Validation Technologies, Inc.
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Validation Technologies, Inc. Employees
Validation Technologies, Inc. May 2012 - Present
Cangene Corporation February 2002 - February 2012
ProPharma Group 2012 - 2012
IBM Global Services February 1998 - August 2000
Rescom Ventures June 1996 - December 1997
Skills
Change Control, GMP, Quality Assurance, Validation, Software Installation, Programming, Quality Systems, Hardware, SQL, Operating Systems, Administration, SQL Server, Documentation, Word, Problem Solving, Customer Relations, GxP, Computer System..., GLP, 21 CFR Part 11, cGMP, SOP, Software Validation, ERP, Risk Management, User Acceptance Testing, GAMP, FDA, LIMS, GCP, SDLC, Change Management, Testing, Process Development, Troubleshooting, Requirements Analysis, Visio, Software Quality..., Trackwise, Technology Transfer, Quality System, Customer Service, Pharmaceutical Industry, Aseptic Processing, Microsoft Word, V&V, Process Simulation, Quality Management, Biotechnology, ISO 13485
Education
University of Winnipeg / Midwestern School of Business and Technology 2000 — 2002
Certificate in Management / Diploma in Database Administrator, Database Administrator
Red River College 1994 — 1996
Computer Analysts Programer, Computer Programing
Red River College 1985 — 1987
Business Administration, Adminsitration and Marketing
Fitbit April 2015 - Present
Sonic Boom Wellness 2011 - 2015
Validation Technologies, Inc. October 2010 - October 2011
Skills
Customer Service, PowerPoint, Event Planning, Microsoft Word, Microsoft Office, Recruiting, Custom Communication..., Project Management, Office Administration, Marketing Strategy, Blogging, Hospitality, Public Relations, Event Management, Creative Writing, Outlook, Team Leadership, Marketing, Management, Administrative..., Sales Management, Facebook, Online Advertising, Public Speaking, Employee Relations, Advertising, Microsoft Excel, Social Media Marketing, System Administration, Strategic Planning, Leadership Development, Marketing Communications, Fundraising, Editing, Email Marketing, Social Networking, Team Building, Training, Account Management, Social Media, Sales, Customer Satisfaction, Coaching, Data Analysis, Research, Leadership, Troubleshooting, Media Relations, Inventory Management, Newsletters
Education
San Diego State University-California State University 2006 — 2010
Communications, Journalism & Media Studies, Communication, Magna Cum Laude
VFA, an Accruent Company September 2014 - Present
Validation Technologies, Inc. February 2013 - April 2014
Hallam-ICS April 2012 - January 2013
Strategic Building Solutions November 2009 - June 2011
Canyon States Engineers July 2004 - October 2009
Adams and Associates February 2003 - June 2004
Skills
Design Specifications, Technical Presentations, HVAC Air System Design, HVAC Hydronic Systems, HVAC LP & HP Steam..., Technical Report Writing, AutoCAD drawings, MEP Installation..., MEP Functional Tests, Project Engineering, New Business Development, HVAC, Project Management, Project Planning, AutoCAD, Functional Requirements, Technical Reports, Commissioning, Hydronic, Engineering, Management, System Design, Manufacturing, Validation, Construction, MEP, Software Documentation, CAD, Energy, Piping
Education
University of Arizona
BSME, Applied heating and air conditioning systems, heat transfer, fluid mechanics
SanDiego.com 2010 - 2011
Novint Technologies 2007 - 2009
Volt Services 2006 - 2007
Validation Technologies, Inc. 2001 - 2005
Culinary Concepts 1994 - 1995
Uni-Vite 1990 - 1992
DATASAT Company 1990 - 1990
Skills
Flexibility, Event Planning, Customer Driven, Microsoft Office, Food & Beverage, Hospitality, Catering, Microsoft Word, Time-efficient, Close Attention to..., Efficiency, Organization, Multi-tasked, Reliability, Communication
Education
San Diego State University-California State University
Certificate, Meeting and Event Planning
San Diego State University-California State University
Bachelor's degree, Business Administration, Marketing
Agilent Technologies January 2014 - Present
Dako May 2009 - January 2014
Validation Technologies, Inc. December 2007 - May 2009
PharmBio Inc. On Site Baxter June 2007 - December 2007
PharmBio Inc. (onsite Amgen) August 2005 - June 2007
PharmBio Inc. March 2002 - October 2003
Amgen May 2001 - March 2002
Skills
Microsoft Office, Management, Microsoft Excel, Microsoft Word, Research, PowerPoint, Leadership, Training, Validation, Testing, Manufacturing, GMP, SOP, Quality Assurance, FDA, Pharmaceutical Industry, Quality System, Biotechnology, Process Improvement, Medical Devices, 21 CFR Part 11, ISO 13485, CAPA, Change Control, Life Sciences, Quality Control, Biopharmaceuticals, Technology Transfer
Education
University of California, San Diego 2003 — 2005
Bachelor of Science (B.S.), Biology, General
Moorpark College 1998 — 2002
Associate of Arts (A.A.), Liberal Arts and Sciences/Liberal Studies, 3.75 GPA
Self-employed 1988 - Present
Illumina June 2014 - Present
Validation Technologies, Inc. January 2006 - April 2013
Accumetrics April 2012 - March 2013
Genoptix January 2012 - March 2012
Self-Employed August 2007 - January 2012
Cameron Health April 2007 - August 2007
Allergan January 2006 - March 2007
Gen-Probe 2002 - November 2005
Gen-Probe May 2000 - 2002
Skills
Computer System..., Quality Assurance, 21 CFR Part 11, Quality System, V&V, CAPA, FDA, LIMS, Validation, Medical Devices, Pharmaceutical Industry, Biotechnology, Regulatory Requirements, SDLC, GxP, ISO 13485, ISO 14971, IEC 62304, Change Control, GAMP, NCMR, FMEA, Part 820, 21 CFR 58, DMAIC, SOPs, Microsoft Word, Sop
Education
Duke University
Bachelor of Science (BS), Zoology, Cellular and Sub-cellular Program
Cal Poly Pomona
Santa Ana College
Computer Programming
West Valley College
Small Business Administration / Management
Palomar College June 2013 - Present
Validation Technologies, Inc. November 2013 - February 2014
Texas Roadhouse June 2012 - August 2012
PBM Images January 2010 - March 2010
Skills
Customer Service, Psychology, Learning Quickly, Quick Thinker, Positive Team Player, Intercollegiate..., Athletics, Food Service, Cash Handling Experience, American Sign Language, Sports Enthusiast, Enthusiastic..., Communication Skills, Microsoft Word, Microsoft Office, Microsoft Excel, Social Media, Social Skills, Sports
Education
The Ohio State University 2011 — 2013
