PharmEng Technology
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PharmEng Technology Employees
PharmEng Technology September 2011 - Present
Alcon, a Novartis company July 2013 - January 2014
AxSource Consulting Inc. March 2011 - August 2011
Valeant Pharmaceuticals March 2008 - October 2010
SNC-Lavalin April 2005 - August 2007
MDS Pharma Services July 2000 - August 2005
Skills
Quality Assurance, 21 CFR Part 11, Validation, Software Documentation, GMP, GxP, GLP, Computer System..., Testing, Sop, SDLC, Change Control, CAPA, LIMS, FDA, V&V, SOP
Education
Concordia University 1996 — 1999
Bachelor of Commerce (B.Com.), Management Information Systems
Champlain Regional College 1993 — 1995
D.E.C, Commerce
Evonik - North America March 2014 - Present
Stryker Sustainability Solutions June 2013 - March 2014
PharmEng Technology September 2012 - May 2013
GE Healthcare February 2012 - September 2012
Compliance Team, Inc. June 2005 - September 2012
Catalent Pharma Solutions July 2010 - December 2010
KV Pharmaceutical May 2007 - June 2008
Pfizer Pharmaceuticals April 2006 - May 2007
Sigma Aldrich June 2005 - April 2006
Legacy Pharmaceutical Packaging May 2004 - June 2005
Skills
Validation, Process Validation, Medical Devices, Corel Draw, Biotechnology, Commissioning, Access, cGMP, GMP, SOP, Quality Assurance, Compliance, Change Control, FDA, Pharmaceuticals, Continuous Improvement, Aseptic Processing, Process Improvement, Lean Manufacturing, V&V, Sop, Pharmaceutical Industry, Analytical Chemistry, CAPA, 21 CFR Part 11, Computer System..., Manufacturing, Technology Transfer
Education
Southeast Missouri State University 2003 — 2008
BS, Industrial Engineering
St. Louis Community College 1998 — 2002
AAS, Technical Graphics Design
Compliance strategy, set-up, and implementation to pharmaceutical and medical device industry 2015 - Present
Humber College 2011 - Present
Unilever 2013 - 2015
PharmEng Technology 2012 - 2013
Academy of Applied Pharmaceutical Sciences 2012 - 2012
Agfa Healthcare 2011 - 2012
Summit Veterinary Pharmacy Inc. 2010 - 2011
Baxter Healthcare 2006 - 2010
Pax-All Manufacturing Inc. 2004 - 2006
Pax-All Manufacturing Inc. 2003 - 2004
Skills
CAPA, GMP, Quality System, Quality Assurance, Regulatory Affairs, Validation, ISO 13485, Medical Devices, Quality Auditing, Manufacturing, LIMS, Root Cause Analysis, Product Quality, Quality Control, GLP, Training, Technical Writing, SOP, Public Speaking, CFR, Change Control, Regulatory Requirements, Regulatory Submissions, Inspection, Pharmaceutical Industry, 21 CFR Part 11, NHPD, Biotechnology, Six Sigma, V&V, Pharmaceutics, Biopharmaceuticals, Medical Device..., ISO 9001, Compliance Strategy, Post Market Surveillance, USP 795, USP 797, Food and Drugs Act, Food and Drugs..., Annual Product Quality..., Regulatory Strategies, Host Inspections, Technical Course..., Presentations, Establishment Licensing, ICH, Quality Agreement, Stability
Education
University of Santo Tomas 1992 — 1996
B.Sc., Biochemistry
Humber College
Quality Management Program
Seneca College of Applied Arts and Technology
Certificate, Regulatory Affairs and Quality Operations
CBRE May 2013 - Present
CBRE July 2008 - May 2013
PharmEng Technology October 2007 - February 2009
T.E.C. (The Executive Committee) Ltd. June 2006 - September 2007
SCE Lifeworks August 2002 - February 2006
Skills
Customer Service, Staff Supervision, Coordination, Planning, Budgeting, Retail, Change Management, Problem Solving, Marketing Communications, Market Research, Office Management, Vendor Relations, Project Planning, Project Coordination, Project Implementation, Event Planning, Event Management, Budget Management, Facilities Management, Procurement, Development & delivery..., Budgets, Marketing, Process Improvement, Administration, Software Documentation, Customer Satisfaction, Team Building, Events Coordination, Employee Training, SharePoint, Process Scheduler, Sales, Public Speaking, Public Relations, Contract Negotiation, Operations Management, Health and Safety, Accounting
Education
Red River College 2011 — 2013
Management Development Certificate
