Computer System Validation Expert | Computer System Validation Expert (all gender)

Job Summary

This expert role focuses on ensuring regulatory compliance for computerized systems within the pharmaceutical industry. Day-to-day responsibilities include planning, executing, and documenting validation activities strictly following GAMP 5 and FDA 21 CFR Part 11 guidelines. The expert will maintain GxP and GMP compliance throughout the entire system lifecycle, collaborate closely with IT, QA, and specialized departments, and derive appropriate validation strategies from risk analyses. A key component of the job involves supporting audits and inspections (e.g., by FDA or EMA) and training users and project teams on Computerized System Validation (CSV) topics. Candidates must possess a degree in Informatics, Engineering, or Pharmacy, relevant experience in CSV within the pharmaceutical sector, and deep knowledge of regulatory frameworks like GAMP 5 and 21 CFR Part 11. Fluency in both German and English is required.