Bachelor of Arts (BA), Psychology
Palomar College 2009 — 2011
Associate of Arts (AA), General Studies
Validation Technologies, Inc. September 2014 - Present
Validation Technologies, Inc. September 2013 - Present
WyzAnt Tutoring November 2012 - Present
Reuben H. Fleet Science Center August 2013 - September 2013
Reuben H. Fleet Science Center May 2013 - August 2013
Advantage Sideout January 2013 - May 2013
University of Windsor September 2004 - August 2012
University of Windsor September 2004 - May 2012
Skills
PCR, Molecular Biology, Tissue Culture, Cell Culture, Flow Cytometry, Genetics, Microarrays, RNA isolation, Teaching, Science, qPCR, DNA, Biochemistry, Cell Biology, Western Blotting, RT-PCR, Immunohistochemistry, Transfection, Immunofluorescence, Molecular Cloning, DNA extraction, Mutagenesis, SDS-PAGE, Fluorescence Microscopy, Confocal Microscopy, Gel Electrophoresis, Animal Models, Molecular Genetics, Microscopy, In Vivo, Stem Cells, Regenerative Medicine, Assay Development, Data Mining, Data Analysis, Curriculum Development, Communication Skills, Organization, GSP, GMP, SOP, Scientific Writing
Education
University of Windsor 2004 — 2012
Doctor of Philosophy, Developmental Genetics
The University of British Columbia 1999 — 2003
Bachelor of Science, Animal Biology
Validation Technologies, Inc. February 2014 - Present
Stop & Shop January 2011 - December 2014
Skills
Customer Service, Project Management, Appointment Scheduling, Microsoft Office, Multi Tasking, Social Media, Coordination, Task Management, Self-starter, Front Office, Maintaining Strong..., Creative Problem Solving, Administrative..., Telephone Skills, Time Management, PowerPoint, Data Entry, Problem Solving, Training, Communication, Management, Teamwork, Administrative..., Microsoft Word, Social Networking
Education
Bridgewater State University 2011 — 2013
Bachelor of Science (BS), Psychology
GEP&cGMP Consulting Inc. April 2014 - Present
Pfizer March 2013 - February 2014
Zimmer March 2012 - December 2012
Shanghai Institutes for Biological Sciences July 2010 - March 2012
Validation Technologies, Inc. August 2009 - June 2010
Genzyme February 2010 - May 2010
Bristol Myers Squibb March 2009 - November 2009
Sanofi Pasteur June 2008 - October 2008
AVENTIS January 2007 - June 2008
Alexion Pharmaceuticals, Inc. August 2007 - November 2007
Skills
Process Validation, cGMP, Validation, Commissioning, Life Sciences, Lifesciences, GMP, FDA, Design of Experiments, Quality System, Quality Assurance, Manufacturing, V&V, 21 CFR Part 11, Sop, Computer System..., Process Engineering, Aseptic Processing, CAPA, GxP, GAMP, Change Control, Engineering, Cleaning Validation, Medical Devices, Technology Transfer, Pharmaceutical Industry, Biotechnology, Sterilization, Biopharmaceuticals, Trackwise, ISO 13485, Quality Auditing, Regulatory Affairs, Pharmaceutics, Automation, SPC, GLP, ISO, Process Simulation, LIMS, Quality Control, Vaccines, FMEA, Root Cause Analysis, Software Documentation, Regulatory Requirements, HPLC, GCP, Clinical Trials
Education
New Jersey Institute of Technology 1996 — 1998
MSIE, Industrial Engineering
New Jersey Institute of Technology 1996 — 1998
Master, Science Industrial Engineering
Universidad de Puerto Rico 1990 — 1995
BSIE, Industrial Engineering, BSIE
University of Puerto Rico Mayaguez campus 1990 — 1995
Bachelor, Science Industrial Engineering
Validation Technologies, Inc. July 2013 - Present
Novartis April 2012 - June 2013
Sandoz Pharmaceuticals April 2011 - April 2012
Pharmetics inc. April 2010 - April 2011
Pharmetics inc. July 2009 - April 2010
AGAT Laboratories January 2009 - July 2009
Phostech Lithium August 2008 - January 2009
Skills
Cleaning Validation, Sop, Change Control, GMP, HPLC, CAPA, Validation, Analytical Chemistry, CIP, SIP, Environmental..., Biotechnology, Downstream Processing, Analytical Method..., TFF, 21 CFR Part 11, GLP, Biopharmaceuticals, Chromatography, Clean Rooms, Solid Oral Dosage Forms, Equipment Validation, Process Validation, SOP, BPF
Education
McGill University 2012 — 2012
Six Sigma Green Belt
McGill University 2010 — 2010
Graduate Diploma, Management
Université de Montréal 2005 — 2008
Bsc., Chem.
Collège International Marie de France 2002 — 2005
DEC equivalent, Science
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
SAFC March 2015 - Present
Validation Technologies, Inc. October 2012 - August 2013
Sigma-Aldrich May 2007 - January 2012
Molecular Medicine BioServices August 2003 - May 2007
Selective Genetics, Inc. July 1997 - June 2003
Chiron Technologies, Center for Gene Therapy July 1995 - July 1997
Viagene, Inc. May 1989 - July 1995
Skills
Strategic Sourcing, Purchasing, Software Project..., Facilities Management, Contract Management, Project Management, GMP, Biotechnology, Lifesciences, Quality System, FDA, Validation, Sop, Information Technology, Integration, Change Control, Management, IT Management, Quality Assurance, Technology Transfer, 21 CFR Part 11, Manufacturing, CAPA, Pharmaceutical Industry, Computer System..., Cross-functional Team..., Start-ups, GxP, Process Simulation, V&V, Software Documentation, Medical Devices, ISO 13485, Biopharmaceuticals, Quality Control, LIMS, Quality Auditing, GLP, GAMP, Process Improvement, R&D, Regulatory Requirements, Regulatory Affairs, Life Sciences
Education
University of Phoenix 1995 — 1997
BS, Business, Information Systems
Lake Region Medical April 2015 - Present
Validation Technologies, Inc. 2014 - 2015
Massachusetts Eye and Ear Infirmary May 2013 - August 2013
Lehigh University September 2011 - December 2012
Skills
Matlab, Microsoft Excel, Biomedical Engineering, SolidWorks, PowerPoint, C++, Data Analysis, FDA GMP, Product Development, Six Sigma, Market Research, Project Management, Statistics, Microscopy, PCR, Gel Electrophoresis, Science, Biomaterials, Sterilization, Microfluidics, Clinical Research, HIPAA, Molecular Biology, Western Blotting, Stem Cells, Cell Culture, Bioengineering, JavaScript
Education
Lehigh University 2010 — 2014
Bachelor of Science (B.S.), Bioengineering, Minor in Business
Validation Technologies, Inc. August 2014 - Present
Validation Technologies, Inc. April 2012 - August 2014
Validant February 2012 - April 2012
Hyde Engineering + Consulting May 2011 - August 2011
Pall Corporation August 2007 - July 2010
The Validation Company December 2006 - August 2007
Artes Medical February 2005 - August 2005
