About this role
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 Process Validation Expert. In this role, you will be responsible for the process validation activities in our biopharmaceutical plant and help ensure the highest standards of quality and compliance.
Key responsibilities:
- Develop and define the process validation strategies for the assigned projects in the Mammalian Large Scale facility of Lonza Visp.
- Prepare/Author process validation protocols and reports, including supporting studies (e.g., hold time, resin lifetime, leachable/extractable studies) according to Lonza procedure and in compliance with regulatory.
- Support Process Development (PD) teams during the process characterization phase.
- Preparation and maintenance of a detailed continued process verification plan.
- Assess, review and approve Product Quality Reviews (PQR).
- Reviewing and approving of process related documents.
- Assess process 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 process validation assessment and approval).
- Represents Lonza in customer-facing meetings
- Assist in developing programs and Standard Operative Procedures (SOP) to meet industry standards and regulatory requirements
- Act as process 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 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.
- Strong 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.
- Able to come on site in Visp 60% of the time
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
About Lonza
Swiss contract development and manufacturing organization (CDMO) providing biologics, cell, and gene therapy production services.
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