You design and validate processes while supporting R&D teams. Your role includes reviewing documentation, managing changes, and ensuring product quality through detailed verification plans.
Anforderungen
- •Master in Chemistry or equivalent experience
- •Experience in project management, preferably in MSAT
- •Experience in interaction with regulatory agencies
- •First experience in mammalian is an advantage
- •Ability to work on different tasks simultaneously
- •Proficient communication in English and German
Deine Aufgaben
- •Design process validation strategies and documents.
- •Support R&D teams during process characterization.
- •Review and approve process characterization documents.
- •Validate assessments on changes and deviations.
- •Prepare and maintain a continued process verification plan.
- •Assess and approve Product Quality Reviews.
Deine Vorteile
Great benefits
Comprehensive relocation package
Original Beschreibung
# MSAT Process Validation Specialist (80-100%) (f/m/d)
**CH - Visp** | **Full time**
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).
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## 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.
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## 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.