Région Zurich · On-site · Long-term Contract · Senior level (5+ years) · English required · German strongly preferred
Assignment via a specialist pharma/biotech consulting firm — GXP Consulting Switzerland. Full administrative support and mission follow-up included.
Context A global pharmaceutical company is scaling up its site in the Zurich region as part of one of the most ambitious GMP site transformation programmes in Europe — a 650M€+ investment encompassing a greenfield facility build, EU Annex 1 upgrade, aseptic filling capacity expansion, and full laboratory revamping.
To support this programme, GXP Consulting Switzerland is looking for an experienced GMP Compliance & Validation Engineer to sit at the intersection of quality assurance and validation — ensuring GMP compliance across equipment qualification activities, project deliverables, and ongoing production operations.
This is not a desk-based QA role. The right candidate is equally comfortable authoring qualification protocols and supporting regulatory inspection readiness on the floor.
Key Responsibilities Qualification & Validation
Author and execute IQ/OQ/PQ protocols for equipment and systems — with autonomy, not only in a support capacity
Contribute to commissioning and start-up activities across multiple project streams
Ensure qualification documentation meets GMP standards — EU Annex 1, FDA 21 CFR, GAMP5
Participate in FAT/SAT at vendor sites and on-site
GMP Compliance
Manage deviations, CAPAs and change controls in a complex, multi-project environment
Support and lead internal and external audits; prepare for regulatory inspections (FDA, Swissmedic, EMA)
Author, review and update quality documentation: SOPs, protocols, validation reports
Guide cross‑functional project teams on GMP and regulatory requirements
Cross‑functional interface
Collaborate with Production, Engineering, QA and external vendors
Contribute to the continuous improvement of the site Quality Management System
Your Profile Required:
5+ years of hands‑on experience in GMP compliance and/or qualification/validation within pharma or biotech
Experience authoring and executing IQ/OQ/PQ protocols — as primary author and executor, not only reviewer
Solid knowledge of GMP frameworks: EU Annex 1, FDA 21 CFR, ICH guidelines
Experience managing deviations, CAPAs and change controls in a project environment
Scientific or technical degree — pharmacy, chemistry, biology or engineering
Fluent English — mandatory
German B1/B2 — strongly preferred (daily interactions on site in German)
Strong assets:
Experience in both qualification/validation and GMP compliance roles
Exposure to inspection readiness and regulatory audit support
Comfortable working across multiple simultaneous projects — autonomous and solution‑oriented
Familiarity with aseptic manufacturing environments
Languages English: required
German: B1/B2 strongly preferred
What This Mission Offers Long‑term assignment at the heart of one of Europe's most ambitious pharma site transformations
Rare scope: greenfield build, EU Annex 1 aseptic compliance, GMP revamping, clinical batch scale‑up
International and innovative working environment — cross‑functional teams, global standards
A genuine opportunity to shape quality systems from the ground up on a major industrial site
Confidential process — response guaranteed within 48 hours
Conditions Location: Zurich Region, Switzerland — full on‑site presence required
Contract: Long‑term consulting mission
Start date: ASAP
Experience level: Senior (5+ years)
Fabrice Cattant — Founder of Recrutis, Expert & Executive Search in Life Sciences
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