cGMP CSV Specialist — Hybrid (Oracle Cloud)

Posted 2 days ago

hrsmartFairfax (VA)

SENIORITY

Lead

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About the role

SPN Solutions in Fairfax, VA is seeking a cGMP Computer System Validation Specialist to maintain validated state for ERP systems and cloud migrations under 21 CFR Part 11. You will lead validation plans, IQ/OQ/PQ, assess changes, support inspections, and collaborate with QA, DBAs, and release teams. Requires 5+ years of CSV in FDA-regulated environments, precise writing, US citizenship, and the ability to obtain HHS Tier 2 public trust.

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