Global Pharmaceutical Company – Schaffhausen, Switzerland
Long-term assignment| Schaffhausen (CH)| English required – German a plus
Context
As part of large-scale projects at its Schaffhausen site – including a greenfield facility, laboratory revamping and EU Annex 1 GMP compliance upgrade – a global pharmaceutical leader is looking for a Qualification/Validation Engineer to support the commissioning and qualification of equipment and systems.
Key Responsibilities
* Author and execute qualification protocols (IQ/OQ/PQ) for equipment and systems
* Drive commissioning and start-up activities
* Ensure qualification documentation complies with GMP standards
* Manage deviations and non-conformances identified during qualifications
* Collaborate with Engineering, Production and Quality Assurance teams
* Participate in FAT/SAT phases at vendor sites and on-site
* Contribute to the validation strategy for greenfield and revamping projects
Your Profile
* Scientific or technical degree (engineering, pharmacy, chemistry)
* Proven experience (5+ years) in qualification/validation within a GMP pharma or biotech environment
* Proficient in authoring and executing IQ/OQ/PQ protocols
* Experience in commissioning / equipment start-up
* Knowledge of GMP frameworks (EU, FDA) and GAMP guidelines
* Fluent English – mandatory
* German appreciated but not mandatory
* Greenfield project experience is a strong asset
Whats Offered
* Integration into a 650M€+ investment programme
* Large-scale greenfield and upgrade projects
* International and multicultural environment
Position managed by Recrutis on behalf of GXP Consulting Switzerland.
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