We are seeking a Commissioning & Qualification (C&Q) Engineer with strong experience in pharmaceutical process equipment. You will support equipment installation, commissioning, and GMP qualification activities across pharmaceutical and biotech manufacturing sites in Germany.
Key Responsibilities
- Execute commissioning, IQ/OQ/PQ qualification for pharmaceutical process equipment (e.g., bioreactors, mixers, CIP/SIP systems, filtration systems, filling/packaging equipment).
- Prepare and review C&Q documentation: protocols, test plans, reports, risk assessments.
- Support FAT/SAT, equipment start-up, troubleshooting, and performance verification.
- Ensure full compliance with EU GMP, Annex 15, GAMP 5, and internal quality standards.
- Collaborate with engineering, QA, and suppliers to meet project deadlines and quality expectations.
Requirements
- Degree in Engineering (Mechanical, Chemical, Bioprocess, or related).
- Experience in pharma/biotech equipment C&Q is essential.
- Strong understanding of GMP and validation principles.
- Fluency in German (C1 or native); English preferred.
- Ability to interpret P&IDs, URS/FS/DS, and equipment documentation.
- Willingness to work onsite in Germany.
Darwin Recruitment is acting as an Employment Business in relation to this vacancy.
Greg King