MSAT Process Validation Expert
vor 3 Wochen
At Lonza, we're seeking a talented MSAT Process Validation Specialist to join our Biologics organization in Visp, Switzerland. As a key member of our team, you'll be responsible for manufacturing process validation in our biopharmaceutical plants. This includes process characterization, validation activities at scale, continued process verification, and Product Quality Reviews (PQRs).
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 guidance.
- 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 documented continued process verification plan.
- Assessing and approving of Product Quality Reviews.
Key Requirements:
- Master in Chemistry, Biotechnology, Life Sciences or related field.
- Min. 2 years experience in project management, preferable in MSAT, Quality and Compliance.
- Experience in interaction with different stakeholders within an organization and with regulatory agencies (Swissmedic, 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.
- Fluent communication in English (written and spoken), additional fluent communication in German is appreciated.
Join us at Lonza, where we're dedicated to improving lives through science. Our products and services have a positive impact on millions of people worldwide, and we're committed to making a meaningful difference in the world. If you're passionate about life sciences and want to be part of a dynamic team, we encourage you to apply for this exciting opportunity.
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