Join to apply for the Process Validation Expert MSAT (m/f/d) role at Lonza.
Switzerland, Visp
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 a member of the MSAT (Manufacturing Science & Technology) organization in Visp, you are responsible for the successful process validation activities of mammalian manufacturing processes. In this role, you will manage manufacturing process validation in our biopharmaceutical plant, including assessment of process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs).
Key Responsibilities
* Responsible for the Process Performance Qualification and Continued Process Verification activities.
* Responsible for planning, execution, and documentation of validation protocols and reports in alignment with regulatory expectations (FDA, EMA, ICH) and studies intended to demonstrate suitability and robustness of manufacturing processes.
* Manage technical risks associated with process validation, and achieve project completion aligned with project management goals.
* Work closely with MSAT process experts and cross‑functionally with QA, QC, Manufacturing, and Regulatory Affairs to ensure communication of critical process and technical information to meet required deadlines.
* Represent Lonza in customer‑facing meetings, audits and inspections, providing technical expertise.
* Ensure timely compilation of assessments of change requests and process validation related deviations.
* Review CMC sections in filing documents and technical content of validation reports; participate in continuous improvement initiatives and develop validation lifecycle strategies.
* Develop and implement standardized procedures and processes to drive harmonization and ensure compliance across the Mammalian network.
* Share information and knowledge across teams and functions; demonstrate high integrity.
Key Requirements
* Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines.
* Proven experience in managing complex projects.
* Minimum 1 year of experience in process validation within a cGMP‑regulated biopharmaceutical environment. Experience in process development, process scale‑up and/or manufacturing is a plus.
* Working experience in biopharma manufacturing and/or process development, preferably in Mammalian Manufacturing with strong understanding of upstream and downstream processes in mammalian cell culture.
* Good understanding of GMP.
* Excellent communication, technical writing, and stakeholder management skills.
* Fluency in English.
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, and the satisfaction that comes with making a meaningful difference.
Reference: R71895
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