MSAT Validation Expert
Location: Visp, Switzerland
Contract Type: Contract
Duration: 9 Month Contract
Hours: 41 hours/week
About the Role
Our client, a global leader in life sciences with operations across three continents, is looking for an MSAT Validation Expert to join the MSAT (Manufacturing Science & Technology) Validation team within a Large-Scale Mammalian biopharmaceutical manufacturing facility in Visp, Switzerland.
In this role, you will support process and cleaning validation activities within a biopharmaceutical plant, helping to ensure the highest standards of quality and regulatory compliance. This is a great opportunity for a validation professional to work at the center of a complex, regulated manufacturing environment, with direct exposure to health authority inspections and customer audits.
Key Responsibilities
- Support the development of validation strategies (process or cleaning, as assigned) for projects within the Mammalian Large Scale facility
- Prepare and author validation protocols and reports (process or cleaning, as assigned) in accordance with internal procedures and regulatory requirements
- Review and approve process/cleaning-related documentation
- Support stakeholders during the execution phase of validation activities, as requested
- Assess validation data against acceptance criteria; support deviation investigations and approve Deviation Reports (DRs)
- Act as Subject Matter Expert (SME) for non-conformity records and change requests, including validation assessment and approval
- Support Performance Qualification (PQ) studies through protocol and report authoring
- Represent the organization in customer-facing meetings, as requested
- Contribute to the development of programs and Standard Operating Procedures (SOPs) to meet industry and regulatory standards
- Act as validation SME during health authority inspections and customer audits, as requested
Key Requirements
- Master's or PhD in Biotechnology, Life Sciences, or a related discipline
- Working experience in process validation within a cGMP-regulated biopharmaceutical environment; cleaning validation experience is a plus
- Proven experience managing complex projects, ideally within MSAT or Quality functions
- Strong ability to manage multiple tasks and meet deadlines effectively
- Understanding of upstream and downstream processes, preferably in mammalian manufacturing
- Exposure to process development, scale-up, and/or manufacturing, preferably in mammalian cell culture
- Experience engaging with regulatory agencies (e.g., Swissmedic, FDA)
- Excellent communication, technical writing, and stakeholder management skills
Technical Skills
Must Have
- cGMP Regulations
- MSAT
- Process Validation
Nice to Have
Languages
- Fluency in English (written and spoken) required
- German language skills advantageous