CQV Engineer (Fill Finish)

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.