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Process Validation Specialist
vor 6 Stunden
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.
The Process Validation Specialist is responsible for defining the validation strategy and executing process validation activities to support the implementation of commercial manufacturing processes at Lonza Visp. The Process Validation Specialist also reviews the validation status as part of continued process performance verification. Additionally, the role includes assessing the validation impact of deviations and change request in commercial projects.
Key responsibilities:
- Process Validation: Develops, executes, and documents validation protocols; ensures ongoing CPV/PQR.
- Deviation & Change Control: Manages deviations and change controls per compliance standards.
- Customer Collaboration: Represents validation in projects; liaises with customer technical/quality teams.
- Audit Support: Serves as validation representative in audits and inspections.
- Training & Compliance: Follows training, policies, and cGMP; applies ICH, FDA, EMA, PIC guidance.
- Mentoring: Supports colleagues through knowledge sharing and technical advice.
Key requirements:
- PhD or Master`s Degree in Chemistry or an related field
- Experience in process manufacturing, in GMP environment is preferred
- Ability working within a virtual team and managing the collaboration of different departments
- Fluent language skills in English are required
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.
