MSAT Microbial Process Validation Specialist; H​/F

International engineering and technology expertise group, Fortil operates an independent model and brings together more than 2,500 employees. With 30 agencies across 14 countries, Fortil cultivates entrepreneurial freedom and unlocks potential.

In Switzerland (Valais Canton), we are looking for a MSAT Microbial Process Validation Specialist to join the team responsible for establishing, monitoring, and qualifying microbiological processes in production. The role holder will help ensure regulatory compliance, process robustness, and reproducibility of results, working closely with R&D, Quality Assurance, Production, and Validation teams.

• Design and implement process validation strategies across the product lifecycle, ensuring compliance with internal quality standards, GMP requirements, and regulatory expectations.
• Author, review, and approve validation documentation, including study designs, protocols, reports, and technical assessments related to process validation activities.
• Provide MSAT support during process characterization, technology transfer, scale-up, and commercial manufacturing activities.
• Collaborate with Process Development, Manufacturing, Quality, and Engineering teams to ensure successful execution of process validation and lifecycle management initiatives.
• Lead or support risk assessments to define validation approaches, study scopes, critical process parameters, and control strategies.
• Evaluate validation and process performance data against predefined acceptance criteria, identifying trends, risks, and opportunities for process improvement.
• Support investigations related to process deviations, out-of-trend results, and manufacturing events, contributing to root cause analysis and CAPA implementation.
• Assess the impact of process changes and participate in change control activities to ensure continued process robustness and compliance.
• Develop and maintain Continued Process Verification (CPV) programs, monitoring process performance and supporting ongoing process improvements.
• Contribute to Product Quality Reviews (PQRs) and other lifecycle management activities by providing technical expertise and process performance assessments.
• Act as an MSAT process validation subject matter expert during customer audits, regulatory inspections, and internal quality assessments.
• Partner with Quality Assurance to support process validation campaigns and associated batch disposition activities.
• Facilitate effective collaboration between MSAT, Manufacturing, Validation, Engineering, and Quality functions to ensure alignment on validation and process performance objectives.
• Mentor junior colleagues and support training initiatives related to process validation, process monitoring, and lifecycle management best practices.

• Master’s degree (Bac+5) in biotechnology, microbiology, biochemistry, process engineering, or a related field.
• Bachelor's or Master’s degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, or a related Life Sciences discipline. PhD preferred.
• 5-10 years of experience in biopharmaceutical manufacturing, including process development, process validation, and MSAT environments.
• Strong understanding of Process Validation Lifecycle, Continued Process Verification (CPV), Product Quality Reviews (PQRs), GMP requirements, and regulatory expectations for biologics and microbial processes.
• Fluent in English;
  German is a plus.

• Tailored support for upskilling and career development.
• Exposure to international projects and mobility opportunities.
• The opportunity to become an associate and contribute to collective success.
• Commitment to community initiatives and association-driven projects.
• Policy supporting parenthood and work-life balance.

Fortil is committed to equal opportunities. All positions are open to people with disabilities, without distinction of gender, origin, or sexual orientation.