732-661-0400

Computer Systems Validation Engineer

  • Location: San Diego
  • Type: Direct Hire
  • Job #34170

CSV Engineer opportunity with our growing biotechnology client in Southern CA! You will be part of a motivated team and work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform CSV activities under the Quality Engineering scope of work.

Daily Responsibilities

  • Ensure compliance of relevant computer systems and applications with regulatory requirements and controls associated with CFR 21 Part 11 and EU GMP Annex 11
  • Development and maintenance of life cycle documents necessary to address the validation lifecycle (Risk assessments, validation plan, SOP, etc.)
  • Participate in site projects and manage all activities in regards to validation and qualification of computer systems and applications
  • Represent CSV implementation during regulatory inspections and partner audits and provide CSV related responses to inspectors/auditors

Who You Are: 

  • Bachelors’ degree in computer science, engineering or science discipline required
  • Minimum of 5 years of hands-on experience in computer system validation or in a quality control analytical laboratory in a GMP/GDP environment required, and in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
  • Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, GAMP, and data integrity standards

INDWST1

 

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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