Cleaning Validation Engineer

2 weeks ago


Swiftwater, United States Stark Associates LLC Full time
Job DescriptionJob DescriptionJob Role: Cleaning Validation Engineer
Location: Swiftwater, PA
Contract: W2

MUST HAVE:

  • Experience in cleaning validation in the biologics or vaccine industry to include the following:
  • Experience in authoring, reviewing, executing and approving validation documents.
  • Interface with Quality organization and the ability to defend rationale in validation documents.
  • Ability to develop cleaning cycle and lead the investigation or trouble shooting.
  • Ability to review and analyze data.
  • Cleaning Validation experience
  • Acceptance criteria determination
  • Sampling plans and sample size determination
  • Rinse and Swab sampling experience
  • Bracketing and worse case rating
  • QC testing requirements
  • Dirty hold times and clean hold times


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