Engineer, Computer Software Assurance

Lead, develop, and execute comprehensive Computer System Validation (CSV) strategies, plans, and protocols (IQ/OQ/PQ) in compliance with FDA and global regulatory requirements. Oversee validation activities for GxP-regulated computerized systems including , manufacturing equipment software, data integrity systems, and custom applications. Ensure systems meet 21 CFR Part 820, 21 CFR Part 11, and ISO 13485 requirements for software validation and electronic records/electronic signatures. Partner with cross-functional teams (Quality, IT, Engineering, R&D, Manufacturing) to ensure compliant system lifecycle management aligned with GAMP 5 guidelines. Drive validation documentation creation, review, and approval, ensuring traceability and regulatory readiness. Ensure systems used in support of G