23 days old

Validation Engineer/Specialist

Gabe, Inc.®
Thousand Oaks, California 91320
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift, Overtime

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.

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.


Requirements

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).

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.

Categories

Posted: 2020-03-04 Expires: 2020-04-03

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Validation Engineer/Specialist

Gabe, Inc.®
Thousand Oaks, California 91320

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