CQV Ingenieur / Qualifizierungs- und Validierungsspezialist 80-100% (m/w/d)
Core
Responsible for qualification and validation of process engineering equipment and facilities, ensuring compliance and optimizing processes.
Role type
CQV Engineer (Qualification, Validation, and Verification)
Builds
Process engineering equipment and facilities for Life Sciences manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing / Process Engineering
Required skills
Process engineering equipment qualification, GxP compliance, Technical Change Request (TCR) management, CAPA implementation, Audit support, Decommissioning management, Subject Matter Expert (SME) guidance
Preferred skills
COMOS (Plant Engineering Software), DMS, TrackWise, SAP, Experience with cold storage and cleanrooms
Technologies
COMOS, DMS, TrackWise, SAP, Microsoft Office
Responsibilities
Plan, coordinate, and execute initial and re-qualification of equipment and systems; Evaluate technical changes for qualification needs; Create and maintain CQV and GMP documentation; Act as SME for CQV topics; Support internal and external audits; Conduct periodic reviews and ensure continuous compliance
Seniority
Mid-Senior, hands-on IC