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.

Key responsibilities

• 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 perfect 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 efficiently implement ongoing process oversight.
• Assess and approve Product Quality Reviews, rigorously ensuring their adherence to quality standards.
• Participate in or moderate cross-functional Risk Assessments to define the scope of validation/ study activities.
• Assess validation data for conformance to protocol acceptance criteria and support the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures.
• Process validation specialist in Customer Audits and HA Inspections.

Key requirements:

• Master’s degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or equivalent experience.
• Prior experience in GMP-regulated environment.
• 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 microbial cell culture processes and process validation is an advantage.
• Outstanding ability to lead multiple tasks simultaneously and meet tight deadlines.
• Proficient interpersonal skills in English (written and spoken); proficiency in German is 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.