CQV Engineer - Pharmaceutical Manufacturing
Contract: 6 months initially | On-site
Start: ASAP / Short notice preferred
Sector: Pharmaceutical Manufacturing / GMP
The Opportunity
We are recruiting an experienced CQV / Qualification Engineer (Qualifizierungsingenieur) to support a pharmaceutical manufacturing project in Munich, Germany.
The assignment focuses on hands-on Commissioning, Qualification & Validation (CQV) activities, particularly the qualification of aseptic filling lines (fill-finish) and associated sterile manufacturing equipment. Qualification Engineers with relevant experience on other GMP manufacturing equipment are also encouraged to apply.
Key Responsibilities
- Execute qualification activities including FAT, SAT, IQ and OQ for pharmaceutical manufacturing equipment.
- Prepare, review and execute qualification protocols, test documentation and reports.
- Perform hands-on equipment testing, troubleshooting and qualification on-site.
- Manage qualification deviations, technical issues and associated documentation.
- Collaborate with Engineering, Manufacturing, QA and equipment suppliers.
- Ensure qualification activities comply with GMP requirements and site procedures.
Experience Required
- Practical CQV, equipment qualification or validation experience within pharmaceutical or biopharmaceutical manufacturing.
- Hands-on experience executing FAT, SAT, IQ and/or OQ activities.
- Strong understanding of GMP requirements and qualification documentation.
- Ability to independently execute technical qualification activities.
- Professional working proficiency in German.
- Ability to work on-site in Munich, with appropriate authorisation to undertake the contract assignment in Germany.
Experience in any of the following areas would be advantageous:
- Aseptic filling lines / Fill & Finish
- Isolators and sterile manufacturing equipment
- Pharmaceutical process equipment
- Autoclaves, washers and sterilisation systems
- EU GMP Annex 1 environments
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CQV Engineer in München Arbeitgeber: ARTO
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