Biogen Idec August 2004 - December 2004
Skills
Engineering, Process Engineering, Validation, Cross-functional Team..., Manufacturing, Process Simulation, Software Documentation, Sop, V&V, Root Cause Analysis, Change Control, Biotechnology, Project Management, Testing, Chromatography, Technology Transfer, Quality Control, Quality Assurance, Filtration, GMP, Biopharmaceuticals, SOP
Education
University of California, San Diego 1999 — 2006
Bioengineering, Bioengineering & Design
La Jolla High School 1995 — 1999
Diploma, Physics
McGuff Pharmaceuticals May 2014 - Present
Neutrogena September 2011 - December 2013
Olympus Biotech Corporation February 2011 - September 2011
Stryker Biotech August 2010 - January 2011
Validation Technologies, Inc. July 2006 - August 2010
B. Braun Medical December 2004 - June 2006
Skills
Validation, CAPA, cGMP, SOP, 21 CFR Part 11, FDA, GLP, Change Control, Quality Systems, Biotechnology, GxP, Quality Assurance, Root Cause Analysis, CIP, Cleaning Validation, Computer System..., GAMP, Documentation, Technical Writing, Compliance, Risk Assessment, Quality Auditing, Pharmaceutical Industry, Aseptic Processing, Biopharmaceuticals, GMP, V&V, ISO 13485, Sop, Technology Transfer, Quality System, Software Documentation, Medical Devices, Regulatory Requirements, LIMS, Calibration, Regulatory Affairs, Quality Control, FDA GMP, Lifesciences, Chromatography, Microbiology, Vaccines, Sterilization, HPLC, GCP, Process Simulation, Pharmaceutics, Purification, Formulation
Education
University of California, Los Angeles 2001 — 2004
Bachelor of Science, Biology
Histogenics July 2013 - Present
Genzyme January 2013 - July 2013
Validation Technologies, Inc. November 2011 - December 2012
MassBiologics August 2011 - November 2011
Masy Systems, Inc. May 2011 - July 2011
Masy Systems, Inc. July 2008 - January 2011
Skills
cGMP, Validation, GMP, ISO, Excel, Aseptic Technique, Cell Culture, EMT, Microbiology, Aseptic Processing, Microsoft Excel, Quality Control, Laboratory, FDA
Education
Worcester Polytechnic Institute 2007 — 2011
B.S., Biotechnology
Fachhochschule Konstanz - Hochschule für Technik, Wirtschaft und Gestaltung 2009 — 2009
German Language and Literature
Genzyme, a Sanofi company August 2014 - Present
Sanofi Pasteur March 2009 - August 2014
Validation Technologies, Inc. November 2008 - March 2009
Skills
CIP systems, Pharmaceutical Industry, Cleaning Validation, Protein Assays, ELISA, HPLC, OASIS, Documentum, Titration, Filtration, Clean Rooms, Dissolution, Protein Conjugation, Data Entry, Water Sampling, Product Sampling, SIP, Musical Instruments, Delta V, Microsoft Office, Cell Culture, Microbiology, Immunology, Community Outreach, Autoclave, GMP, Sterilization, P&ID, SOP authoring, SWI authoring, Protocol Design, 21 CFR Part 11, CAPA, Aseptic Processing, Aseptic Technique, GLP, Environmental Monitoring, LIMS, GxP, cGMP manufacturing, cGMP practices, Deviations, SOP development, Downstream Processing, Validation, Change Control, Trackwise, Protocol, Drug Safety, CIP
Education
University of Massachusetts, Amherst 2012 — 2015
Master's Degree, Public Health
Northeastern University 2010 — 2011
Regulatory Affairs for Drugs, Biologics and Medical Devices
University of Scranton 2004 — 2008
Bachelor of Science (B.S.), Biology, General
Sanofi Pasteur March 2015 - Present
Intuitive Technology Solutions June 2013 - January 2015
Compli, LLC February 2012 - June 2013
Validation Technologies, Inc. August 2011 - February 2012
Experis September 2010 - August 2011
ManpowerGroup June 2010 - September 2010
Chaperone Technologies, Inc September 2009 - December 2009
Proctor and Gamble June 2002 - September 2003
Skills
Validation, Quality Assurance, GMP, Cleaning Validation, 21 CFR Part 11, CAPA, Vaccines, Manufacturing, Change Control, Technical Writing, Deviations, Pharmaceutical Industry, GLP, LIMS, GAMP, GxP
Education
East Stroudsburg University of Pennsylvania 2005 — 2010
BA, Chemistry
Tunkhannock Area High School
Validation Technologies, Inc. March 2013 - Present
Comcast Cable May 2011 - January 2012
Oceanside Unified School District October 2006 - June 2010
Sharp Mission Park Medical Group March 2000 - August 2003
Skills
Biotechnology, Pharmaceutical Industry, Business Analysis, Sop, Management Consulting, Quality Assurance, FDA
Education
National University 2008 — 2010
Master of Education (MEd), Teaching and Learning in a Global Society
Park University 2004 — 2008
Bachelor's degree, Liberal Arts and Sciences/Liberal Studies
Validation Technologies, Inc. Accounting AssistantJDZ IncApril 2013 - April 2014
Epsilon August 2012 - December 2012
SAIC April 2007 - May 2012
Skills
Accounting, Accounts Payable, Accounts Receivable, Account Reconciliation, Financial Reporting, General Ledger, Financial Accounting, QuickBooks, Microsoft Excel, Financial Analysis, Auditing, Internal Controls, Payroll, Budgets, Bank Reconciliation, Journal Entries, Invoicing, Fixed Assets, Financial Statements, Bookkeeping, Customer Oriented, Contract Closeout
Education
San Diego State University-California State University 1997 — 2003
Bachelor's degree, Accounting
California State University-Sacramento
Hyde Engineering + Consulting September 2011 - Present
PharmaSolutions, Inc. 2002 - Present
Emergent BioSolutions 2009 - August 2011
Biokinetics Inc. 2007 - 2008
Insmed 2004 - 2007
Validation Technologies, Inc. 2003 - 2004
Baxter Hemoglobin Therapeutics 1996 - 2003
Somatogen 1990 - 1996
Skills
GMP, Technology Transfer, Validation, Biotechnology, FDA, Biopharmaceuticals, Pharmaceutical Industry, GLP, CAPA, Lifesciences, Change Control, Quality System, Commissioning and..., Fill and Finish, Isolation Technology, Project Management, Cleaning Validation, Protocol Development, Autoclave Validation, EMEA /EudraLex..., Process Engineering, Process Development, Design of Experiments, Microbiology, Fermentation, V&V, Protocol, Process Simulation, Cell Culture, Manufacturing, Sop, 21 CFR Part 11, Protein Chemistry, Downstream Processing
Education
University of Colorado Boulder 1978 — 1983
Saguaro High School 1974 — 1978
ValSource, LLC October 2014 - Present
Vertex Pharmaceuticals October 2014 - Present
Civitas Therapeutics January 2014 - October 2014
LotusWorks January 2014 - October 2014
Validation Technologies, Inc. May 2012 - January 2014
LabCorp September 2011 - May 2012
Apex Formulations Pvt Ltd August 2008 - July 2009
