MSAT Microbial Process Validation Specialist

CTC Resourcing Solutions AG seeks a Senior MSAT Microbial Process Validation Specialist for an 8-month on-site contract in Valais, Switzerland, focusing on biopharmaceutical process validation and regulatory compliance.

This position serves as a key scientific and regulatory resource within the Microbiology, Safety, and Toxicology (MSAT) team. The specialist will oversee the validation lifecycle for biopharmaceutical manufacturing processes, ensuring that all activities align with strict quality standards and regulatory expectations while supporting cross-functional teams in research and development.

Responsibilities

• Create and execute validation strategies, including the drafting of study designs, protocols, and final reports in accordance with internal procedures and external regulations.
• Collaborate with R&D groups during the process characterization stage to guarantee the accurate execution of validation tasks.
• Evaluate and authorize process characterization documentation to confirm compliance with regulatory benchmarks.
• Manage validation assessments for process changes and deviations, including the review and approval of related documentation.
• Establish and upkeep a comprehensive continued process verification plan to maintain ongoing oversight of manufacturing processes.
• Review and approve Product Quality Reviews to ensure strict adherence to established quality standards.
• Lead or participate in cross-functional risk assessments to determine the scope of validation and study activities.
• Analyze validation data against protocol acceptance criteria and assist in investigating deviations, defining corrective actions as needed.
• Represent the company during customer audits and Health Authority inspections as a process validation expert.
• Work closely with QA Operations to facilitate the batch release of processes currently under validation.
• Contribute to validation training initiatives and mentor junior MSAT validation professionals to enhance their performance.
• Organize and facilitate meetings with MSAT, QA Validation, Cleaning Validation, and QA Qualification teams to ensure efficient collaboration.

Requirements

• Possession of a valid Swiss or EU work/residency permit, or Swiss/EU citizenship.
• A Bachelor's or Master's degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, or a related life sciences field.
• Between 5 and 10 years of professional experience in biopharmaceutical manufacturing.
• Proven background in process development and process validation within MSAT environments.
• Deep knowledge of the process validation lifecycle, continued process verification (CPV), and product quality reviews (PQRs).
• Strong understanding of regulatory requirements specific to biologics and microbial processes.
• Business-level fluency in English, both written and spoken.

Nice to have

• A PhD degree is preferred.
• Proficiency in the German language is considered an advantage.

About the company

The client is a global market leader in the production and process support of active pharmaceutical ingredients, operating across both chemical and biotechnology sectors. The ideal candidate will be an influential collaborator capable of leading cross-functional initiatives, driving compliance, supporting inspections and audits, and contributing to the continuous improvement of validation strategies throughout the product lifecycle.

• Opportunity to work with a global market leader in active pharmaceutical ingredient production.
• Role involves leading cross-functional initiatives and driving compliance.
• Focus on continuous improvement of validation strategies across the product lifecycle.
• Collaborative environment supporting inspections, audits, and mentorship of junior staff.