CQV Engineer – Fill & Finish

Recrutis is supporting one of its clients, a leading global pharmaceutical company, in the search for a CQV Engineer – Fill & Finish.

You will take full technical ownership of Commissioning, Qualification, and Validation activities for sterile Fill & Finish equipment and supporting utilities, within a large-scale GMP site transformation programme.

Key Information

• Location: Zürich region, Switzerland (on-site, 100%)
• Contract: Long-term consulting assignment
• Start date: ASAP
• Seniority: 5+ years in CQV / Fill & Finish
• Industry: Pharma / Biotech (GMP environment)
• Languages: German C1 mandatory (daily on-site communication) — English is a strong plus

Your Role You will own CQV execution for liquid and lyophilized vial filling lines — including isolators, lyophilizers, autoclaves, and precision dosing systems — as primary author and executor of qualification protocols, not solely as reviewer.

Key Responsibilities

• Write and execute IQ/OQ/PQ protocols for Fill & Finish equipment and utilities — primary author and executor
• Lead commissioning and start-up activities (FAT/SAT, Vendor Qualification)
• Qualify supporting utilities: WFI, Purified Water, Clean Steam, HVAC systems
• Ensure compliance with cGMP, EU Annex 1, GAMP5, FDA 21 CFR
• Manage deviations and non-conformances identified during qualification
• Coordinate cross-functional interfaces: automation, engineering, operations, QA

Systems You'll Work With

• Filling lines: liquid and lyophilized vials (piston and peristaltic pump systems)
• Isolators: Grade A / ISO 5, HO decontamination, glove integrity testing
• Lyophilizers with dedicated isolators
• Support utilities: autoclaves, HVAC, stopper treatment stations, WFI/PW loops
• Digital validation tools: Kneat or equivalent (strong plus)

Your Profile

• 5+ years in CQV within sterile Fill & Finish pharma or biotech operations
• Primary author and executor of IQ/OQ/PQ protocols — not reviewer/approver only
• Hands-on experience qualifying utilities (WFI, Clean Steam, HVAC)
• Solid knowledge of cGMP, EU Annex 1, GAMP5, FDA 21 CFR
• Proven FAT/SAT ownership and vendor qualification experience
• Experience in greenfield or revamping programmes is a strong plus
• German C1 mandatory — English is a strong plus

Why This Role

• Large-scale GMP site transformation programme (650M€+) — greenfield and revamping
• Full technical ownership — not a support or review-only role
• Long-term mission with high project visibility in an international environment

Keywords CQV, IQ OQ PQ, Fill & Finish, Isolator, Lyophilizer, RABS, GMP, EU Annex 1, GAMP5, FAT SAT, WFI, HVAC, Clean Steam, Commissioning, Validation, Pharma, Biotech, Zürich, Switzerland

Process Confidential recruitment process with response within 48 hours. Immediate need — priority review of relevant applications.

Fabrice Cattant — Founder, Recrutis | Expert & Executive Search in Life Sciences