University of Manitoba
B.A., Psych
Merck September 2014 - Present
Merck September 2012 - September 2014
Hospira July 2011 - September 2012
Biomerieux 2006 - July 2011
Talecris Biotherapeutics, Inc. June 2006 - September 2006
Acusphere, Inc. April 2006 - June 2006
PharmEng Technology 2005 - 2006
Wyeth 2005 - 2006
Hospira 2004 - 2005
North Carolina State University 2001 - 2004
Skills
Cleaning Validation, Compliance, Quality Assurance, Quality Systems, Quality Engineering, Process Improvement, Process Development, CIP, Auditing, Process Validation, Validation, Project Coordination, Project Planning, Six Sigma, Green Belt, CQE, Sterilization, Risk Management, GMP, Quality System, Change Control, Technology Transfer, Process Simulation, FDA, V&V, Quality Control, CAPA, Process Engineering, 21 CFR Part 11, Aseptic Processing, Software Documentation
Education
North Carolina State University 2000 — 2004
Materials Science and Engineering, Materials Science
NHP Consulting Inc. February 2014 - Present
Atrium Innovations January 2013 - January 2014
Seroyal International (Subsidiary of Atrium Innovations) July 2010 - December 2012
Seroyal International (Subsidiary of Atrium Innovations) February 2007 - June 2010
PharmEng Technology January 2006 - January 2007
PharmEng Technology January 2005 - December 2005
PharmEng Technology February 2002 - December 2004
Derma Sciences (Dumex Medical) October 2000 - January 2002
Becton Dickinson March 2000 - October 2000
Becton Dickinson August 1999 - March 2000
Skills
Quality Assurance, Cleaning Validation, GMP, CAPA, Auditing, FDA, Regulatory Affairs, Quality Auditing, Quality System, Validation, Change Control, Sop, Biotechnology, Regulatory Submissions, SOP
Education
Laurentian University/Université Laurentienne
Bachelor of Science (B.Sc.), Major Biology / Minor Chemistry
Toronto Institute of Pharmaceutical Technolgy (TIPT)
Diploma, Pharmaceutical Quality Assurance
Concentric BioPharmaceutical Services 2007 - Present
Precision Stability Storage, LLC 2007 - Present
PharmEng Technology 2005 - 2007
Serentec Inc 2000 - 2002
Skills
Pharmaceutical Industry, Business Process..., Business Analysis, Management Consulting, Change Management, Business Intelligence, Project Management, Strategy, SDLC, Requirements Analysis, Business Strategy, ERP, Temperature & Humidity, cGMP practices, Stability Programs, Facility Start-up, Business Development, Computer System..., Validation, SOP Development, Internal Audit, FDA, SOP, Biotechnology
Education
East Carolina University
Coastal Carolina Community College
PharmEng Technology August 2014 - Present
Patheon December 2013 - July 2014
CIBA Vision January 2013 - December 2013
Pharmatec Pakistan (Pvt) Ltd July 2012 - January 2013
OTSUKA PHARMACEUTICAL S.A. November 2011 - May 2012
Apotex Inc. June 2011 - November 2011
Roche January 2000 - May 2011
Roche September 2007 - August 2009
Roche January 2003 - August 2007
Engineers United Co. January 1999 - December 1999
Skills
•Project Management •..., •Preventive..., cGMP practices, Serialization, GAP, GEP, 21 CFR Part 11, SAP, BPCS, Forecasting, ISO 14001, OSHA Certified, Occupational Health, Risk Management, FDA, Management, Pharmaceutical Industry, CAPA, GMP, Security, Validation, Regulatory Affairs, Cleaning Validation, Sop, Training, Project Management, V&V, Engineering, Process Improvement, Quality System, SOP, Negotiation, Quality Assurance, Quality Control, Technology Transfer, Pharmaceutics, Cross-functional Team..., Manufacturing, Six Sigma, Medical Devices, Change Control, Leadership, Computer System..., Continuous Improvement, Biotechnology, Regulatory Requirements, Quality Auditing, Product Launch, Pharmaceutical Sales, Quality Management
Education
NED University of Engineering and Technology 2000 — 2003
Master of Engineering (M.Eng.), Environmental Engg., First Division and cGPA 3.0
NED University of Engineering and Technology 1993 — 1997
Bachelor's degree, Mechanical Engineering, First Division
Barry-Wehmiller Design Group April 2013 - Present
PharmEng Technology October 2012 - April 2013
