Computer Systems Validation

This role involves supporting and performing computer systems validation activities within GMP/GxP regulated environments, including the development of scalable validation strategies and documentation. The position requires expertise in FDA 21 CFR Part 11 and experience with enterprise systems like SAP and MES, as well as life sciences systems such as Veeva and Trackwise. Candidates should possess a broad understanding of test management tools and have knowledge of Computer System Assurance (CSA).