MSAT Microbial Process Validation Specialist

Main Responsibilities:

• Design and implement process validation strategies, preparing validation documents (study designs, protocols, and reports) in strict compliance with organisations procedures and regulatory guidelines.
• Provide support to R&D teams during the process characterization phase, ensuring the flawless execution of validation activities
• Review and approve process characterization documents to ensure their 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, strictly ensuring their adherence to quality standards.
• Participate in or moderate cross-functional Risk Assessments to define the scope of validation/ study activities.
• Assess validation data for conformance to protocol acceptance criteria and support the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures.
• Process validation specialist in Customer Audits and HA Inspections.
• Ensure the collaboration with QA Ops for batch release of process in validation.
• Supporting validation training programs and train/ mentor junior employees to better accomplish and perform in their duties as MSAT validation professionals.
• Ensure the organization of meetings for an efficient collaboration with MSAT, QA Validation, Cleaning Validation and QA Qualification (as required)

Required:

• Relevant working/residency permit or Swiss/EU-Citizenship is required
• Bachelor's or Master's degree in, Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, Related Life Sciences discipline. PhD preferred.
• 5-10 years of experience in, Biopharmaceutical manufacturing
• Process development, Process validation in MSAT environments
• Strong understanding of: Process Validation Lifecycle, Continued Process Verification (CPV), Product Quality Reviews (PQRs),
• Regulatory expectations for biologics and microbial processes
• Business fluency in English (written and spoken) and German language skills are advantageous.
• Excellent 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.