Qualification/Validation Engineer

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.