Job Description

Recrutis is supporting a leading biopharmaceutical manufacturing site in Valais, Switzerland, in the search for an MSAT Associate Principal Scientist — Microbial Process Validation, based on site in the Valais region.

Why this role

• You own the process validation strategy: defining it, designing and executing the studies, and authoring the protocols and reports that support it.
• Full lifecycle scope — you also build and maintain the Continued Process Verification programme and the Product Quality Reviews that keep validated processes under ongoing oversight.
• Scientific authority recognised across functions: you review and approve process characterisation documents, deviations and change assessments, and you moderate cross-functional risk assessments.
• Front-line exposure to customer audits and health authority inspections as the process validation reference.
• A mentoring dimension — you support validation training programmes and develop junior validation professionals.

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 March 2027.
• Seniority: 5 to 10 years of experience in biopharmaceutical manufacturing, process development, process validation or MSAT environments.
• Languages: business fluency in English, written and spoken. German is an advantage.

cope

• Design and implement process validation strategies, preparing study designs, protocols and reports in strict compliance with internal procedures and regulatory guidelines.
• Support R&D teams during the process characterisation phase and ensure flawless execution of validation activities.
• Review and approve process characterisation documents for alignment with regulatory standards.
• Coordinate validation assessments on changes and deviations, including approval of the associated documents.
• Develop and maintain a detailed Continued Process Verification (CPV) plan for ongoing process oversight.
• Assess and approve Product Quality Reviews (PQRs) against quality standards.
• Participate in or moderate cross-functional risk assessments to define the scope of validation and study activities.
• Assess validation data against protocol acceptance criteria, support the investigation of deviations from plan and define corrective measures.
• Act as process validation specialist in customer audits and health authority inspections, and collaborate with QA Operations on batch release of processes under validation.
• Support validation training programmes and mentor junior validation professionals.

Profile — Required criteria

• 5 to 10 years of experience in biopharmaceutical manufacturing, process development, process validation or MSAT environments.
• Strong command of the process validation lifecycle.
• Working knowledge of Continued Process Verification (CPV) and Product Quality Reviews (PQRs).
• Solid understanding of GMP requirements and regulatory expectations for biologics and microbial processes.
• Bachelor's or Master's degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology or a related life sciences discipline.
• Business fluency in English, written and spoken.
• Availability to work on site in Valais until the end of March 2027.

Strong assets — Differentiators

• PhD in a relevant life sciences discipline.
• Scientific expertise in microbial manufacturing specifically.
• German language skills.
• Experience supporting audits and inspections as a technical reference.
• Ability to lead cross-functional initiatives and influence stakeholders within a matrix organisation.

Process

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

Keywords

MSAT, Process Validation, Continued Process Verification, CPV, Product Quality Review, PQR, Microbial, Biologics, Process Characterisation, GMP, Validation Master Plan, Deviations, Audits, Valais, Switzerland

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