QA Validation Specialist (M/F)

About the role

Fortil is seeking a QA Validation Specialist to join its Life Sciences team in Visp, supporting a major expansion in mammalian cell culture and biologics manufacturing. The role is onsite and focuses on ensuring GMP equipment, facilities and systems remain validated throughout their lifecycle.

Key responsibilities

• Provide QA oversight of qualification and validation activities for GMP equipment, facilities and systems.
• Review and approve validation documentation, including validation plans, IQ/OQ/PQ protocols, reports, SOPs, deviations, CAPAs and change controls.
• Develop validation protocols based on approved plans and perform change control assessments.
• Support qualification and validation of autoclaves, clean utilities, controlled storage, temperature mapping, shipping processes, manufacturing equipment and automated systems.
• Collaborate with Operations, Engineering, Quality and other stakeholders; participate in audits and regulatory inspections.
• Ensure compliance with EU GMP and US FDA requirements and drive continuous improvement.

Required profile

• 2‑6 years of experience in qualification and validation within a GMP‑regulated pharmaceutical, biotechnology or cell‑and‑gene therapy environment.
• Strong understanding of the CQV lifecycle and practical experience with IQ, OQ and PQ activities.
• Proven ability to review and approve validation protocols, reports, change controls, deviations and CAPAs.
• Good knowledge of cGMP regulations, EU GMP and US FDA requirements.
• Fluent written and spoken English; German is a plus.
• Academic background in engineering, biotechnology, chemistry, biology, pharmacy or related discipline is advantageous.

Required skills

• IQ, OQ, PQ execution and documentation
• cGMP, EU GMP, US FDA compliance
• Change control, deviation and CAPA management
• DMS, LIMS, Kneat, TrackWise systems
• Validation of autoclaves, clean utilities, temperature mapping, shipping processes and automated manufacturing equipment

What we offer

• Support for professional development and continuous learning
• Dynamic, multicultural work environment
• Opportunity to contribute to a high‑growth biologics manufacturing project