Computer Validation Engineer IV

Role: Senior validation specialist overseeing computer system validation for GMP/GLP environments, ensuring compliance with regulations such as 21 CFR Part 11, EU GMP, and GAMP standards throughout the system lifecycle. Responsibilities: coordinate validation and revalidation activities across multiple projects; serve as SME for CSV and quality risk management; develop validation protocols, SOPs, and training; manage incident responses and change controls; collaborate with Quality, Manufacturing, IT, and other departments to maintain validated states of systems including ERP, Veeva, and lab software; evaluate legacy systems for compliance; and support system administration procedures. Qualifications: 8+ years in cGMP/GLP-regulated industries; bachelor's in computer or biological sciences or equivalent; extensive experience with validation of complex computer systems, including network and ERP qualification; familiarity with CFR 21 Part 11, EU GMP Annex 11, and GAMP standards; experience with validation of AI and lab systems preferred. HighValue: validation in biopharma manufacturing and lab settings, regulated environment compliance, cross-functional collaboration, experience with Veeva and ERP systems, and managing multiple validation projects. WorkSetup and travel details are not specified.