Justin Dubinsky

Justin Dubinsky Email and Phone Number

Data Integrity and Validation Professional @ Global Compliance Partners
Justin Dubinsky's Location
Seattle, Washington, United States, United States
Justin Dubinsky's Contact Details

Justin Dubinsky personal email

n/a

Justin Dubinsky phone numbers

About Justin Dubinsky

Biotech/Pharmaceutical/Medical Device professional specializing in commissioning, qualification and validation (CQV). Experience working individually and in cross-functional teams for companies ranging from startups to multi-billion dollar operations. Provided quality, validation and engineering support for greenfield (new facility), 483/remediation, consent-decree projects. Working knowledge of GxPs and applicable FDA/EU regulations including but not limited to: 21 CFR Part 11, 210, 211, 820 and EU Annex 11. Data Integrity Implementation and Remediation - Gap analysis/remediation, configuration, life cycle document developmentCommissioning/Qualification/Validation: Document generation and executionComputer Software Validation: Quality Management Systems (QMS), Building Management Systems, Environmental Monitoring Systems, Laboratory SystemsTemperature Mapping: Proficient in the use of the Kaye Validator 2000 and various data loggers.Automated Process Equipment: Chemical Reactor, Bioreactor, Homogenizer, Centrifuge, Dryer, FermentorClean Utilities: Clean Steam, RODI Water, Water for Injection, Process Gases, Air Handling UnitsClean Room Qualification: Architectural commissioning, Viable/Non-viable/Surface Bioburden sampling plans.Controlled Temperature Units (CTUs): Freezers, Incubators, Refrigerators, Ovens, Warehouses, etcSterilization: Autoclaves, SIP (Steam in Place)Cleaning Validation: Cycle development, Riboflavin Testing, rinse sampling

Justin Dubinsky's Current Company Details
Global Compliance Partners

Global Compliance Partners

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Data Integrity and Validation Professional
Justin Dubinsky Work Experience Details
  • Global Compliance Partners
    Vice President
    Global Compliance Partners Jan 2024 - Present
    San Francisco , California, Us
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  • Global Compliance Partners
    Sr. Consultant
    Global Compliance Partners Jul 2019 - Present
    San Francisco , California, Us
    View
  • Just - Evotec Biologics
    Csv Lead
    Just - Evotec Biologics Feb 2022 - Present
    Seattle, Wa, Us
    View
  • Assurea Llc
    Member Of The Board Of Advisors
    Assurea Llc Jun 2020 - Present
    Raleigh, Nc, Us
    View
  • Bristol Myers Squibb
    Consultant - Data Integrity And Computer System Validation
    Bristol Myers Squibb Jul 2019 - Feb 2022
    Lawrence Township, Nj, Us
    View
  • Pfizer
    Validation Consultant/Project Lead
    Pfizer Jan 2018 - Jul 2019
    New York, New York, Us
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  • Propharma Group
    Consultant
    Propharma Group Aug 2017 - Jul 2019
    Raleigh, North Carolina, Us
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  • Lonza
    Validation Consultant
    Lonza Aug 2017 - Dec 2017
    Basel, Ch
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  • Sanofi Genzyme
    Validation Engineer - Contractor
    Sanofi Genzyme Nov 2015 - Jul 2017
    Paris, France, Fr
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  • Vti Life Sciences
    Validation Engineer
    Vti Life Sciences May 2015 - Jul 2017
    San Diego, California, Us
    Working as a validation engineer to provide a variety of CQV services to clients. Services include generation of commissioning documents, IQ/OQ/PQ document generation/execution, deviation analysis/corrective action, final report generation, etc.
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  • Xencor
    Validation Engineer - Contractor
    Xencor Aug 2016 - Nov 2016
    Pasadena, California, Us
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  • Keralink International
    Validation Engineer - Contractor
    Keralink International Sep 2016 - Oct 2016
    Baltimore, Maryland, Us
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  • Sci Pharmtech Inc.
    Validation Engineer - Contractor
    Sci Pharmtech Inc. May 2015 - Nov 2015
  • Lsne Contract Manufacturing
    Validation Engineer - Contractor
    Lsne Contract Manufacturing Jun 2015 - Aug 2015
    Bedford, New Hampshire, Us
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  • Phillips Oral Healthcare Inc
    Validation Engineer - Contractor
    Phillips Oral Healthcare Inc May 2015 - Jun 2015
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  • Psc Biotech
    Validation Engineer
    Psc Biotech Apr 2014 - Jun 2015
    Pomona, Ca, Us
    Worked as validation engineer with PSC Biotech to provide CQV services to clients. Also performed software validation activities on ACE (Adaptive Compliance Engine), PSC Software's Quality Management System. Worked as a validation consultant with Bristol Myers Squibb and Phillips Oral Healthcare. See projects for more detail.
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  • Bristol-Myers Squibb
    Validation Engineer - Contractor
    Bristol-Myers Squibb Jan 2014 - Apr 2015
    Lawrence Township, Nj, Us
    View
  • University Of Washington - School Of Medicine
    Laboratory Technician
    University Of Washington - School Of Medicine Sep 2012 - Jan 2014
    Seattle, Wa, Us
    View

Justin Dubinsky Skills

Validation Research Engineering Microsoft Office Pharmaceutical Industry Biotechnology Microsoft Excel Microsoft Word Teamwork Quality System Aseptic Processing Powerpoint Customer Service Gmp Experimentation Java Physics Clean Rooms Compressed Air Steam Water Quality Usp Social Media English Computational Physics Protein Chemistry Fda Simulations 21 Cfr Part 11 Cgmp Practices Cgmp Manufacturing U.s. Food And Drug Administration

Justin Dubinsky Education Details

  • University Of Washington
    University Of Washington
    Engineering Physics/Applied Physics

Frequently Asked Questions about Justin Dubinsky

What company does Justin Dubinsky work for?

Justin Dubinsky works for Global Compliance Partners

What is Justin Dubinsky's role at the current company?

Justin Dubinsky's current role is Data Integrity and Validation Professional.

What is Justin Dubinsky's email address?

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What is Justin Dubinsky's direct phone number?

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What schools did Justin Dubinsky attend?

Justin Dubinsky attended University Of Washington.

What are some of Justin Dubinsky's interests?

Justin Dubinsky has interest in Civil Rights And Social Action, Education, Human Rights, Animal Welfare, Health.

What skills is Justin Dubinsky known for?

Justin Dubinsky has skills like Validation, Research, Engineering, Microsoft Office, Pharmaceutical Industry, Biotechnology, Microsoft Excel, Microsoft Word, Teamwork, Quality System, Aseptic Processing, Powerpoint.

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