Qualification & Validation Engineer – IQ​/OQ​/PQ | FAT​/SAT | Greenfield GMP Pharma​/Biotech | Long

🤝Assignment via GXP Consulting Switzerland — specialist pharma/biotech consulting firm. Full administrative support and mission follow‑up included.

A global pharmaceutical company is undergoing large‑scale transformation at its Schaffhausen site — a 650M€+ investment programme including a greenfield facility build, laboratory revamping, and EU Annex 1 GMP compliance upgrade.

As part of this programme, GXP Consulting Switzerland is looking for an experienced Qualification & Validation Engineer to support the commissioning and qualification of equipment and systems across multiple project streams.

A long‑term assignment at the heart of one of Europe’s most ambitious pharma site transformations — with real technical scope and autonomy.

• IQ/OQ/PQ for equipment and systems — Author and execute qualification protocols —
• Drive commissioning and start‑up activities on new equipment and utilities
• Ensure qualification documentation complies with GMP standards and site procedures
• Manage deviations and non‑conformances identified during qualification activities
• FAT/SAT phases at vendor sites and on‑site — Participate in
• Collaborate with Engineering, Production and Quality Assurance teams across project streams
• Contribute to the validation strategy for greenfield and revamping projects

• Scientific or technical degree — engineering, pharmacy, chemistry or equivalent
• qualification and validation within a GMP pharma or biotech environment — 5+ years of hands‑on experience in
• IQ/OQ/PQ protocols — independently, not just as support — Proficient in authoring and executing
• EU guidelines, FDA 21 CFR, GAMP5 — Knowledge of GMP frameworks:

• Experience in commissioning and equipment start‑up — FAT/SAT, vendor qualification
• Greenfield project experience — validation from scratch is a strong differentiator
• German appreciated — facilitates daily interactions on site
• Autonomous profile, comfortable in a complex multi‑project environment

• 650M€+ investment programme — rare scope at this scale — Integration into a landmark
• Large‑scale greenfield and upgrade projects — build quality systems from the ground up
• International and multicultural environment — global standards, cross‑functional teams
• Long‑term contract through GXP Consulting Switzerland, with extension potential
• Structured mission support: administrative management, on‑site follow‑up, continuity between assignments
• Confidential process — guaranteed response within 48 hours

• your contacts know your field — GXP Consulting is a specialist firm in pharma/biotech missions —
• Access to a portfolio of GMP missions across Switzerland and Europe — continuity between assignments
• Full administrative and technical support throughout your mission
• A long‑term partner for specialists who prefer mission‑based work over permanent positions

Confidential mission managed by Recrutis on behalf of GXP Consulting Switzerland.

Your application will be handled with full discretion. Guaranteed response within 48 hours.

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