CQV Engineer (Fill Finish)

EFOR; München; On-site; EUR 70,000 - 100,000; Full time

Job summary

EFOR seeks a skilled Process CQV Engineer for a high-profile pharmaceutical project in Munich. The role focuses on commissioning, qualification, and validation of automated Optima filling lines, with hands-on work across FAT/SAT, IQ/OQ/PQ, and CQV documentation.

The candidate should bring direct experience with pharmaceutical filling lines, strong GMP knowledge, and excellent English communication. German language skills are advantageous for on-site collaboration at Munich facilities.

Qualifications

• Bachelor's degree in Engineering, Pharmaceutical Sciences, or related field.
• Hands-on experience with automated pharmaceutical or biopharmaceutical filling lines.
• Experience with CQV for filling lines, preferably Optima.
• Knowledge of GMP, FDA, Annex 1 and regulatory guidelines.
• Strong documentation and communication skills; English required; German a plus.

Responsibilities

• Lead 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 for 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 CQV execution.
• Maintain clear project tracking, status updates, and reporting to management.
• Adhere to all site standards relating to safety, quality, and documentation.

Skills

CQV

Commissioning

Validation

GMP knowledge

FAT/SAT

English proficiency

Education

Bachelor's degree in Engineering

Tools

Optima platform

Job description

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.