1987 — 1993
Marlène Tchipandi's Invensys Validation Technologies Experience February 2006 - October 2007
Job Process Development Specialist at Jubilant HollisterStier Contract Manufacturing & Services
Industry Pharmaceuticals
Experience
Jubilant HollisterStier Contract Manufacturing & Services June 2015 - Present
Winpak July 2013 - Present
Jubilant HollisterStier LLC October 2008 - July 2013
ROPACK October 2007 - September 2008
Invensys Validation Technologies February 2006 - October 2007
Skills
Technology Transfer, Process Validation, SOP, Process Improvement, GMP
Education
Université de Montréal - Ecole polytechnique de Montréal 1999 — 2003
Bachelor's degree, Chemical Engineering
Jubilant HollisterStier Contract Manufacturing & Services June 2015 - Present
Winpak July 2013 - Present
Jubilant HollisterStier LLC October 2008 - July 2013
ROPACK October 2007 - September 2008
Invensys Validation Technologies February 2006 - October 2007
Skills
Technology Transfer, Process Validation, SOP, Process Improvement, GMP
Education
Université de Montréal - Ecole polytechnique de Montréal 1999 — 2003
Bachelor's degree, Chemical Engineering
Michael Navarro, PMP's Invensys Validation Technologies Experience September 2007 - August 2008
Job Project Manager at Cook Pharmica
Industry Pharmaceuticals
Experience
Cook Pharmica October 2013 - Present
Cook Pharmica April 2011 - January 2014
Cook Pharmica December 2010 - April 2011
BioConvergence LLC August 2008 - December 2010
Invensys Validation Technologies September 2007 - August 2008
Baxter Pharmaceutical Solutions 2003 - 2007
Baxter BioPharma Solutions 2003 - 2007
Skills
GMP, CAPA, Validation, FDA, Cleaning Validation, Software Documentation, 21 CFR Part 11, Change Control, Sop, V&V, Quality System, Technology Transfer, Biopharmaceuticals, Computer System..., Quality Assurance, Pharmaceutical Industry, SOP, GxP, Aseptic Processing, Biotechnology
Education
Indiana University Bloomington 1996 — 2000
Bachelor of Science (BS), Biology, General
Cook Pharmica October 2013 - Present
Cook Pharmica April 2011 - January 2014
Cook Pharmica December 2010 - April 2011
BioConvergence LLC August 2008 - December 2010
Invensys Validation Technologies September 2007 - August 2008
Baxter Pharmaceutical Solutions 2003 - 2007
Baxter BioPharma Solutions 2003 - 2007
Skills
GMP, CAPA, Validation, FDA, Cleaning Validation, Software Documentation, 21 CFR Part 11, Change Control, Sop, V&V, Quality System, Technology Transfer, Biopharmaceuticals, Computer System..., Quality Assurance, Pharmaceutical Industry, SOP, GxP, Aseptic Processing, Biotechnology
Education
Indiana University Bloomington 1996 — 2000
Bachelor of Science (BS), Biology, General
Lisa Niggeman's Invensys Validation Technologies Experience January 2008 - April 2009
Job at
Industry Pharmaceuticals
Experience
Actavis April 2012 - Present
Harmony Labs February 2011 - April 2012
Sanofi Pasteur July 2010 - March 2011
BioConvergence LLC April 2009 - June 2010
Invensys Validation Technologies January 2008 - April 2009
Sanofi Pasteur 2008 - 2009
Baxter October 2003 - January 2008
Roche Diagnostics 2008 - 2008
Baxter BioScience February 2002 - October 2003
Skills
Sop, GMP, Change Control, HPLC, 21 CFR Part 11, Cleaning Validation, Laboratory, Analytical Chemistry, UV/Vis, UV, Quality Control, Technical Writing, CAPA, FDA, Pharmaceutical Industry, Validation
Education
Oakland University
Actavis April 2012 - Present
Harmony Labs February 2011 - April 2012
Sanofi Pasteur July 2010 - March 2011
BioConvergence LLC April 2009 - June 2010
Invensys Validation Technologies January 2008 - April 2009
Sanofi Pasteur 2008 - 2009
