Validation Engineer #JN -062021-65179

Thousand Oaks, California
Industry: Mechanical / Manufacture / Electrical Engineers
Job Number: JN -062021-65179

Top 3 Must Have Skill Sets:

  • Experience drafting quality documentation and validating analytical laboratory instrumentation (i.e. HPLC, Spectrophotometer, Karl Fisher Titrator, ECHO etc.)
  • Knowledge of cGMPs and data integrity requirements (21 CFR Part 210/211, Part 11) and analytical instrument qualification (USP 1058).
  • Perform gap assessments on software permissions/configurations for analytical instruments

 Job Description:

  • Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries.
  • Implement 21 CFR Part 11 for new and existing computerized analytical instruments, perform gap assessments and define resolutions in compliance with cGMP requirements.
  • Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.

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