Integrated Commissioning & Qualification, Corp. December 2009 - November 2012
Stryker Biotech May 2008 - December 2009
Validation Technologies, Inc. January 2006 - May 2008
Wyeth BioPharma October 2000 - January 2006
Nashua Corp 1997 - 2000
Skills
Process Validation, Validation, cGMP, Biotechnology, GMP, Process Engineering, Metrology, Delta V, V&V, Biopharmaceuticals, Manufacturing, Commissioning, FDA, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Computer System..., GAMP, GxP, Quality System, Sop, Quality Assurance, Troubleshooting, CAPA, Medical Devices, Software Documentation, Regulatory Affairs, ISO 13485, GLP, Process Simulation, LIMS, Calibration, Testing, Technology Transfer, Cleaning Validation, Engineering, Quality Auditing, Aseptic Processing, Root Cause Analysis, Regulatory Requirements, Quality Management, Lifesciences, HPLC, Pharmaceutics, PLC, Sterilization, Chromatography, Cell Culture, Regulatory Submissions, R&D
Education
Merrimack College 1992 — 1995
Electrical and Electronics Engineering
Dalton Pharma Services February 2015 - Present
MRH Biotechnical Ltd. January 1990 - Present
PharmEng Technology August 2014 - February 2015
Therapure Biopharma Inc March 2013 - August 2014
Skills
Project Management, Requirements Analysis, SDLC, Calibration, Facilities Management, Instrumentation, Water Treatment, Validation, Quality Assurance, GMP, Steam, Pharmaceutical Industry, Biopharmaceuticals, Process Engineering, Quality System, CAPA, Biotechnology, SOP, Troubleshooting, Sterilization, Quality Control, 21 CFR Part 11, Technology Transfer, FDA, Change Control
Education
Humber College 1980 — 1983
Electro-Mechanical Engineering Technology, Technology and Automation
ProPharma Group February 2014 - Present
PharmEng Technology January 2012 - Present
Black Diamond Networks 2015 - 2015
Black Diamond Networks 2015 - 2015
Black Diamond Networks 2015 - 2015
LifeCell Corporation October 2009 - July 2010
Skills
Validation, Computer System..., 21 CFR Part 11, GMP, Change Control, Cleaning Validation, Aseptic Processing, Protocol
Education
Temple University 2003 — 2007
Bachelor of Science (BS), Anthropological Human Biology and Criminal Justice
CRLS November 2012 - Present
PharmEng Technology December 2012 - Present
PharmEng Technology July 2011 - November 2012
Protox Therapeutics November 2007 - December 2010
Cancer Research Institute, Scott & White Memorial Hospital, TX, USA August 2006 - October 2007
Cancer Research Institute, Scott & White Memorial Hospital, TX, USA August 2005 - July 2006
Tata Memorial Hospital, Mumbai, India January 2005 - July 2005
Skills
R&D, Clinical Operations, Clinical Development, Clinical Research, Drug Development, CMC Regulatory Affairs, Quality Assurance, Regulatory Affairs
Education
University of Mumbai 2000 — 2005
Ph.D, Cancer Biology
University of Pune 1997 — 1999
M.Sc., Biochemistry
University of Pune 1994 — 1997
B.Sc., Chemistry
Steel Rail Entertainment Inc. June 2011 - Present
Ineco Inc February 2000 - Present
National Fitness Training Inc. August 2010 - August 2012
Knightsbridge Human Capital Solutions August 2009 - February 2011
PharmEng Technology June 2005 - June 2009
Centrinity 1999 - 2007
Higher Education Finance May 1997 - November 1999
ITI Education Corp (operated as "ITI Information Technology Institute) March 1995 - October 1998
Ivy Computer Centers 1975 - 1985
Skills
Private Equity, Mergers & Acquisitions, Business Planning, Leadership, Mergers, Investments, Capital Markets, Business Strategy, Entrepreneurship, Business Development, Strategic Partnerships, Finance, Strategy, Management, Executive Management, Training, Management Consulting, Negotiation, Start-ups
Education
Queen's University 1973 — 1978
Hon B-Com, Accounting and Finance
Lausanne Secondary 1972 — 1973
Ridley College 1966 — 1972
PharmEng Technology 1997 - Present
ACCE - Association of Chinese Canadian Entrepreneur 2010 - 2014
Taro Pharmaceuticals 1995 - 1997
John Brown Engineering & Contractors 1994 - 1995
Purdue Frederick Inc. (now Purdue Pharma) and NuPharm Inc. 1989 - 1994
Glaxo Canada Inc. (now GSK) 1988 - 1989
