Région Zurich, Switzerland \u00b7 On-site \u00b7 Long-term Contract \u00b7 Senior level (5–10 years) \u00b7 English required \u00b7 German C1 minimum required
Assignment via a specialist pharma/biotech consulting firm. Full administrative support and mission follow-up included.
Context
A global pharmaceutical company is expanding its sterile manufacturing capabilities in the Zurich region as part of a high-stakes capital investment programme. Recrutis is seeking an experienced CQV Lead to take full ownership of Commissioning, Qualification, and Validation activities across cutting-edge Fill & Finish operations — including isolators, lyophilizers, and high-precision liquid filling lines.
This is a hands‑on leadership role, not a support function. You will sit at the intersection of engineering, compliance, and operations, driving GMP‑compliant execution across complex, multi‑system environments with real ownership and visibility.
If you thrive in technically demanding, fast‑moving environments where precision and accountability are non‑negotiable — this mission was designed for you.
Key Responsibilities
* Lead end‑to‑end CQV execution for liquid and lyophilized vial filling lines, including isolators, lyophilizers, autoclaves, and sterilization equipment
* Define, maintain, and adjust CQV plans and schedules in alignment with project milestones
* Act as primary interface between vendors, automation teams, operations, and engineering during FAT, SAT, IQ, and OQ phases
* Review and support the development and execution of qualification protocols (DQ, IQ, OQ) — digital tools such as Kneat are a strong differentiator
* Ensure full compliance with cGMP, EU Annex 1, EU Annex 15, and client‑specific validation standards
* Coordinate and mentor a cross‑functional CQV team; drive a solution‑oriented culture under pressure
* Plan and execute qualification activities in the context of shutdowns and scheduled maintenance windows
Your Profile
Required:
* 5–10 years of hands‑on CQV experience in sterile Fill & Finish environments (pharma or biotech)
* Scientific or technical degree — Engineering, Life Sciences, Chemistry or equivalent
* Proven track record across lyophilized and liquid fill/finish processes
* Deep knowledge of cGMP, EU Annex 1, EU Annex 15, validation lifecycle principles and cleanroom environments
* Experience managing vendors, third‑party contractors, and cross‑functional teams across FAT/SAT phases
* Fluent English — working language of the international project team
* German C1 minimum — mandatory for daily interactions on site
Strong assets
* Experience with digital qualification platforms (Kneat or equivalent)
* Familiarity with isolator qualification (Grade A/ISO 5, H₂O₂ decontamination, glove integrity)
* Exposure to lyophilizer qualification with dedicated isolators and mass spectrometers
* Experience planning and executing CQV activities during shutdowns
* Solid background in sterility assurance and contamination control strategies aligned with EU Annex 1
* Experience coordinating across multiple simultaneous project streams
What This Mission Offers
* Landmark‑scale sterile manufacturing programme — rare scope and long‑term visibility
* Key role at the heart of Fill & Finish operations — direct impact on quality and patient safety
* International, multicultural environment with cross‑functional exposure at the highest level
* Long‑term contract with strong extension potential
* Full administrative support and mission follow‑up via Recrutis — guaranteed response within 48 hours
* Confidential process — your candidacy is handled with the utmost discretion
Conditions
* Contract: Long‑term consulting mission
* Experience level: Senior (5–10 years)
Fabrice Cattant — Founder of Recrutis, Expert & Executive Search in Life Sciences
#J-18808-Ljbffr