Lincoln Pharmaceuticals Ltd May 2008 - July 2008
Chandra Agency March 2007 - April 2008
Skills
GMP, Validation, Sop, 21 CFR Part 11, Pharmaceutics, Change Control, Quality Assurance, CAPA, V&V, Cleaning Validation, GLP, FDA, Auditing, LIMS, CIP, SIP, UV/Vis, HPLC, Pharmaceutical Industry, Process Validation, Product Validation, Analytical Techniques, Software Documentation, Wet Chemistry, Qualification Protocol..., Validation..., Root Cause Analysis, Risk Management, Project Management, Computer System..., SOP Writing, Documentation, cGMP, ISO, Lean Manufacturing, Process Manufacturing, NLCP, Pharmaceutical..., Pharmaceutical..., Process Engineering, Regulatory Affairs, Pharmaceuticals, Manufacturing, Calibration, Dissolution, Quality System, Biotechnology, GxP, GAMP, Aseptic Processing
Education
New Jersey Institute of Technology 2009 — 2011
Master of Science, Pharmaceutical Engineering
Gujarat University 2005 — 2009
Bachelors, Pharmacy
Pacira Pharmaceuticals, Inc. November 2014 - Present
Validation Technologies, Inc. August 2013 - May 2014
BioSPEQ January 2011 - October 2012
Teva Pharmaceuticals March 2011 - February 2012
Global Automation Partners April 2005 - July 2010
Genentech April 2005 - July 2010
SNC-Lavalin 1996 - 2000
Skills
Validation, GMP, Pharmaceutical Industry, Computer System..., Automation, FDA, Sop, Biopharmaceuticals, Testing, Budgets, Change Control, Biotechnology, MES, Technology Transfer, MS Project, Troubleshooting, Process Improvement, Quality Assurance, Process Engineering, PowerPoint, Building Management..., HVAC, Regulatory Affairs, Project Management, 21 CFR Part 11, V&V, GAMP, CAPA, Quality System, Instrumentation, Cross-functional Team..., GxP, Root Cause Analysis, Process Control, Process Optimization, Aseptic Processing, Regulatory Requirements, Commissioning, Process Automation, Technical Writing, Project Engineering, Chemical Engineering, Process Simulation, Software Documentation, Process Development, Process Design, Manufacturing, Management, Engineering, Leadership
Education
McGill University 1975 — 1979
Bachelor's degree, Mechanical Engineering
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 Technologies, Inc. January 2012 - Present
Commissioning Agents, Inc CAI Consulting April 2007 - January 2012
ESPN September 2003 - April 2007
US Navy April 1983 - September 2003
US Navy January 2001 - August 2003
US Navy January 1997 - January 2001
US Navy November 1993 - December 1996
US Navy June 1991 - October 1993
US Navy September 1989 - May 1991
US Navy May 1987 - August 1989
Skills
Project Management, Team Leadership, Cross-functional Team..., Client Relations, Budget Management, Budget Forecasts, Project Planning, Project Coordination, Biotechnology..., Pharmaceutical..., Intercultural..., Critical Utilities, Environmental Monitoring, Water for Injection..., Clean Steam Generation..., Automation, Critical gases, Analytical Instruments, Equipment Validation, Cleaning Validation
Education
University of New Haven 2003 — 2005
Master of Business Administration (MBA), Business Administration and Management, General
Charter Oak State College 2001 — 2003
Bachelor of Applied Science (BASc), General Studies
Validation Technologies, Inc. March 2013 - Present
Sovereign Bank September 2012 - December 2012
Citizens Bank April 2012 - June 2012
MRI The Boston Group February 2009 - April 2012
Skills
Permanent Placement, Internet Recruiting, Technical Recruiting, Medical Devices, Screening, Screening Resumes, Candidate Generation, Sourcing, Lifesciences, Engineering, Software Engineering, Boolean Searching, Boolean Logic, Talent Acquisition, Talent Management, Hardware Engineering, Applicant Tracking..., Biotechnology, Biopharmaceuticals, Biologics, Pharmaceutical Industry, FDA GMP, Validation, Quality Assurance, Commissioning, Recruiting, Corporate Recruiting, Full-life Cycle..., Qualifying Candidates, Passive Candidate..., Passive Candidate..., Calibration, cGMP practices, Management, Hiring, Executive Search, Life Sciences
Education
Ithaca College
Bachelor of Science (B.S.)
D & D Consulting LLC June 2008 - Present
Validation Technologies Inc October 2006 - June 2008
ImClone Systems Inc September 2000 - October 2006
Roche Molecular Systems June 1993 - September 2000
Skills
Project Management, FDA, V&V, Validation, GMP, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, SOP, CAPA, Change Control, Technology Transfer
Education
Montclair State University 1988 — 1993
Westfield High School
Bayer HealthCare April 2008 - Present
Validation Technologies, Inc. January 2006 - March 2008
Biogen Idec April 2002 - January 2006
Regeneron Pharmaceuticals August 1996 - April 2002
Skills
Technology Transfer, CAPA, Biopharmaceuticals, V&V, GMP, Process Simulation, FDA, Validation, Biotechnology, Change Control, 21 CFR Part 11, Computer System..., Fermentation, Purification, Manufacturing
Education
University of Rochester 1992 — 1996
Bachelor of Science, Chemical Engineering
SAFC Carlsbad January 2005 - Present
Validation Technologies, Inc. November 2001 - December 2004
Validation Technologies, Inc. August 1997 - October 2001
Skills
Cleaning Validation, Aseptic Processing, CAPA, Validation, GMP, Sop, Change Control, Biopharmaceuticals, Biotechnology, 21 CFR Part 11, Pharmaceutical Industry, Autoclave, Sterilization, CIP, HPLC, Deviations, Clean Rooms, Bioreactor, SOP
Education
USC 1977 — 1980
University of Tehran 1971 — 1975
Perficient, Inc. April 2010 - Present
BioPharm Systems, Inc. January 2013 - April 2014
BioPharm Systems, Inc. April 2010 - December 2012
Amylin Pharmaceuticals May 2007 - April 2010
Validation Technologies, Inc. January 2007 - May 2007
Analyst International August 2005 - February 2007
Jacobs Engineering April 2003 - August 2005
Crew Technical Services August 2000 - April 2003
Skills
Quality Assurance, Quality System, Validation, Pharmaceutical Industry, Medical Devices, 21 CFR Part 11, CAPA, Change Control, GMP, Quality Control, ISO 9001, ICH-GCP, ISO 27001, Computer System..., 21 CFR 820, Software Documentation, ISO 13485
Education
Purdue University 1993 — 1998
B.A., Communications
Associated Staffing January 2013 - Present
Oxford Global Resources September 2012 - December 2012
Insight Global July 2012 - August 2012
Validation Technologies, Inc. May 2012 - July 2012
Enterprise System Partners Limited December 2010 - May 2012
JM Hyde Consulting July 2010 - February 2011