Connaught Laboratories Limited (now Sanofi-Pasteur) 1986 - 1988
Ontario Cancer Institute (Princess Margaret Hospital) 1985 - 1986
Education
University of Michigan
Bachelor of Science, Chemical Engineering
University of Toronto
Master of Science, Chemical Engineering
University of Toronto
Master of Business Administration
Sanofi Pasteur July 2015 - Present
PharmEng Technology May 2015 - Present
CIBA Vision February 2006 - December 2014
Apotex Inc. 2000 - 2005
Apotex Inc. 1997 - 2000
Apotex Inc. 1995 - 1997
Janssen-Ortho 1994 - 1995
GlaxoSmithKline 1992 - 1994
Rothmans 1991 - 1991
Skills
21 CFR Part 11, Computer System..., Validation, FDA, GMP, Quality Systems, GLP, LIMS, cGMP, Quality Assurance, SOP, GAMP, Compliance, GxP, Change Control, Document Management, Medical Devices, Documentation, Calibration, Testing, Automation, Life Sciences, Software Validation, Quality Management, Process Development, Pharmaceuticals, ISO, SDLC, Troubleshooting, HPLC, SAP, Change Management, Requirements Analysis, Data Management, Pharmaceutical Industry, CAPA, Sop, Quality System, Software Documentation, Regulatory Requirements, Regulatory Affairs, Quality Auditing, ISO 13485, Pharmaceutics, Quality Control, Technology Transfer, Root Cause Analysis, Laboratory, Analytical Chemistry, GCP
Education
Electrical College of Canada 2014 — 2015
Electrician Pre Apprenticeship
York University 1996 — 2003
Computer and Information Sciences, General
Seneca College of Applied Arts and Technology 1993 — 1994
BCT, Biochemical Technician
Seneca College of Applied Arts and Technology 1989 — 1993
PMTC, Pharmacuetical Technology
Carleton University 1987 — 1989
Criminology
Brebeuf College School
Sequence Quality and Compliance Services June 2014 - Present
Reynolds American, Inc. June 2014 - Present
Black Diamond Networks April 2013 - June 2014
BD March 2010 - April 2013
Invensys Operations Management February 2007 - January 2010
PharmEng Technology August 2006 - February 2007
Hospira May 2003 - August 2006
Skills
Quality Control, Quality Assurance, 21 CFR Part 11, Biotechnology, V&V, Change Control, GxP, FDA, Sop, Aseptic Processing, Root Cause Analysis, Cleaning Validation, CAPA, Quality Auditing, ISO 13485, Minitab, Technical Writing, Equipment Qualification, cGMP manufacturing, cGMP practices, Protocol, SOP development, Computer System..., Validation, FDA GMP, Quality System..., Regulatory Requirements, Regulatory Compliance, Process Improvement, Testing, SOP
Education
North Carolina State University 1996 — 2001
Bachelor of Science (B.S.), Materials Science & Engineering
Temple University
Master of Science (M.S.), Quality Assurance & Regulatory Affairs
Peak Performance Global Services, LLC January 2014 - Present
PharmEng Technology January 2012 - January 2014
Biogen Idec 2010 - 2011
Azzur Group 2010 - 2011
Sanofi Pasteur 2006 - 2011
Jacobs Engineering 2003 - 2005
cGMP Validation LLC 2000 - 2003
Merck 1994 - 2002
Raytheon Engineers 1990 - 1998
United States Air Force 1976 - 1982
Skills
Business Development, Project Management, Team Building, Computer System..., Change Control, V&V, 21 CFR Part 11, Validation, GxP, CAPA, FDA, GMP, Sop, Biopharmaceuticals, Pharmaceutical Industry, Quality Management, Biotechnology, GAMP, Quality System, Management, Vaccines, Manufacturing, Commissioning, Technology Transfer, Aseptic Processing, Six Sigma, GLP, Industrial Engineering, Regulatory Affairs, Project Engineering, Root Cause Analysis, Medical Devices, Quality Assurance, Quality Control, Cleaning Validation, ISO 13485, Engineering, Strategy, Pharmaceutics, LIMS, Process Simulation, Regulatory Requirements, Lifesciences, Regulatory Submissions, Quality Auditing, Process Engineering, R&D, Drug Development, Document Management, People Skills
Education
Lehigh County Community College 1978 — 1982
Business Management
Troy State University 1977 — 1978
Business Management
PharmEng Technology October 2011 - Present
Patheon Inc. June 2005 - September 2008
Sanofi Pasteur May 2007 - August 2007
Self-Employed January 2002 - April 2007
Skills
Biotechnology, Life Sciences, FDA, Validation, Microbiology, Computer System...
