Process Assessment and Validation Scientist III
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.
For our MSAT department in Geleen we are hiring a Process Assessment & Validation Scientist III. As Process Assessment & Validation Scientist III you are in charge of executing process assessment and validation activities in joint collaboration with the client with high level of independency. You will Provide technical know-how on GMP and aseptic manufacturing to the process development team. You will also providing guidance to the junior member of the team.
- Drives completion of process assessment and validation activities as per agreed timeline in close collaboration with internal and external parties
- Executes proper assessment on all process related areas including but not limited to the process, APS, facility, equipment and materials from GMP point of view, identifying the risks and suggesting appropriate mitigation strategies.
- Drives process performance data trending during TT and post- TT, assessing the process performance and provides suggestions for process improvement
- Actively participates in troubleshooting and serves as investigation lead for process impacting deviations and investigations.
- Provides technical guidance on change controls and how they might impact customer processes.
- Provides supervision and technical guidance to the junior members of the team
- Ensures and encourages an Operational Excellence environment
- Develops and report metrics for clients to trend project progress in collaboration with PM
- Keeps current with advances in cell and gene therapy field
- Strongly collaborates with process transfer manager on improving the performance of the team
- The position requires extensive knowledge in the field of process validation, cell and gene therapy and applicable technologies, GMP and aseptic manufacturing, risk mitigation
- The position requires solid experience in interacting and collaborating with the clients and internal parties, including professional communication and transparency
- The position involves in training of junior members of team on their daily tasks
- This function requires solid knowledge and adherence to ATMP specific regulations
- This function must perform independently in the area of responsibility and is responsible for ensuring in time delivery of deliverables assigned to.
- This position requires experience in working in a fast pace environment and demonstrating professional response to unexpected events.
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.