Baxter October 2003 - January 2008
Roche Diagnostics 2008 - 2008
Baxter BioScience February 2002 - October 2003
Skills
Sop, GMP, Change Control, HPLC, 21 CFR Part 11, Cleaning Validation, Laboratory, Analytical Chemistry, UV/Vis, UV, Quality Control, Technical Writing, CAPA, FDA, Pharmaceutical Industry, Validation
Education
Oakland University
Jeremy Klein's Invensys Validation Technologies Experience June 2008 - November 2009
Job Senior Validation Engineer
Industry Pharmaceuticals
Experience
QS Pharma April 2015 - Present
CSL Behring September 2013 - November 2013
QS Pharma February 2012 - March 2013
Medical Product Labs July 2011 - November 2011
Accupac February 2010 - June 2010
Day & Zimmermann August 2009 - November 2009
Invensys Validation Technologies June 2008 - November 2009
Invensys Process Technologies June 2008 - May 2009
AVS Consulting 2000 - 2001
AVS Consulting 2000 - 2001
Skills
Validation, GMP, Commissioning, cGMP, Pharmaceuticals, Process Validation, V&V, HVAC, GxP, Microsoft Office, Excel, CAPA, Change Control, Quality Reviews
Education
Penn State University 1995 — 1999
Bachelor of Science (B.S.), Chemical Engineering
QS Pharma April 2015 - Present
CSL Behring September 2013 - November 2013
QS Pharma February 2012 - March 2013
Medical Product Labs July 2011 - November 2011
Accupac February 2010 - June 2010
Day & Zimmermann August 2009 - November 2009
Invensys Validation Technologies June 2008 - November 2009
Invensys Process Technologies June 2008 - May 2009
AVS Consulting 2000 - 2001
AVS Consulting 2000 - 2001
Skills
Validation, GMP, Commissioning, cGMP, Pharmaceuticals, Process Validation, V&V, HVAC, GxP, Microsoft Office, Excel, CAPA, Change Control, Quality Reviews
Education
Penn State University 1995 — 1999
Bachelor of Science (B.S.), Chemical Engineering
Valérie Roussin-Paradis's Invensys Validation Technologies Experience February 1999 - August 2006
Job Director, Global Business Development at Montrium
Industry Pharmaceuticals
Experience
Montrium 2012 - Present
Solabs Inc. January 2008 - May 2011
Pure Vision Pharma 2008 - 2009
Invensys Validation Technologies February 1999 - August 2006
Nakornthai Strip Mill, Thailand June 1997 - June 1999
Skills
Validation, Pharmaceutical Industry, 21 CFR Part 11, Business Analysis, Project Management, SharePoint, Quality Assurance, Cross-functional Team..., Six Sigma, CAPA, GMP, Requirements Analysis, Quality System, FDA, Software Documentation, Consulting
Education
Université de Montréal - Ecole polytechnique de Montréal 1990 — 1995
Bachelor degree in Engineering
Séminaire de Joliette
Montrium 2012 - Present
Solabs Inc. January 2008 - May 2011
Pure Vision Pharma 2008 - 2009
Invensys Validation Technologies February 1999 - August 2006
Nakornthai Strip Mill, Thailand June 1997 - June 1999
Skills
Validation, Pharmaceutical Industry, 21 CFR Part 11, Business Analysis, Project Management, SharePoint, Quality Assurance, Cross-functional Team..., Six Sigma, CAPA, GMP, Requirements Analysis, Quality System, FDA, Software Documentation, Consulting
Education
Université de Montréal - Ecole polytechnique de Montréal 1990 — 1995
Bachelor degree in Engineering
Séminaire de Joliette
Tanya Adderson-Davidson's Invensys Validation Technologies Experience 2007 - 2009
Job Validation Specialist
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions May 2013 - Present
CTG September 2012 - March 2013
Maternity Leave September 2011 - September 2012
Yoh @ Novartis January 2010 - September 2011
Kelly Services June 2009 - January 2010
Invensys Validation Technologies 2007 - 2009
Wyeth Biotech 2003 - 2006
Diosynth 2001 - 2003