Validation Engineer – Bukovac and Duncan TG 2010 to Present April 2010 - June 2010
Techsource2009 to 2010 December 2009 - January 2010
Commissioning Agents, Inc December 2005 - February 2009
Millennium Validation Services March 2004 - October 2005
Skills
DeltaV, Allen Bradley, Commissioning, CIP, DCS, Wonderware, Start-ups, Biotechnology, ControlLogix, PLC, SCADA, Instrumentation, Change Control, Equipment Qualification, Equipment Commissioning, PI Data Historian, Deviation Investigation, Validation, GMP, V&V, Sop, WebDAV, Quality Assurance, Automation, Quality System, Process Control, Deviations, Pharmaceutical Industry, Control Logic, Engineering, Cleaning Validation, Quality Control, 21 CFR Part 11, Calibration, CAPA, GxP, Testing, FDA
Education
Waukesha County Technical College 1979 — 1981
Associate, Electronics
Community College of Philadelphia
Associate's degree, Engineering Science
NSF Health Sciences June 2013 - Present
Compliance Management Systems, Inc. 2007 - Present
Allergan 2010 - May 2015
Bend Research 2010 - 2010
Dendreon 2009 - 2009
Merck 2008 - 2009
Bayer HealthCare (Berlex Biosciences) 2007 - 2008
Validation Technologies, Inc. 2007 - 2007
Bristol-Myers Squibb, ZymoGenetics 2004 - 2007
Biogen Idec 2001 - 2004
Skills
Salesforce.com..., Salesforce.com GxP..., ISO 9001, FDA, Validation, Quality Auditing, 21 CFR Part 11, GMP, GxP, GLP, Change Control, Quality Assurance, Pharmaceutical Industry, Computer System..., Quality System, Medical Devices, Biotechnology, Regulatory Affairs, SOP, CAPA, Biopharmaceuticals, GCP, GAMP, Software Documentation, ISO 13485, V&V, ISO 14971, Design Control, SharePoint, Life Sciences
Education
University of Toronto - Rotman School of Management
Master of Business Administration
Western University
Bachelor of Engineering Science (BESc)
San Diego State University-California State University
Master of Science, Regulatory Affairs (MSRA)
Validation Technologies, Inc. October 2013 - Present
International Medication Systems, Limited January 2012 - October 2013
International Medication Systems, Limited August 2011 - January 2012
Sierra Summit, UCSD Housing and Dining Services January 2008 - June 2009
Skills
Validation, Data Analysis, Team Leadership, Technical Writing, Microsoft Excel, 21 CFR Part 11, Cleaning Validation, FDA, Time Management, Problem Solving, Microsoft Office, Equipment Qualification, People Skills, GMP, Biochemistry, SharePoint, Equipment Commissioning, GDP, cGMP manufacturing, Visual Inspection, Root Cause Analysis, Project Planning, Conductivity Meter, Quality Assurance, Kaizen, ISOtrain, Multimeter, GSS, ISO, ICH Guidelines, MHRA, ANSI, USP, PDA, GxP, GAMP, Process Validation, Autoclave, Lyophilization, Cross-functional..., Worst Case Analysis, Chemstation, tiamo, Chromeleon, JD Edwards, Consulting, Gas Chromatography, Liquid Chromatography, DMAIC, 5S
Education
University of California, San Diego 2007 — 2011
Bachelor of Science (BS), Biochemistry and Molecular Biology
Chino Hills High School 2003 — 2007
High School Diploma
Community Chiropractic Center May 2015 - June 2015
Validation Technologies, Inc. June 2013 - June 2015
Pier 1 Imports March 2012 - March 2013
Boom Marketing August 2012 - December 2012
Pali Science Camp August 2012 - October 2012
Olios Cafe and Grill October 2011 - January 2012
Base Camp Challenge Center November 2008 - January 2012
Redwood Lodge 2010 - 2011
ABC12 News June 2010 - August 2010
Skills
Customer Service, Sales, Facilitators, Microsoft Office, Rock Climbing, Administrative..., Merchandising, PowerPoint, Data Entry, Event Planning, Collections, Microsoft Word, Time Management, Microsoft Excel, Recruiting, Store Management, Teaching, High Ropes, Retail, Visual Merchandising, Zip Line, Media, Creative Writing, Retail Sales
Education
University of Michigan 2010 — 2011
Bachelor's degree, Communication and Media Studies
Mott Community College 2008 — 2010
Associate's degree, Business/Commerce, General
Thermo Fisher Scientific September 2015 - Present
Talent Management Consulting July 2013 - Present
Furlocity, Inc. March 2012 - February 2015
Validation Technologies, Inc. March 2012 - July 2013
Genoptix a Novartis Company January 2012 - February 2012
Lucas Group January 2011 - November 2011
Kelly Scientific Resources August 2008 - January 2011
K &K International Consulting June 2006 - July 2008
The Scripps Research Institute September 2000 - March 2005
Skills
Talent Management, Recruiting, Business Development, Executive Search, Interviews, Leadership, Biotechnology, Technical Recruiting, Applicant Tracking..., LinkedIn, Talent Acquisition, Human Resources, Entrepreneurship, Start-ups, Pharmaceutical Industry, Pet Industry, LinkedIn Recruiter, LinkedIn Training, Linkedin Marketing, Pets, Management, Sales, New Business Development, Animals, Sourcing, Hiring, FDA, Life Sciences, Program Management, Strategic Recruitment..., Strategic Partnerships, Business Networking, Lifesciences, Process Improvement, Networking, Search, CRM, Employer Branding, Pet Accommodations, Veterinary, Dogs, Full-cycle Recruiting, LinkedIn Optimization
Education
Emory University 1996 — 2000
B.S., Biology, Neuroscience, Primatology
Pine View School for the Gifted 1994 — 1996
High School
Pandora's Box Pictures 2015 - Present
Lionsgate 2015 - 2015
Interscope Records 2015 - 2015
Women In Film 2015 - 2015
Validation Technologies, Inc. June 2014 - August 2014
Skills
Screenwriting, Film Production, Short Films, Feature Films, Directing, Art, Editing, Leadership, Teamwork
Education
John Paul the Great Catholic University 2015 — 2017
Bachelor’s Degree, Screenwriting
Cathedral Catholic High School 2010 — 2014
High School
Validation Technologies, Inc October 2009 - Present
Vaughan Group Ltd September 2006 - September 2007
JLS Properties February 2004 - September 2006
Edward Rose Associates February 1999 - June 2003
Education
Springboro High School
Miami University
Tunnell Consulting, Inc. March 2015 - July 2015
ALKU Technologies November 2014 - January 2015
Validation Technologies, Inc. March 2014 - September 2014
Validant April 2013 - January 2014
ProPharma Group February 2012 - March 2013
Pharmceutical Validation Solutions December 2007 - April 2012
Amgen January 2006 - October 2007
VaxGen June 2005 - November 2005
Boston Scientific, MN November 2004 - June 2005
various Ambulance Services June 1993 - August 2004
Skills
