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CSV Validation Lead: GxP & FDA Compliance

Job in South Plainfield, Middlesex County, New Jersey, 07080, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2026-02-16
Job specializations:
  • IT/Tech
    IT Consultant, IT Business Analyst
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below
A leading CRO in the pharmaceutical sector is seeking a CSV Lead to manage the end-to-end Computer System Validation for GxP systems. This role involves developing and reviewing URS, risk assessments, and ensuring compliance with FDA regulations. The ideal candidate will collaborate closely with IT, QA, Labs, and vendors to maintain systems in a validated state. Aiming for a mid-senior level candidate, this position offers unique challenges in a dynamic environment.
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