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Validation Engineer/Specialist

Company: Gabriel & Associates
Location: Thousand Oaks
Posted on: March 26, 2020

Job Description:

Gabe, Inc. -- is in need of a Validation Engineer/Specialist with experience in Commissioning, Qualification and Validation of system and hardware components associated with analytical lab instruments.


Education:


  • BS/BA in Information Technology/Computer Science, Biological or Clinical Laboratory or other related discipline or equivalent work experience.


    Experience:

    • 2-5 years of experience with performing validation activities (preferred analytical equipment).
    • Previous experience working in an FDA regulated and/or GMP environment.
    • Working knowledge of Data Integrity principles (CFR Part 11).
    • Strong analytical skills with ability to translate sometimes ambiguous data sets into actionable insights and recommendations.
    • Excellent (written and verbal) communication and interpersonal skills, solid organizational skills, and ability to contribute to a collaborative, flexible work environment.
    • Technical understanding of clinical laboratory operations (desired).


      Responsibilities:

      • Provide leadership and support the development and implementation of EHS Generate and Execute approved protocols/summary reports for commissioning and validation activities.
      • Responsible for test execution, exception reporting, assisting in exception analysis and resolution in a GMP compliant manner.
      • Facilitate and generate Data Integrity assessments.
      • Facilitate and coordinate cross functional team meetings understand client needs and drive action.


        Benefits:

        • Gabe, Inc.-- offers a competitive compensation and benefits package.
        • Position is located at client site in client office/manufacturing space.
        • Normal working hours are 8:00 a.m. to 5:00 p.m. Monday through Friday, however irregular working hours should be expected during project execution.
        • Pay is hourly with overtime and is commensurate with qualifications and experience.


Keywords: Gabriel & Associates, Thousand Oaks , Validation Engineer/Specialist, Engineering , Thousand Oaks, California

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