Cleaning Validation, Validation, Commissioning, Project Management, Technical Writing, Quality Assurance, Consent Decree..., Consent Decree, FDA, Change Control, V&V, Sop, GAMP, GLP, Aseptic Processing, Trackwise, GMP, CAPA, Computer System..., GxP, 21 CFR Part 11, Medical Devices, Biotechnology, Quality System
Education
Three Rivers Community College 1995 — 1996
Englewood Sr High School 1983 — 1986
HS Diploma
DSM November 2012 - Present
DSM August 2010 - November 2012
Validation Technologies, Inc. March 2010 - August 2010
Sanofi Pasteur, Inc March 2010 - August 2010
2009 Stevens Institute of Technology August 2005 - May 2009
JARCHEM Industries May 2008 - August 2008
BP January 2007 - June 2007
Colgate Palmolive January 2006 - August 2006
Skills
Quality Assurance, Validation, Training, GMP
Education
Stevens Institute of Technology 2009 — 2011
Masters of Science, General Management
Stevens Institute of Technology 2004 — 2009
2011Masters of Science; Bachelor of Engineering, Management; Chemical Engineering
Validation Technologies, Inc. July 2013 - Present
The Sporting Club May 2012 - July 2013
Corporate Alliance January 2013 - April 2013
NCAA UCSD Women's Tennis Team September 2009 - April 2013
UC San Diego June 2012 - December 2012
UCSD Tennis Camps June 2011 - August 2011
Skills
Social Networking, Public Speaking, Microsoft Office, Customer Service, Event Planning, PowerPoint, Microsoft Excel, Social Media, Microsoft Word, Visio, Primavera P6, Delta V, Data Analysis, Sales, Leadership, Research, Project Management, Event Management, Marketing, Fundraising, Social Media Marketing, Time Management, Team Leadership, Facebook
Education
University of California, San Diego 2009 — 2013
Bachelor of Science (B.S.), Cognitive Neuroscience
Sanofi Pasteur December 2010 - Present
Sanofi Pasteur Limited July 2006 - January 2011
Sanofi Pasteur Limited May 2001 - June 2006
Seneca College September 1995 - December 2005
Novartis Pharmaceuticals Canada Inc June 1997 - May 2001
Validation Technologies Inc July 1995 - June 1997
Genpharm Inc August 1994 - July 1995
CIBA Vision Sterile Manufacturing October 1989 - August 1994
X-Ray Assay Labs Ltd September 1987 - July 1989
Skills
GMP, Validation, CAPA, FDA, Quality Assurance, Change Control, V&V, Quality Control, SOP, Pharmaceutical Industry, GxP, 21 CFR Part 11, Quality Auditing, Cleaning Validation, Quality System, Regulatory Affairs, GLP, Aseptic Processing, Computer System..., LIMS, Regulatory Requirements, Calibration, R&D, Sterilization, Medical Devices, Software Documentation, Analytical Chemistry, Technology Transfer, Training, Manufacturing, Laboratory, Document Management, Technical Writing, Deviations, Biopharmaceuticals, GAMP, Quality Management, Vaccines, Testing, Auditing, Biotechnology, Quality System..., Lifesciences, Root Cause Analysis, Process Validation, GCP, cGMP, Quality Systems, Equipment & Utilities..., HOPE
Education
RAPS Online University
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Seneca College of Applied Arts and Technology
Recognition of Achievement, Excellence in Educating Adults
Pharmaceutical Sciences Group
Certificate, Level I
Centennial College
Certificate, Computer Graphics and Desktop Publishing
Centennial College
Certificate, Quality Assurance
International Correspondence Schools
Diploma, Computer Programming in Basic
University of Toronto
B.Sc, Chemistry Major
International Career School Canada
Diploma, Freelance Writer
AES (Automation Engineering Systems, Inc.) March 2015 - Present
Validation Technologies, Inc. 2013 - 2015
Watertown Department of Public Health 2009 - 2009
Skills
Chemical Engineering, Process Engineering, Validation, Engineering, Microsoft Office, Process Control, MathCAD, Matlab, Thermodynamics, Chemistry, Manufacturing, Materials Science, GMP, Labview, Environmental Monitoring, Nanotechnology, Temperature Mapping, Technical Documentation, Automation, Qualification..., Change Management, TrackWise, SOP Development, Document Review, Microsoft Project
Education
University of Massachusetts, Amherst 2008 — 2013
Bachelor of Science (BS), Chemical Engineering
Air Liquide America 2008 - Present
Validation Technologies, Inc. 2006 - 2008
Air Products 2000 - 2006
Rohm and Haas 1997 - 2000
Education
Rochester Institute of Technology 1991 — 1995
Bachelor's degree, Biology, General
Baxalta January 2003 - Present
Baxter BioScience January 2003 - June 2015
Validation Technologies, Inc. 2002 - 2002
Amgen 2001 - 2002
Alpha Therapeutic 1999 - 2000
GE Marquette Medical Systems December 1997 - 1999
Education
California State University-Long Beach - College of Business Administration 1993 — 1996
MBA, Information Management
California State University-Long Beach 1986 — 1989
BS, Electrical Engineering
Baxalta February 2014 - Present
Validation Technologies, Inc. November 2011 - December 2013
Merck Sharp & Dohme October 2010 - October 2011
Validation Technologies Inc June 2007 - October 2010
Allergan March 2006 - June 2007
Wyeth Biotech December 2004 - March 2006
Skills
21 CFR Part 11, Computer System..., GAMP, Change Control, Cleaning Validation, Validation, Biotechnology, GxP, V&V, GMP, CAPA, Sterilization, FDA, Sop, FDA GMP, GLP, Aseptic Processing, Quality Control, Biopharmaceuticals, ISO 13485, LIMS, Technology Transfer, Pharmaceutics, Pharmaceutical Industry, Quality Assurance, Analytical Chemistry, Quality System, Vaccines, Trackwise, Regulatory Requirements, Quality Auditing, Process Simulation, HPLC, SOP, TrackWise
Education
New Jersey Institute of Technology 2004 — 2006
Graduate, Chemical Engineering
Punjab Technical University 1999 — 2003
Undergraduate, Chemical Engineering
Validation Technologies, Inc. June 2015 - Present
Gilead Sciences December 2012 - May 2015
Gilead Sciences January 2008 - December 2012
Johnson & Johnson Pharmaceutical Research and Development April 2006 - December 2007
Scios Inc. October 2002 - April 2006
COR Therapeutics Inc. March 1998 - March 2002
Chiron Corp. November 1995 - March 1998
Syntex July 1991 - June 1995
UC Davis School of Medicine October 1990 - June 1991
Skills
21 CFR Part 11, Analytical Chemistry, Biopharmaceuticals, Biotechnology, CAPA, Computer System..., Cross-functional Team..., FDA, GxP, GMP, Manufacturing, LIMS, Medical Devices, Pharmaceutical Industry, Quality Assurance, Quality Control, Quality System, SOP, Sop, V, Validation
Education
University of California, Davis 1987 — 1991
B.S.