Education
University of Ontario Institute of Technology 2007 — 2011
Honours degree in Bachelors of Science, Biology
Durham College 2004 — 2007
Advanced College Diploma, Biotechnology Technologist
Prollenium Medical Technologies, Inc. June 2009 - Present
PharmEng Technology August 2007 - June 2009
Kent State University August 1998 - May 2004
University of North Carolina at Chapel Hill 1994 - 1997
Skills
Analytical Chemistry, UV/Vis, HPLC, Electrochemistry, Chromatography, R&D, Chemistry, Mass Spectrometry, Spectroscopy, GLP, Method Development, Validation, Medical Devices, IR, Laboratory, Programming, Wet Chemistry, Chemstation, Gas Chromatography, Science, Research, Purification, Dissolution, Sop
Education
York University 1986 — 1994
Ph.D., Chemistry
University of Toronto - University College 1982 — 1986
B.Sc., Biochemistry - Chemistry
Kent State University
PharmEng Technology September 2015 - Present
Board Member, Canadian Society for Pharmaceutical Sciences January 2015 - Present
Mahal Consulting June 2014 - Present
Patheon Inc. August 2010 - June 2014
Patheon Inc. November 2000 - August 2010
BodyCote Ortech 1997 - 2000
Taro Pharmaceuticals 1996 - 1997
Cosmetica Laboratories Inc. 1995 - 1996
SynProTec 1989 - 1995
Skills
Product Development, Supply Chain Management, Team Building, Management, Risk Management, Kaizen, Pharmaceutical Industry, Technology Transfer, Biotechnology, Pharmaceutics, Commercialization, Customer Service..., Project Management, Business Development, FDA, R&D, Manufacturing, GMP, Validation, SOP, Strategy
Education
The University of Salford 1982 — 1987
Ph.D. & Post Doc., Organic Chemistry
De Montfort University 1978 — 1982
BSc (Hons), Applied Chemistry
The Hospital for Sick Children September 2013 - Present
The Hospital for Sick Children September 2006 - September 2013
Apotex Inc. November 2004 - September 2006
Canadian Blood Services May 2003 - September 2004
PharmEng Technology August 2001 - May 2003
Skills
Quality System, Validation, FDA, Medical Devices, CAPA, ISO 13485, Biomedical Engineering, Biotechnology, GMP, Sop, Lifesciences, Regulatory Affairs, Change Control, GLP
Education
University of Guelph
Hon B.Sc. Engineering (Biological), Biomedical Engineering
INDEPENDENT CONSULTANT; EvoRegnA® Consulting Inc. November 2013 - Present
Free lance consultant providing services to the pharma, biotech, medical marijuana,CPG, food areas August 2009 - Present
Apollo Health and Beauty Care May 2012 - May 2012
Teva Pharmaceuticals June 2010 - September 2011
Purdue Pharma (Canada) August 2002 - May 2011
PharmEng Technology January 2010 - August 2010
Teva Canada March 2002 - August 2002
Purdue Pharma Canada March 2001 - August 2002
Schneider Electric Industrial Services July 1998 - March 2001
TORPHARM-Pharmaceuticals manufacturer, division of Apotex Inc. August 1997 - July 1998
Skills
GMP, Validation, Continuous Improvement, Pharmaceutical Industry, Manufacturing, Change Management, FDA, Engineering, Process Improvement, CAPA, Strategic Planning, Lifesciences, Medical Devices, Quality Control, Quality System, SOP, Technology Transfer, Program Management, Industrial Engineering, Production, cGMP, Process Engineering, Security Management, Business Process..., V&V, Manufacturing Management, Inspection, Logistics Management, Packaging, Process Optimization, Facilities Management, Manufacturing..., Biotechnology, Life Sciences, Quality Systems, Compliance Management, Product Launches, New Business Development, Management, Business Strategy, Leadership, Cross-functional Team..., Project Management, Facilities Engineering, Construction Management, Engineering Management, Strategy, Quality Assurance, Strategic Partnerships
Education
PSG, ISPE, PMAC Annual conferences and seminars 1981 — 2014
Educational credits from attending PSG, ISPE, PMAC technical conferences, courses, seminars, etc.
ISPE Annual Technical Conferences 1976 — 2014
Educational credits from participating in ISPE annual technical conferences
Various 1988 — 2008
Seneca College of Applied Arts and Technology 1988 — 2002
Various management and technical courses
PMAC 1978 — 2002
Semi-annnual tehnical conferences. Made numerious presentations on a variety of topics.
Concordia University
BA, Liberal Arts, Economics, Sociology, etc.
McGill University
B.Eng., Chemical Engineering
McGill University
B.Eng. Chemical, MBA Program; Economics, Finance, Marketing, Operations Research, etc.
