CQ Engineer – Formulation Prep (12‑Month Contract)

About the role

We are seeking a CQ Engineer to join a high‑impact pharmaceutical project near Frankfurt. The role focuses on the commissioning and qualification of formulation preparation equipment within a GMP‑regulated environment, supporting a 12‑month fixed‑term contract.

Key responsibilities

• Develop and execute C&Q lifecycle documentation (URS, DQ, IQ, OQ, PQ) for formulation tanks, component preparation and sterile filtration units.
• Collaborate with Validation, QA, Engineering and Operations teams to meet C&Q milestones.
• Plan, conduct and support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Apply Quality Risk Management (QRM) principles to identify and mitigate risks during commissioning.

Required profile

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences or a related discipline.
• Extensive experience in C&Q within a GMP‑regulated biopharma or biotech facility.
• Proven experience with formulation and sterile component preparation equipment.
• Strong understanding of validation principles, GMP documentation and equipment lifecycle management.

Required skills

• URS, DQ, IQ, OQ, PQ documentation.
• Quality Risk Management (QRM).
• Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Formulation tanks and sterile filtration units.