Today, Lonza is a global leader in life sciences operating across five 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.
Join our remarkable team at Lonza AG in Visp, Switzerland as a Process Validation Specialist (f/m/d). In this role, you will contribute to top-tier process validation in our Biologics division, ensuring seamless manufacturing processes in biopharmaceutical plants. This is an outstanding opportunity to be part of a world-class team where you can determine the future of biopharmaceutical manufacturing!
Key responsibilities:
Develop the strategy for the process-specific validations in Mammalian Large Scale.
Preparation of validation documents (study design / writing protocols and reports) according to Lonza procedure and in compliance with regulatory.
Communication with customers.
Supporting PD teams during the process characterization phase.
Reviewing and approving of process related documents.
Responsibility for the validation assessment on changes and deviations (and approval of deviation and changes).
Preparation and maintenance of a detailed continued process verification plan.
Assessing and approving of Product Quality Reviews (PQR).
Contact person for process validation during inspections by authorities or customer audits.
Key requirements:
Master’s degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or equivalent experience.
Proven experience in project management within Operations, MSAT, Quality, and Compliance.
Proven ability to interact effectively with various collaborators within the organization and with regulatory agencies (e.g., Swissmedic, FDA).
Previous experience in mammalian cell culture processes is an advantage.
Outstanding ability to manage multiple tasks simultaneously and meet tight schedules.
Proficient in English (written and spoken); proficiency in German is highly appreciated.
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.