Various
N/A, Languages
kishinev elementary #39
IPS-Integrated Project Services March 2014 - Present
PharmEng Technology May 2012 - March 2014
Lyophilization Technology Inc. May 2010 - April 2012
Drexel University College of Medicine, Molecular Biology June 2009 - August 2009
Lyophilization Technology Inc. September 2008 - March 2009
Vector Marketing 2009 - 2009
Laureate Biopharmaceutical Services September 2007 - March 2008
Community College of Philadelphia September 2006 - April 2007
Skills
Validation, Life Sciences, cGMP, Microsoft Office, Chromatography, Cell Culture, Manufacturing, Process Improvement, Biotechnology, SOP, GMP, Public Speaking, Technical Writing, Lyophilization, Sop, V&V, Lifesciences, Positive Personality, Organizational..., Team Leadership, Change Control, Laboratory, Process Simulation, Aseptic Processing, Western Blotting, CAPA, Formulation, 21 CFR Part 11, GLP, Technology Transfer, Biopharmaceuticals, FDA, GxP, Pharmaceutical Industry, Vaccines, Organic Chemistry, Assay Development, Sterilization, HPLC, Microbiology, Regulatory Affairs, Trackwise
Education
University of the Sciences in Philadelphia 2014 — 2016
Master of Business Administration (M.B.A.), Pharmaceutical and Healthcare Business, Current GPA: 3.9
Drexel University 2005 — 2010
Biological Sciences, Biological and Physical Sciences
PharmEng Technology June 2005 - Present
Alcon, a Novartis company January 2009 - April 2014
CIBA Vision July 2005 - December 2008
Apotex Inc. March 2005 - June 2005
Alfa Laval October 2001 - March 2005
Eli Lilly Italia March 2003 - March 2004
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2002 - February 2003
Pfizer March 2002 - November 2002
Skills
Project Management, Quality Management, Computer System..., SDLC, Software Quality..., Quality Assurance, Validation, Compliance, 21 CFR Part 11, GxP, cGMP practices, Process Automation, Process Control, Control Engineering, Control Panel Design, PLC Programming, P&ID, Telecommunications, FDA, Quality System, Manufacturing, SOP
Education
Ryerson University 1997 — 2001
Bachelor of Engineering (B.Eng.), Computer and Electrical
Teva Canada April 2015 - Present
Roundabout Canada December 2013 - Present
Sanofi Pasteur November 2014 - April 2015
PharmEng Technology September 2014 - April 2015
Purdue Pharma February 2009 - April 2014
Impopharma January 2006 - February 2009
Vita-Tech Laboratories February 2006 - August 2006
Young & Young Trading Company October 2005 - January 2006
TN INC March 1997 - November 2000
Skills
Pharmaceutical Industry, GMP, HPLC, Quality Assurance, Formulation, Validation, GLP, FDA, LIMS, Data Analysis, Sop, 21 CFR Part 11, Cleaning Validation, V&V, Computer System..., NuGenesis SDMS, Empower Software, Labware LIMS, Building Management...
Education
Harvard University 2014 — 2019
Master's Degree, Liberal Arts - Extension Studies in Information Management Systems concentration
Wilfrid Laurier University 2010 — 2014
Master's Degree, Business Administration and Management, CMA
Seneca College of Applied Arts and Technology 2006 — 2010
Certificates / Graduate Certificate, Pharmaceutical
University of Waterloo
Bachelor of Science
Albert Campbell Collegiate Institute
High School
Sanofi Pasteur August 2011 - Present
PharmEng Technology March 2003 - July 2011
Education
Queen's University
Azzur Group May 2014 - Present
Experis Manpower February 2014 - March 2014
Versa Engineering & Technology September 2013 - January 2014
TalentBurst, Inc. (Consultant) January 2013 - June 2013
PharmEng Technology November 2008 - September 2011
InfoQuest Consulting Group December 2010 - February 2011
Ryzen Solutions (Broncus Technologies, Inc.) July 2008 - November 2009
Tac Worldwide (Genentech) January 2008 - March 2008
Adecco Technical (Novartis, Inc., Bayer Healthcare) July 2007 - October 2007
Genentech November 2005 - July 2006
Skills
