GMP Validation and Qualification Expert | GMP Validation and Qualification Expert (alle Geschlechter)

Job Summary

Bayer is seeking a dedicated GMP Validation and Qualification Expert to lead and execute critical validation and qualification activities at the PSDC Darmstadt site. This role involves independently managing validation projects, including planning, execution, and timely completion of reports and plans. A core responsibility is conducting Computerized System Validation (CSV) and ensuring data integrity within production, including documentation creation. The expert will also lead and coordinate product and process optimization projects via CAPA or Change measures, acting as a project leader in cross-functional teams for internal, external, and transfer projects. Success in this role requires a strong background in cGMP regulations, process technology, and pharmaceutical production operations, coupled with excellent communication and organizational skills to ensure GMP compliance and participate as a Subject Matter Expert (SME) in inspections. This is an excellent opportunity for a professional with a scientific or engineering background looking to make a significant impact in pharmaceutical manufacturing compliance.