MSAT Process Validation Specialist
Vor 4 Tagen
Today, Lonza is a global leader in life sciences operating across five 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 site in Visp, Switzerland is growing and for our Biologics organization, we are currently looking for a MSAT Process Validation Specialist (80-100%). In this role, you will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs). Apply now and join this outstanding team
Key Responsibilities:- Design of the process validation strategy, preparation of validation documents (study design / writing protocols and reports) according to Lonza procedure and in compliance with regulatory mentorship.
- Supporting R&D teams during the process characterization phase. Reviewing and approving of process characterization documents.
- Responsibility for the validation assessment on changes and deviations (approval of deviation and changes).
- Preparation and maintenance of a detailed continued process verification plan.
- Assessing and approving of Product Quality Reviews.
- Master in Chemistry or equivalent experience, Biotechnology, Life Sciences or related field.
- Experience in project management, preferable in MSAT, Quality and Compliance.
- Experience in interaction with different collaborators within an organization and with regulatory agencies (Swiss medic, FDA etc.) would be an advantage.
- First experience in mammalian is an advantage.
- Ability to work on different tasks simultaneously and to work towards deadlines.
- Proficient communication in English (written and spoken), additional proficient communication in German is appreciated.
On top of being an equal opportunity employer and value diversity at our company, we offer great benefits and a comprehensive relocation package for eligible talents
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