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CSV Lead

Job in South Plainfield, Middlesex County, New Jersey, 07080, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2026-02-07
Job specializations:
  • IT/Tech
Job Description & How to Apply Below

Join to apply for the CSV Lead role at Katalyst CRO
.

  • Lead end-to-end Computer System Validation for GxP systems.
  • Develop and review URS, risk assessments, IQ/OQ/PQ protocols, and validation reports.
  • Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GxP.
  • Manage validation risk and maintain systems in a validated state.
  • Collaborate with IT, QA, Labs, and vendors.
Seniority level
  • Mid-Senior level
Employment type
  • Contract
Job function
  • Other
Industries
  • Pharmaceutical Manufacturing
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