MSAT Process Validation Specialist

Lonza

Visp, Switzerland

The site in Visp, Switzerland is growing and for our Biologics organization, we are currently looking for a for 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.

Key requirements:

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.

Apply Now

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