IT Validation Specialist

Role: IT Validation Analyst supporting GxP-regulated computerized systems within R&D for biopharma operations. Responsibilities: execute and document Computer System Validation (CSV) and Computer Software Assurance (CSA); author validation plans, URS, risk assessments, test scripts, traceability matrices, and validation reports; perform risk-based assessments and coordinate validation testing; manage validation documentation using VLMS, EDMS, and QMS; support Change Controls, Deviations, CAPAs, and audits to maintain compliance. Requirements: Bachelor’s in Life Science, IT, Engineering, or related field; 1-3 years validation experience in biotech/pharma; knowledge of GxP regulations (FDA 21 CFR Part 11, GAMP 5, Data Integrity); experience with validation lifecycle management systems; familiarity with AI validation a plus; strong communication skills. HighValue: supporting validated computerized systems in biotech R&D, including laboratory, quality, manufacturing, and IT systems; experience with validation of AI/ML tools; familiarity with electronic documentation systems. WorkSetup: based in Somerset, NJ, with remote work options; no specific travel mentioned.