Validation, GMP, FDA, Sop, Quality System, CAPA, Quality Assurance, V&V, Biotechnology, Medical Devices, Biopharmaceuticals, LIMS, Computer System..., Software Documentation, Quality Control, Clinical Trials, GAMP, Change Control, 21 CFR Part 11, ISO 13485, HPLC, Pharmaceutics, Laboratory, GLP, GxP, Regulatory Affairs, Technology Transfer, Regulatory Requirements, Pharmaceutical Industry, Cleaning Validation, Chemistry, Regulatory Submissions, Lifesciences, Document Management, GCP, R&D, Technical Writing, SOP, Life Sciences
Education
San Diego State University-California State University
Bachelor's Degree, Chemistry
Skyline College 2007 — 2007
Biotechnoloy Manufacturing Certificate, BioManufacturing / Biotechnology
St. Michael's High, Los Angeles, CA
Johnson Controls July 2011 - Present
Monosol Rx, LLC February 2011 - July 2011
Advanced Technology Services July 2010 - February 2011
Abraxis BioScience February 2010 - May 2010
Covance January 2009 - April 2009
Corium International September 2008 - December 2008
Pfizer May 2003 - May 2008
Apotex Inc. December 2002 - May 2003
PharmEng Technology November 2002 - December 2002
SRP Control Systems Ltd. March 2001 - September 2002
Skills
Calibration, Metrology, Analytical Chemistry, Quality Assurance, Spanish-speaking, Measurement Uncertainty, Measurement System..., HPLC, Chemical Engineering, Laboratory Equipment, Instrumentation, GMP, Sop, Change Control, FDA, Laboratory, Manufacturing, Medical Devices, Six Sigma, Pharmaceutical Industry, Quality System, CAPA, Root Cause Analysis, ISO, SOP
Education
Ryerson University 1985 — 1990
Bachelor of Engineering (B.Eng.), Chemical Engineering
Brevitas Consulting Inc. December 2012 - Present
PharmEng Technology September 2011 - December 2012
Apotex Inc. February 2010 - September 2011
Apotex Inc. September 2008 - August 2009
Sanofi Pasteur May 2007 - December 2007
Skills
Change Control, GMP, Validation, Pharmaceutical Industry, Sop, FDA, Quality System, Quality Assurance, Biotechnology, Computer System..., CAPA, 21 CFR Part 11, GxP, LIMS
Education
University of Toronto - School of Continuing Studies 2012 — 2013
Certificate in Project Management, Project Management
Ontario Institute of the Purchasing Management Association of Canada 2012 — 2012
OIPMAC-HSCN Healthcare Certificate in Strategic Sourcing, Healthcare Strategic Sourcing
Seneca College of Applied Arts and Technology 2008 — 2010
Industrial Pharmaceutical Technology Certificate, Industrial Pharmaceutical Technology Certificate
University of Guelph 2003 — 2008
B.Eng (Co-op), Biological Engineering, Bioprocessing
PharmEng Technology 2011 - 2014
PharmEng Technology 2011 - 2014
BVS - part of V-GROUP September 2003 - March 2009
Israel Aerospace Industries Ltd. 1999 - 2002
Skills
Analysis, Mechanical Engineering, Commissioning, Engineering, Project Management, Management, Manufacturing, MS Project, Project Planning, Product Development
Education
Technion - Israel Institute of Technology 1995 — 1999
B.Sc., Mechanical Engineering
Acces
Rogozin
Sanofi Pasteur March 2007 - Present
Sanofi Pasteur March 2007 - Present
SNC-Lavalin September 2013 - Present
PharmEng Technology March 2007 - September 2013
Sanofi Pasteur 2010 - 2011
Purdue Pharma 2007 - 2008
Patheon 2007 - 2008
Ming Pao Daily Toronto May 2006 - March 2007
University of Guelph 2005 - 2005
Seneca College of Applied Arts and Technology 2002 - 2003
Skills
Computer System..., 21 CFR Part 11, Change Control, Validation, Biopharmaceuticals, Sop, GMP, FDA, GLP, Quality System, Biotechnology, Quality Assurance
Education
University of Guelph 2003 — 2006
Honor BSc., Biomedial Toxicology
Seneca College of Applied Arts and Technology 2000 — 2003
CLP Dip., Chemical Lab Technician (Pharmaceutical)
McMaster University 1998 — 2000
Enginnering
AYJ SS
PharmEng Technology January 2015 - Present
Therapure Biopharma Inc April 2014 - January 2015
Sanofi Pasteur 2015 - 2015
Sanofi Pasteur 2015 - 2015
GlaxoSmithKline March 2006 - December 2013
Apotex Inc. May 2002 - March 2006
Patheon Inc 1999 - 2002
Patheon Inc 1999 - 2002
Skills
Validation, Project Management, Pharmaceutical Industry, Engineering, Change Control, Aseptic Processing, Quality System, V&V, Computer System..., FDA, Sop, Manufacturing, Quality Assurance, Software Documentation, SOP, GMP
