We are seeking a skilled and motivated Process CQV Engineer to join our team for a high-profile pharmaceutical project in Munich. The successful candidate will be primarily responsible for the commissioning, qualification, and validation (CQV) of automated Optima filling lines. The role demands hands-on experience with pharmaceutical or biopharmaceutical filling lines, with a preference for Optima platform expertise.
Key Responsibilities:
- Lead and execute CQV activities for automated Optima filling lines, including FAT/SAT, commissioning, IQ, OQ, and PQ protocols.
- Develop, review, and approve CQV documentation in compliance with cGMP, FDA, and EU regulations.
- Collaborate with project engineering, automation, quality assurance, and equipment vendors to ensure successful line start-up and handover.
- Troubleshoot and resolve process and equipment issues during commissioning and qualification phases.
- Support process characterization, cleaning validation, and media/batch simulation runs as required.
- Drive continuous improvements and ensure efficient, high-quality CQV execution.
- Maintain clear and concise project tracking, status updates, and reporting to management.
- Adhere to all site standards relating to safety, quality, and documentation.
Requirements:
- Bachelor's degree (or higher) in Engineering, Pharmaceutical Sciences, or a related technical field.
- Direct hands-on experience with automated pharmaceutical or biopharmaceutical filling lines is essential.
- Specific experience with Optima filling lines strongly preferred; other major platforms (e.g., Bausch+Ströbel, IMA, Syntegon) also considered.
- Proven track record in commissioning, qualification, and validation (CQV) of process equipment.
- Excellent understanding of GMP, FDA, Annex 1, and other relevant regulatory guidelines.
- Strong documentation skills and familiarity with risk-based qualification approaches.
- Excellent troubleshooting and problem-solving abilities.
- Effective communication skills in English; German language proficiency is advantageous.
- Ability to work flexibly in a fast-paced, multi-disciplinary environment.
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CQV Engineer (Fill Finish) in München Arbeitgeber: EFOR
Als Arbeitgeber in der biopharmazeutischen Branche bieten wir Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf Teamarbeit und kontinuierliche Verbesserung setzt. Unsere Unternehmenskultur fördert nicht nur die persönliche und berufliche Weiterentwicklung, sondern bietet auch attraktive Benefits wie flexible Arbeitszeiten und ein unterstützendes Arbeitsumfeld. In der Region Rheinland-Pfalz profitieren Sie von einer hervorragenden Lebensqualität und einer starken Gemeinschaft, die Ihre Karriere im Bereich Clean Utilities vorantreibt.