Home January 2015 - Present
Allergan December 2009 - December 2014
Validation Technologies, Inc. April 2001 - December 2014
Amylin Pharmaceuticals 2009 - 2009
Allergan 2005 - 2008
B Braun McGaw 1994 - 2000
Skills
Computer System..., Manufacturing, R&D, Software Documentation, GxP, Project Management, Medical Devices, Lean Manufacturing, Quality Assurance, Product Development, Quality System, Sop, Change Control, FDA, GMP, Pharmaceutical Industry, Continuous Improvement, Troubleshooting, CAPA, Root Cause Analysis, 21 CFR Part 11, ISO 13485
Education
San Diego State University-California State University 1975 — 1977
BSME
MS9 Consulting Validation Team LeadNovartis V&D IT, Emeryville,CA2006 - 2008
Validation Technologies, Inc August 2003 - November 2004
Exxon Mobil 1981 - 1990
Education
Massachusetts Institute of Technology 1972 — 1976
Columbia University in the City of New York 1970 — 1972
BS, Chemical Engineering
Validation Technologies, Inc. August 2015 - Present
N/A - Independent Contractor April 2010 - August 2015
Pharmalucence 2011 - 2012
Shire HGT 2010 - 2010
Shire HGT 2010 - 2010
Valsource August 2002 - September 2009
Valsource August 2002 - September 2009
Lonza 2008 - 2009
Regeneron Pharmaceuticals, Inc. 2007 - 2009
Regeneron Pharmaceuticals, Inc. 2007 - 2009
Skills
GMP, CAPA, Computer System..., V&V, FDA, Change Control, 21 CFR Part 11, Cleaning Validation, Biotechnology, Pharmaceutical Industry, GxP, Aseptic Processing, Quality System, Technology Transfer, Biopharmaceuticals, Sop, GAMP, Regulatory Affairs, Process Simulation, Validation, SOP
Education
Northeastern University 1989 — 1994
BS, chemical engineering
Number 2 High School Attached to East China Normal University
brookline high school
Sanofi Pasteur January 2013 - Present
Sanofi Pasteur January 2007 - April 2013
Validation Technologies Inc. 2007 - 2008
ImClone Systems 2004 - 2007
Lockwood Greene 2001 - 2002
Skills
V&V, Cleaning Validation, Validation, GMP, Aseptic Processing, 21 CFR Part 11, GAMP, Change Control, CAPA, FDA, Sop
Education
Stevens Institute of Technology 1993 — 2007
masters, pharmaceutical manufacturing
GE Aviation November 2011 - Present
Validation Technologies, Inc January 2000 - November 2011
Education
University of New Hampshire 1985 — 1990
Salem High School
American Astronautical Society January 2007 - Present
Validation Technologies, Inc. March 2014 - March 2015
Marcus Family Law Center, PLC January 2009 - September 2013
The Coast News Group July 2007 - July 2009
Marcus Tutoring Company January 2004 - June 2007
Revlon April 1998 - August 2000
Medtronic; Hewlett-Packard; Brobeck, Phleger and Harrison, LLC; January 1994 - March 1998
Skills
Public Relations, Management, Research, Japanese, Project Management, Financial Reporting, Human Resources, Accounting, Financial Analysis, Operations Management, Editing, Journalism, Blogging, Publishing, Family Law, Microsoft Excel, HTML, Network Administration, Computers, Program Management, Academic Tutoring, Training, QuickBooks, Paralegals, PHP, Projector, Law Clerk, Mediation, Managerial Finance, Financial Controlling, Calculus, AP Style, Ordinary Differential..., Classical Mechanics, Strategy, Leadership, Marketing
Education
UCSD 2003 — 2007
Bachelor of Arts (B.A.), Japanese Studies
Palomar College 2001 — 2003
Associate of Arts and Sciences (A.A.S.), Music, Mathematics
Boehringer Ingelheim February 2015 - Present
McNeil Consumer Healthcare June 2013 - October 2014
Neutrogena August 2011 - June 2013
Teva Pharmaceuticals October 2010 - September 2011
Validation Technologies Inc. July 2008 - August 2010
Hyde Engineering + Consulting May 2005 - June 2008
Skills
GMP, Cleaning Validation, Validation, GLP, Deviations, FDA, CAPA, Sop, Biotechnology, Pharmaceutical Industry, Computer System..., GxP, Technical Writing, Change Control, 21 CFR Part 11, V&V, Aseptic Processing, ISO 13485, Quality Assurance, Vaccines, HPLC, Microbiology, Technology Transfer, SOP, Biopharmaceuticals, Cross-functional Team..., FDA GMP, Process Validation
Education
Northeastern University 1998 — 2001
B.S., Chemistry
Pharmalucence September 2014 - Present
Pharmalucence November 2011 - September 2014
Pall Corporation May 2011 - November 2011
Validation Technologies Inc October 2008 - October 2011
Biometrix Corp August 2007 - October 2008
Biometrix Corp December 2005 - August 2007
Hologic, Inc September 1998 - July 2001
Skills
Validation, Calibration, FDA, Sop, Quality System, V&V, Instrumentation, GLP, 21 CFR Part 11, Testing, Biotechnology, Pharmaceutical Industry, Medical Devices, CAPA, R&D, SOP
Education
University of Massachusetts Lowell 2001 — 2005
BSEE, Electrical Engineering
THE PETERSON SCHOOL 1999 — 1999
Certificate, Electronics and PC repair
Validation Technologies, Inc. April 2014 - Present
Merck Sharp & Dohme June 2010 - April 2014
Austin Medical Associates October 2009 - June 2010
Centocor June 2009 - August 2009
Emerson Process Management May 2007 - May 2008
Skills
Project Management, Technical Writing, Emerson DeltaV, PLC Programming, Change Control, Automation, Computer System..., Process Automation, Six Sigma, Process Control, Vaccines, GMP, SDLC
Education
The University of Texas at Austin 2005 — 2010
B. S. Biomedical Engineering
ProPharma Group October 2013 - Present
Pacira Pharmaceuticals, Inc. April 2013 - October 2013
Validation Technologies, Inc. August 2005 - April 2013
Validation Technologies, Inc. August 2005 - April 2013
Skills
Validation, GMP, FDA, Quality System, Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, Medical Devices, Sop, Quality Assurance, Technology Transfer, V&V, Change Control, CAPA, Project Management, Manufacturing, Lifesciences, Customer Service, Sales, Troubleshooting, Microsoft Word, Engineering, Microsoft Office, PowerPoint, Microsoft Excel
Education