Perigon 2000 - 2001
Baxter 1999 - 2000
Skills
CAPA, Computer System..., Validation, Change Control, 21 CFR Part 11, Cleaning Validation, GMP, LIMS, Vaccines, FDA, Regulatory Affairs, Pharmaceutical Industry, Quality Control, Quality System, Technology Transfer, Medical Devices, Sop, GxP, Biotechnology, ISO 13485, Quality Assurance, GAMP, Process Engineering
Education
Tulane University 1996 — 1998
BS, Biomedical Engineering
Xavier University of Louisiana 1993 — 1998
BS, Physics
Catalent Pharma Solutions May 2013 - Present
CTG September 2012 - March 2013
Maternity Leave September 2011 - September 2012
Yoh @ Novartis January 2010 - September 2011
Kelly Services June 2009 - January 2010
Invensys Validation Technologies 2007 - 2009
Wyeth Biotech 2003 - 2006
Diosynth 2001 - 2003
Perigon 2000 - 2001
Baxter 1999 - 2000
Skills
CAPA, Computer System..., Validation, Change Control, 21 CFR Part 11, Cleaning Validation, GMP, LIMS, Vaccines, FDA, Regulatory Affairs, Pharmaceutical Industry, Quality Control, Quality System, Technology Transfer, Medical Devices, Sop, GxP, Biotechnology, ISO 13485, Quality Assurance, GAMP, Process Engineering
Education
Tulane University 1996 — 1998
BS, Biomedical Engineering
Xavier University of Louisiana 1993 — 1998
BS, Physics
Alain Cabana's Invensys Validation Technologies Experience 2002 - 2002
Job Head Industrial Development at Galderma
Industry Pharmaceuticals
Experience
Galderma April 2014 - Present
Bracco/EZEM Canada/Therapex 2009 - April 2014
Ambrilia Biopharma Inc 2003 - November 2009
Invensys Validation Technologies 2002 - 2002
SyePharma Canada 2001 - 2002
Merck Frosst Canada 1996 - 2001
Skills
Drug Development, Biopharmaceuticals, Biotechnology, Clinical Trials, Pharmaceutical Industry, Pharmaceutics, R&D, Technology Transfer, Product Development, Regulatory Submissions, Clinical Development, GMP, Cross-functional Team..., Validation, GLP, Change Control, FDA
Education
Université Laval 1994 — 1996
M. Sc. Pharmaceutical Sciences
Université Laval 1991 — 1994
B. Sc. Chemical Engineering
Galderma April 2014 - Present
Bracco/EZEM Canada/Therapex 2009 - April 2014
Ambrilia Biopharma Inc 2003 - November 2009
Invensys Validation Technologies 2002 - 2002
SyePharma Canada 2001 - 2002
Merck Frosst Canada 1996 - 2001
Skills
Drug Development, Biopharmaceuticals, Biotechnology, Clinical Trials, Pharmaceutical Industry, Pharmaceutics, R&D, Technology Transfer, Product Development, Regulatory Submissions, Clinical Development, GMP, Cross-functional Team..., Validation, GLP, Change Control, FDA
Education
Université Laval 1994 — 1996
M. Sc. Pharmaceutical Sciences
Université Laval 1991 — 1994
B. Sc. Chemical Engineering
Coreen Morin's Invensys Validation Technologies Experience September 1997 - September 2009
Job Validation Engineer at Genzyme
Industry Biotechnology
Experience
Genzyme September 2009 - Present
Invensys Validation Technologies September 1997 - September 2009
Wyeth Biotech 2004 - 2008
Wyeth Biopharma 2004 - 2008
Education
D'Amore-McKim School of Business at Northeastern University 1999 — 2004
Northeastern University 1992 — 1997
BSSEE, Electrical Engineering
Genzyme September 2009 - Present
Invensys Validation Technologies September 1997 - September 2009
Wyeth Biotech 2004 - 2008
Wyeth Biopharma 2004 - 2008
Education
D'Amore-McKim School of Business at Northeastern University 1999 — 2004
Northeastern University 1992 — 1997
BSSEE, Electrical Engineering
Jean-Francois Alie, ing., PMP, LEED Green Associate's Invensys Validation Technologies Experience January 2003 - June 2007
Job Commissioning / Mise en service
Industry Mechanical or Industrial Engineering
