Process Validation Specialist (f/m/d) (80-100%)

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!

• Design and implement process validation strategies, preparing validation documents (study designs, protocols, and reports) in strict compliance with Lonza 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.

• Master’s degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or equivalent experience.

• Proven experience in project management within Operations, MSAT, Quality, and Compliance.

• Demonstrated 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 deadlines.

• Proficient communication skills 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.