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MSAT Validation Expert m/w/d (EN)
[17699]
MSAT, Cleaning Validation
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. As part of the MSAT (Manufacturing Science & Technology) Validation team of our Large-Scale Mammalian facility in Visp, we are looking for a Validation Expert. In this role, you will be supporting the process and cleaning validation activities in our biopharmaceutical plant and help ensure the highest standards of quality and compliance. Project title: MSAT Validation Expert m/w/d Type of employment: Payroll Industry: Biotech Skills: MSAT,Cleaning Validation Project start: 1 Aug 2026 Project duration: 30 Apr 2027 Location: 3930 Visp, Schweiz Key responsibilities: • Support the development of validation strategies (process or cleaning, as defined) for the assigned projects in the Mammalian Large Scale facility of Lonza Visp. • Prepare/author validation protocols and reports (for process or cleaning, as defined) according to Lonza procedure and in compliance with regulatory. • Reviewing and approving process/cleaning related documents. • Support stakeholders, as requested, during the execution phase. • Assess validation data against acceptance criteria and support investigations of deviations (and approve DR) • Act as a Subject Matter Expert (SME) for non-conformity records and change requests (responsible for the validation assessment and approval). • Support PQ studies (protocol/report authoring) related to process validation. • Represent, as requested, Lonza in customer-facing meetings • Assist, as requested, in developing programs and Standard Operative Procedures (SOP) to meet industry standards and regulatory requirements • Act, as requested, as validation SME during inspections by healthcare authorities and customer audits. Key requirements: • Master’s or PhD degree in biotechnology, life sciences, or related disciplines. • Working experience in process validation (ideally as well in cleaning validation) within a cGMP-regulated biopharmaceutical environment. • Proven experience in managing complex projects, ideally in MSAT or Quality. • 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 mammalian cell culture). • Experience engaging with regulatory agencies (Swissmedic, FDA, etc.) • Excellent communication, technical writing, and stakeholder management skills. • Fluency in English (written and spoken); German is an advantage.
Luca Furler