Experience
SNC-Lavalin August 2010 - Present
Association Régionale de Rugby de la Rive-Sud May 2012 - May 2015
Association de Rugby Mineur de St-Lambert April 2012 - April 2015
Axcan Pharma December 2008 - July 2010
Invensys Operations Management July 2007 - July 2010
Invensys Validation Technologies January 2003 - June 2007
GSK 2006 - 2007
Innogenetics 2005 - 2005
idCAD May 2001 - January 2003
ACT November 1998 - April 2001
Skills
LEED Green Associate, PMP - 2007, Engineering, Validation, Commissioning
Education
CEGEP Edouard -Montpetit 1991 — 1992
CEGEP, Pure and Applied Science
Université de Sherbrooke 1993 — 1997
Mechanical Engineering - COOP
Jean-de-Brebeuf 1992 — 1993
CEGEP, Pure and Applied Sciences
Séminaire de la Très Sainte Trinité
SNC-Lavalin August 2010 - Present
Association Régionale de Rugby de la Rive-Sud May 2012 - May 2015
Association de Rugby Mineur de St-Lambert April 2012 - April 2015
Axcan Pharma December 2008 - July 2010
Invensys Operations Management July 2007 - July 2010
Invensys Validation Technologies January 2003 - June 2007
GSK 2006 - 2007
Innogenetics 2005 - 2005
idCAD May 2001 - January 2003
ACT November 1998 - April 2001
Skills
LEED Green Associate, PMP - 2007, Engineering, Validation, Commissioning
Education
CEGEP Edouard -Montpetit 1991 — 1992
CEGEP, Pure and Applied Science
Université de Sherbrooke 1993 — 1997
Mechanical Engineering - COOP
Jean-de-Brebeuf 1992 — 1993
CEGEP, Pure and Applied Sciences
Séminaire de la Très Sainte Trinité
Katherine Wallace's Invensys Validation Technologies Experience 2003 - 2004
Job Sr. Director, Process Execution Team Operations at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca May 2014 - Present
AstraZeneca April 2013 - Present
AstraZeneca May 2012 - April 2013
AstraZeneca Pharmaceuticals June 2008 - May 2012
AstraZeneca 2009 - 2010
AstraZeneca 2006 - 2008
AstraZeneca 2004 - 2006
Invensys Validation Technologies 2003 - 2004
Foxboro 1997 - 2003
Invensys/Foxboro 1997 - 2003
Skills
FDA, Validation, Change Control, CAPA, GMP, Quality System, 21 CFR Part 11, Process Simulation, Process Control, Pharmaceutical Industry, Computer System..., Six Sigma, Process Engineering, Automation, Process Automation, Technology Transfer, V&V, Aseptic Processing, Sop, ISO, R&D, GxP, Biopharmaceuticals, GAMP, Formulation, Biotechnology
Education
Tufts University 2001 — 2003
Masters, Engineering Management
University of New Hampshire 1993 — 1997
BS, Chemical Engineering
AstraZeneca May 2014 - Present
AstraZeneca April 2013 - Present
AstraZeneca May 2012 - April 2013
AstraZeneca Pharmaceuticals June 2008 - May 2012
AstraZeneca 2009 - 2010
AstraZeneca 2006 - 2008
AstraZeneca 2004 - 2006
Invensys Validation Technologies 2003 - 2004
Foxboro 1997 - 2003
Invensys/Foxboro 1997 - 2003
Skills
FDA, Validation, Change Control, CAPA, GMP, Quality System, 21 CFR Part 11, Process Simulation, Process Control, Pharmaceutical Industry, Computer System..., Six Sigma, Process Engineering, Automation, Process Automation, Technology Transfer, V&V, Aseptic Processing, Sop, ISO, R&D, GxP, Biopharmaceuticals, GAMP, Formulation, Biotechnology
Education
Tufts University 2001 — 2003
Masters, Engineering Management
University of New Hampshire 1993 — 1997
BS, Chemical Engineering
Simona Camelia Surdila Marin's Invensys Validation Technologies Experience 1997 - 1999
Job Director Quality Assurance at Medtronic
Industry Pharmaceuticals
Experience
Medtronic August 2009 - Present
EZEM CANADA 2007 - 2009
BMS October 2002 - August 2007
Bristol-Myers Squibb 2002 - 2007
SNC lAVALIN 2000 - 2002
Validation Technology 1997 - 1999
