MSAT Validation Specialist Role Overview
The role of MSAT Process Validation Specialist is a key position within the Bioconjugates organization at our site in Visp, Switzerland. As a member of this team, you will be responsible for manufacturing process validation in biopharmaceutical plants, including process characterization, validation activities at scale, and Product Quality Reviews (PQRs).
This position involves preparing validation documents according to Lonza procedure and regulatory guidance, owning the process validation, and communicating with customers. Additionally, you will review and approve process characterization documents, assess changes and deviations, prepare and maintain continued process verification plans, and author, assess, and approve PQRs.
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Key Responsibilities
* Validation Document Preparation: Prepare validation documents (study design/writing protocols and reports) according to Lonza procedure and in compliance with regulatory guidance.
* Process Validation Ownership: Own the process validation including communication with customers.
* Document Review and Approval: Review and approving of process characterization documents.
* Change and Deviation Assessment: Responsible for the validation assessment on changes and deviations (approval of deviation and changes).
* Continued Process Verification: Prepare and maintain a documented continued process verification plan.
* PQR Management: Authoring, assessing, and approving of PQRs
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Requirements
* Educational Background: Master or Ph.D in Chemistry, Biotechnology, Life Sciences, or related field, or equivalent experience.
* Experience: Experience in project management, preferable in MSAT, Operation, Quality, and Compliance.
* Team Collaboration: Experience in interaction with different teams within an organization and with regulatory agencies would be an advantage.
* Task Management: Ability to work on different tasks simultaneously and in a timely manner.
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About Us
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