Computer System Validation Engineer

Summary

Support Computer System Validation (CSV) activities for GxP-regulated pharmaceutical and medical device systems, including validation planning, test execution, documentation, and compliance verification against FDA regulations and 21 CFR Part 11. Execute validation test scripts, document results and deviations, conduct impact and risk assessments, and collaborate with cross-functional teams to ensure systems meet regulatory and data integrity requirements. Maintain validation records, support change control and CAPA activities, and identify compliance gaps in regulated computerized environments.