Process Validation Scientist
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.
We are currently looking for an experienced Process Validation Specialist to join our state of the art production facility in Geleen, in the south of the Netherlands.
You will have responsibility for your own projects, acting as the SME and representative on key Process Performance Qualification (PPQ) and Continued Process Validation (CPV) projects. Familiarity in the process to take a product to commercialisation is a must.
- 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
- MSc in Engineering or Life Sciences related topic
- Experienced in Process Performance Qualification (PPQ) protocols
- Experienced in Continued Process Validation (CPV)
- Ability to influence without direct reporting responsibility, working across different business functions.
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.