Invensys Validation Technologies 1997 - 1999
Education
Université de Montréal - Ecole polytechnique de Montréal
MSc. A Biotechnology, Chemical Engineering
Medtronic August 2009 - Present
EZEM CANADA 2007 - 2009
BMS October 2002 - August 2007
Bristol-Myers Squibb 2002 - 2007
SNC lAVALIN 2000 - 2002
Validation Technology 1997 - 1999
Invensys Validation Technologies 1997 - 1999
Education
Université de Montréal - Ecole polytechnique de Montréal
MSc. A Biotechnology, Chemical Engineering
Gianna De Rubertis's Invensys Validation Technologies Experience July 2003 - July 2008
Job Director of Professional Services at Montrium
Industry Pharmaceuticals
Experience
Montrium April 2015 - Present
Projective July 2008 - Present
Montrium March 2011 - April 2015
Montrium July 2008 - February 2011
Invensys Validation Technologies July 2003 - July 2008
Skills
21 CFR Part 11, Computer System..., GxP, Validation, Sop, LIMS, Change Control, GMP, Quality Assurance, V&V, CAPA, Software Documentation
Education
University of Toronto 2000 — 2002
M.A.Sc.
McGill University 1996 — 2000
B.Eng.
Montrium April 2015 - Present
Projective July 2008 - Present
Montrium March 2011 - April 2015
Montrium July 2008 - February 2011
Invensys Validation Technologies July 2003 - July 2008
Skills
21 CFR Part 11, Computer System..., GxP, Validation, Sop, LIMS, Change Control, GMP, Quality Assurance, V&V, CAPA, Software Documentation
Education
University of Toronto 2000 — 2002
M.A.Sc.
McGill University 1996 — 2000
B.Eng.
Rachel Aubin's Invensys Validation Technologies Experience June 2003 - November 2003
Job Project Manager at Cold Spring Design
Industry Internet
Experience
Cold Spring Design, Inc. April 2012 - Present
Law Offices of James Wingfield March 2011 - May 2011
EMC March 2006 - December 2010
EMC February 2004 - March 2006
Invensys Validation Technologies June 2003 - November 2003
Invensys Systems, Inc. May 2002 - February 2003
Skills
HTML, Dreamweaver, CSS, User Experience, WordPress, Camtasia, Photoshop, Microsoft Office, FrameMaker, Illustrator, Adobe Acrobat, XML, Flash, QuarkXPress, Publishing, JavaScript, Technical Writing, Web Content Management
Education
Emerson College 2000 — 2003
MA, Visual and Media Arts
Syracuse University 1995 — 1998
BS, Television/Radio/Film Production
Cold Spring Design, Inc. April 2012 - Present
Law Offices of James Wingfield March 2011 - May 2011
EMC March 2006 - December 2010
EMC February 2004 - March 2006
Invensys Validation Technologies June 2003 - November 2003
Invensys Systems, Inc. May 2002 - February 2003
Skills
HTML, Dreamweaver, CSS, User Experience, WordPress, Camtasia, Photoshop, Microsoft Office, FrameMaker, Illustrator, Adobe Acrobat, XML, Flash, QuarkXPress, Publishing, JavaScript, Technical Writing, Web Content Management
Education
Emerson College 2000 — 2003
MA, Visual and Media Arts
Syracuse University 1995 — 1998
BS, Television/Radio/Film Production
Bree Arhanic's Invensys Validation Technologies Experience October 2004 - May 2006
Job
Industry
Experience
Invensys Validation Technologies October 2004 - May 2006
Novex Pharma November 2003 - May 2004
Invensys Validation Technologies August 2001 - October 2003
Novartis Pharmaceuticals April 2000 - August 2001
Education
Durham College 1995 — 1999
Food and Drug Technology, Pharmaceutical Sciences
Invensys Validation Technologies October 2004 - May 2006
Novex Pharma November 2003 - May 2004
Invensys Validation Technologies August 2001 - October 2003
Novartis Pharmaceuticals April 2000 - August 2001
Education
Durham College 1995 — 1999
Food and Drug Technology, Pharmaceutical Sciences
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY