Role: C&Q Engineer – CQV for sterile/parenteral manufacturing
Location: Alzey, Germany | Type: Full-time, fixed-term project
Overview:
Support commissioning, qualification, and validation (CQV) for a new high-tech pharmaceutical manufacturing facility. The role covers the full CQV lifecycle from design review and testing to start-up, documentation, and inspection readiness, working cross-functionally with engineering, automation, quality, construction, and operations.
Key tasks:
* Execute CQV for sterile/parenteral systems (formulation, compounding, CIP/SIP).
* Support DQ, risk assessments, FAT/SAT, IOQ/IOV, walkdowns, and system handover.
* Review vendor and installation documentation, close punch lists, and support start-up and inspections.
* Maintain documentation in systems like KNEAT/EIDA and provide project updates.
Requirements:
* Engineering degree + ~5 years CQV experience in GMP pharma/biotech/medtech.
* Experience with sterile/parenteral manufacturing.
* English required (German a plus).
* Knowledge of GMP, EU Annex 1 & 15, ASTM E2500 preferred.
Practical details:
* Start: ASAP (flexible for the right candidate), fulltime
* Remote: generally on-site (exceptions possible)