California State University-San Marcos - College of Business Administration 2006 — 2008
B.A. Business Marketing, Management, Global Marketing
Validation Technologies Inc July 2008 - January 2009
Validation Technologies inc May 2008 - July 2008
Validation Technologies Inc November 2007 - May 2008
Amgen Inc June 2007 - September 2007
Watson Laboratories, Corona, CA January 2007 - June 2007
Baxter Bioscience April 2005 - October 2006
Viral Genetics February 2005 - April 2005
Skills
21 CFR Part 11, Validation, Sop, V&V, Change Control
Education
California State University
2003 BA, Biology
California State University-Northridge
Pharma-BioServ April 2007 - January 2014
Validation Technologies, Inc. 2006 - 2007
Validation Masters/hitachi 2005 - 2006
Integrated Validation Services 2001 - 2005
Skills
Validation, Cleaning Validation, V&V, Change Control, CAPA, Computer System..., GxP, Sterilization, Vaccines, GMP, FDA, 21 CFR Part 11, Sop, Aseptic Processing, GAMP
Education
University of Pennsylvania 1979 — 1983
BSChE, Chemical Engineering
Kremers Urban Pharmaceuticals March 2014 - Present
Validation Technologies, Inc. August 2013 - March 2014
Cook Pharmica February 2012 - August 2013
ProPharma Group January 2011 - February 2012
Commissioning Agents, Inc October 2007 - January 2011
GKM-Global Knowledge Management April 2006 - September 2007
US Navy November 1985 - November 2005
Skills
Validation, GMP, FDA, Change Control, CAPA, V&V, GAMP, Sop, Biopharmaceuticals, 21 CFR Part 11, GxP, Quality System, Computer System..., Aseptic Processing, Quality Assurance, SOP
Education
Thomas Edison State College 2001 — 2005
Bachelor of Science (BS) Applied Science and Technology, Nuclear Engineering
PAREXEL July 2012 - Present
Eli Lilly and Company September 2003 - July 2012
Eli Lilly and Company September 1998 - August 2003
Validation Technologies, Inc. January 1997 - May 1998
Confab Laboratories February 1995 - December 1996
Health Canada March 1990 - December 1994
Skills
GMP, CAPA, Computer System..., Validation, FDA, Change Control, GxP, LIMS, Pharmaceutical Industry, Quality Assurance, Quality Control, Quality System, Sop, Technology Transfer, Cleaning Validation, SOP
Education
Université de Montréal 1980 — 1983
B.Sc., Biochemistry
JHP February 2011 - Present
Validation Technologies, Inc. July 2008 - December 2010
Amylin Pharmaceuticals July 2008 - November 2010
Boston Scientific 2007 - 2007
Skills
Validation, GMP, Software Documentation, Engineering
Education
Michigan State University 2003 — 2008
B.S, Biosystems-Biomedical Engineering
Coastal Validation Incorporated September 2007 - Present
Validation Technologies, Inc. March 2005 - July 2007
Skills
Change Control, Biotechnology, FDA, Project Management, V
Education
University of Rhode Island 1998 — 2002
Validation Technologies, Inc. November 2013 - Present
SeraCare Life Sciences March 2013 - October 2013
Pfizer January 2012 - March 2013
EMD Serono July 2011 - January 2012
Department of Biology, Northeastern University January 2010 - June 2011
Student Online Services, Northeastern University August 2010 - May 2011
Boichemichal Toxicology Lab, Northeastern University January 2010 - May 2010
Tripda Pharmaceuticals Pvt limited, Gujarat, India June 2009 - December 2009
Skills
HPLC, Chromatography, Protein Chemistry, SDS-PAGE, Cell Culture, Affinity Chromatography, ELISA, Protein Purification, Biotechnology, Assay Development, FPLC, Analytical Chemistry, Monoclonal Antibodies, Filtration, Cell, UV Spectroscpy, Ion Exchange, Mass Spectrometry, SDS PAGE, Characterization, SEC, Capillary..., IEX, Validation, V&V, CAPA, GLP, Aseptic Technique, HIC Chromatography, TFF System, Protein Assay, Process Development, GMP, 21 CFR Part 11, Change Control, Quality Assurance
Education
Northeastern University 2009 — 2011
Master's degree, Biotechnology
LMCP 2005 — 2009
Bachelor's degree, Pharmacy
Intuitive Technology Solutions November 2013 - Present
Validation Technologies, Inc. December 2012 - November 2013
Validation Technologies, Inc. July 2011 - December 2012
Sanofi Pasteur August 2010 - July 2011
Sanofi Pasteur August 2009 - August 2010
Skills
GMP, Sop, CAPA, 21 CFR Part 11, Validation, Aseptic Processing, Cleaning Validation, Change Control, GxP
Education
University of Scranton
Bachelor of Science, Biology
Azzur Group April 2015 - Present
Validation Technologies, Inc. July 2008 - January 2015
USDM September 2010 - February 2011
Skills
Cleaning Validation, Validation, Autoclave, LIMS, Pharmaceutical Industry, 21 CFR Part 11, V&V, Aseptic Processing, CAPA, GAMP, Computer System..., SOP, FDA, CIP, Change Control, Trackwise, GMP, Manufacturing, GxP, GLP
Education
California Polytechnic State University-San Luis Obispo
Validation Technologies, Inc. April 2012 - Present
N/A November 2011 - March 2012
Dendreon April 2011 - November 2011
ValSource, LLC January 2009 - April 2011
N/A January 2008 - December 2008
cGMP Validation LLC December 2003 - December 2007
Skills
Change Control, FDA, Biopharmaceuticals, GAMP, Validation, 21 CFR Part 11, GMP
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor's degree
Charles River Laboratories February 2015 - Present
Charles River Laboratories September 2013 - February 2015
Charles River Laboratories March 2012 - September 2013
Charles River Laboratories March 2010 - March 2012
Charles River Laboratories June 2009 - March 2010
MedImmune February 2009 - June 2009
Validation Technologies Inc. September 2008 - February 2009
Skills
Quality Assurance, Testing, Environmental Monitoring, Microbiology, Manufacturing, Clean Rooms, GMP, FDA, Laboratory, 21 CFR Part 11, Protocol
Education
Northeastern University 2010 — 2012
Graduate Certificate, Biopharmaceutical Domestic Regulatory Affairs
Penn State University 2004 — 2008
Bachelor of Science (B.S.), Life Sciences