Job Description

Recrutis is supporting a leading biopharmaceutical manufacturing site in Valais, Switzerland, in the search for a QA Validation Specialist, based on site in the Valais region.

Why this role

• QA ownership of qualification and validation activities on a large-scale mammalian cell culture and biologics capacity expansion programme — advanced automation, complex process control, large-scale manufacturing.
• You join at a critical phase of the project, in a compact core team reporting directly to the Head of QA Validation & Qualifications.
• Real technical authority: you review and approve SOPs, validation protocols, reports, change controls and deviations, and you defend those positions in front of Operations, Engineering, clients and regulatory bodies.
• Direct exposure to customer audits and health authority inspections under both EU GMP and FDA regulations.
• Broad qualification scope — autoclaves, clean utilities, shipping validation, temperature mapping of controlled storage rooms and equipment.

Key information

• Location: Valais, Switzerland — on-site presence at the manufacturing site.
• Contract: consulting assignment (mission).
• Duration: start as soon as possible, assignment running until the end of December 2026.
• Seniority: 2 to 6 years of validation / qualification experience.
• Languages: English at professional working level. German is a strong plus.

Scope

• Perform QA oversight of validation review and qualification activities, ensuring GMP equipment, facilities and systems are continuously maintained in a validated and qualified state.
• Perform change control assessments for GMP equipment, facilities and systems, and the associated validation activities, to ensure compliance with regulatory requirements.
• Review and approve SOPs, validation protocols, validation reports, change controls, deviations and other GMP records, providing strong technical expertise.
• Develop validation protocols from validation plans where applicable.
• Apply qualification procedures across Installation Qualification (IQ), autoclaves, clean utilities, shipping validation, and temperature mapping of controlled storage rooms and equipment.
• Schedule your own tasks and Level 1 tasks as determined by the Validation Manager.
• Perform assigned Quality Systems activities: Document Management System (DMS), Laboratory Information Management System (LIMS), validation and qualification management system (Kneat), and Trackwise (change control, deviations, CAPA).
• Participate in audits and inspections demonstrating compliance of facility, equipment and systems with European and US (FDA) regulations, and contribute to continuous improvement initiatives.

Profile — Required criteria

• 2 to 6 years of validation / qualification experience in a GMP-regulated pharmaceutical, biotech or cell & gene therapy environment.
• Full command of the validation lifecycle: IQ, OQ, PQ, and maintaining systems in a validated state.
• Hands-on change control experience and documentation review experience.
• Proven experience reviewing and approving SOPs, validation protocols, validation reports, deviations, CAPAs and change controls.
• Familiarity with EU GMP and FDA regulations.
• English at professional working level.
• Availability to work on site in Valais until the end of December 2026.

Strong assets — Differentiators

• German language skills.
• Science or technical degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy or a related field — academic background is not essential where the working experience is there.
• Practical experience with Kneat, Trackwise, DMS or LIMS.
• Experience in cell & gene or mammalian cell culture manufacturing environments.
• Ability to pick things up rapidly and work autonomously in a fast-paced, multicultural and highly collaborative setting.

Process

Confidential recruitment process. Response within 48 hours for applications meeting required criteria. Active mandate, priority review.

Keywords

QA Validation, Qualification, IQ OQ PQ, Validation Lifecycle, Change Control, Deviations, CAPA, GMP, EU GMP, FDA, Kneat, Trackwise, Biologics, Cell and Gene, Valais, Switzerland

Fabrice Cattant — Founder, Recrutis | Expert & Executive Search in Life Sciences