MSAT Microbial Process Validation Specialist / MSAT Microbial Process Validation Specialistess

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Job Opportunity: MSAT Microbial Process Validation Specialist

Our client, a global market leader in the production and process support of active pharmaceutical ingredients across both the chemical and biotechnology sectors, is seeking an MSAT Microbial Process Validation Specialist for an 8-month contract role based in the Valais area, Switzerland (on-site presence).

About the Role

The ideal candidate will possess robust scientific expertise in microbial or biopharmaceutical manufacturing, paired with an in-depth knowledge of process validation and regulatory requirements. This influential collaborator will excel in leading cross-functional initiatives, driving compliance, supporting inspections and audits, and contributing to the continuous enhancement of validation strategies throughout the product lifecycle.

The MSAT Microbial Process Validation Specialist will provide scientific and regulatory know-how in process validation for biopharmaceutical manufacturing processes. Responsibilities include defining validation strategies, designing and executing validation studies, and authoring process validation protocols and reports in accordance with the company’s Validation Master Plans (VMPs), SOPs, and global regulatory requirements.

The specialist will also develop and maintain Continued Process Verification (CPV) programs and Product Quality Reviews (PQRs) to ensure ongoing process oversight, compliance, and lifecycle management of validated processes.

Main Responsibilities

• Design and implement process validation strategies, preparing validation documents (study designs, protocols, and reports) in strict compliance with organizational procedures and regulatory guidelines.
• Support R&D teams during the process characterization phase, ensuring seamless execution of validation activities.
• Review and approve process characterization documents to ensure alignment with regulatory standards.
• Coordinate validation assessments on changes and deviations, including the approval of deviation and change documents.
• Develop and maintain a detailed continued process verification plan to successfully implement ongoing process oversight.
• Assess and approve Product Quality Reviews, ensuring adherence to quality standards.
• Participate in or moderate cross-functional Risk Assessments to define the scope of validation/study activities.
• Evaluate validation data for conformance to protocol acceptance criteria and support investigations into deviations, defining associated corrective measures.
• Serve as the process validation specialist during Customer Audits and HA Inspections.
• Collaborate with QA Ops for the batch release of processes in validation.
• Support validation training programs and mentor junior employees to enhance their performance as MSAT validation professionals.
• Organize meetings for efficient collaboration with MSAT, QA Validation, Cleaning Validation, and QA Qualification, as necessary.

Qualifications

• Relevant working/residency permit or Swiss/EU citizenship required.
• 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, process development, and process validation in MSAT environments.
• Strong understanding of Process Validation Lifecycle, Continued Process Verification (CPV), and Product Quality Reviews (PQRs).
• Familiarity with regulatory expectations for biologics and microbial processes.
• Business fluency in English (written and spoken); German language skills are advantageous.
• Exceptional verbal, written, and presentation skills.
• Comfortable communicating with senior leadership and external stakeholders.
• Strong networking and relationship-building capabilities.
• Able to engage customers and cross-functional teams effectively.

How to Apply

Interested in learning more about CTC and this opportunity? Apply online using the form below. Please note that only applications matching the job profile will be considered.