Education
McMaster University 1994 — 1998
Engineering, Chemical Engineering
Imaging Endpoints March 2015 - Present
Octapharma Plasma, Inc. February 2014 - February 2015
PharmEng Technology August 2012 - February 2014
Pfizer (King Pharmaceuticals, Inc.) May 2004 - August 2012
cGMP Validation May 1997 - May 2004
CRB Consulting Engineers May 1993 - May 1997
Integrated Health Services May 1990 - May 1994
Peters-Eichler 1986 - 1990
Haberberger Design, Inc. (Consulting Engineers/Construction Managers) May 1984 - May 1986
Harley Gordon and Associates, Inc. May 1981 - May 1984
Skills
Demonstrated Leadership..., Project Management..., Expert FDA Regulated..., Validation, 21 CFR Part 11, GMP, FDA, LIMS, GLP, SCADA, Documentum, PLC, Quality Center, Wonderware, Building Automation, cGMP, CAPA, SOP, Computer System..., Pharmaceuticals, Change Control, Quality Assurance, Quality Systems, Process Validation, GxP, GAMP, Manufacturing, Six Sigma, Automation, Documentation, Document Management, ISO, Continuous Improvement, Compliance, Testing, Cleaning Validation, Life Sciences, Technical Writing, Quality Management, Software Validation, Commissioning, Root Cause Analysis, Quality Auditing, Project Management, Software Documentation, Quality System, V&V, GCP, Pharmaceutical Industry, Aseptic Processing
Education
University of Kansas 1976 — 1981
Bachelor of Science
Kansas State University 1979 — 1981
BS, Geography
University of Phoenix 2007 — 2009
MBA, Business
PharmEng Technology September 2011 - February 2012
Kelly Services November 2010 - May 2011
Sanofi Pasteur Limited June 2006 - October 2009
Kelly Scientific Services October 2005 - March 2006
Abbott Laboratories Ltd December 2003 - May 2004
Intelligene Expressions Inc May 2000 - August 2002
Bristol Myers Squibb July 1996 - March 2000
Skills
Validation, Protocol, Quality Control, Software Documentation, Six Sigma, SAP, Risk Assessment, Data Analysis, Materials Management, Research, Workshop Facilitation, Inventory Management, Customer Service, Personnel Management, Directing, GMP, CAPA, Sop, Change Control, FDA
Education
University of Alberta 2003 — 2003
Open study Courses, Biotechnology and Immunology
Karachi University 1990 — 1995
Masters, Microbiology
PharmEng Technology March 2012 - Present
cGMP Validation LLC 2006 - 2011
Sanofi 1995 - 2006
US Navy Retired 1964 - 1994
Skills
Customer Service, Microsoft Excel, Microsoft Office, Microsoft Word, Validation, Manufacturing, Commissioning, HVAC, Steam, Biotechnology, V&V, Pharmaceutical Industry, Computer System..., GMP, 21 CFR Part 11, Quality Assurance, FDA, Change Control
Education
MidAmerica Nazarene University 1998 — 1999
Management of Human Resources
Sanofi Pasteur December 2013 - Present
Sanofi Pasteur May 2007 - December 2013
Sanofi Pasteur 2006 - 2007
PharmEng Technology 2003 - 2006
Skills
Aseptic Processing, Change Control, FDA, GLP, GMP, Pharmaceutical Industry, Sop
Education
McMaster University 1998 — 2002
B.Sc., Life Sciences - Honours Biology
Wexford Collegiate Institute 1995 — 1998
High School
St. Scholastica's College-Manila, Philippines 1993 — 1994
B.Sc., 1st year-Psychology
PharmEng Technology March 2010 - Present
Modern Age Computer Consultants Inc. February 2006 - February 2010
Education
City University of New York 2001 — 2003
M.Sc, Computer Science
PharmEng Technology 2012 - Present
PharmEng Technology 2005 - 2012
Skills
GxP, Validation, FDA, Computer System..., GMP, Change Control, Sop
Education
Seneca College of Applied Arts and Technology
Industrial Pharmaceutical Technology
Shanghai University of Science and Engineering
Bachelor's degree, Chemical Engineering
Universal Quality Solutions Inc. February 2012 - Present
Sanofi Pasteur 2009 - Present
PharmEng Technology August 2006 - January 2012
PharmLink Inc 2005 - 2006
Skills
Validation, Change Control, Computer System..., GMP, 21 CFR Part 11, HPLC, FDA, V&V, GxP, Quality Assurance, Sop, Technology Transfer
Education
Adamson University
Bachelor of Engineering (B.Eng.), Chemical Engineering