Senior CQV Engineer (m/w/d) Life Sciences
Core
Central point of contact for Commissioning, Qualification & Validation (CQV) within Life-Science projects, ensuring pharmaceutical and biotechnological systems are GMP-compliant, tested, documented, and handed over to operators.
Role type
Senior CQV Engineer (Life Sciences)
Builds
Commissioning, qualification, and validation of pharmaceutical and biotechnological plants and utility systems.
Domain
Life Sciences (Pharma, Biopharma, Biotechnology)
Required skills
Commissioning, Qualification & Validation (CQV), URS, FAT, SAT, DQ, IQ, OQ, PQ, GMP requirements, risk-based qualification approaches, regulatory requirements, GEP, ISPE guidelines, process plants, pure steam systems, HVAC, technical utility systems
Preferred skills
Supplier coordination, project team coordination, audit support, development of CQV standards and methods
Technologies
GEP, ISPE guidelines
Responsibilities
Develop and implement risk-based CQV strategies, system boundaries, and qualification/test concepts; Review URS, specifications, and design documents for GMP compliance; Plan and coordinate FAT, SAT, commissioning, and qualification activities; Coordinate with suppliers, specialists, and project teams; Document and track deviations and changes in a GMP-regulated environment; Support audits and inspections.
Seniority
Senior, hands-on IC