IT System and Validation Analyst

Role: IT System and Validation Analyst overseeing QA for GxP computerized system validation in a regulated biopharma environment. Responsibilities: collaborate with system owners to ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA guidance; provide validation expertise across departments; lead lifecycle activities for system implementations, upgrades, and decommissioning; author and review validation documents; manage system inventories and change controls; support audits and inspections; mentor teams on validation standards. Requirements: Bachelor's in Engineering, Life Sciences, or Computer Science; 5-7+ years of direct CSV experience in FDA/GxP settings; strong knowledge of GAMP 5, regulatory standards, risk-based validation, data integrity, and security; excellent technical writing and cross-functional collaboration skills. Preferred: master's degree. High-Value: validation of GxP systems in manufacturing, quality, or laboratory environments; cloud/SaaS solutions; supporting regulated audits. WorkSetup: not specified; travel not indicated.