Process Validation Scientist (m/f/d)

Key responsibilities

• Design of the process validation strategy, preparation of validation documents (study design / writing protocols and reports)
• 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, Biology, Biotechnology, chemical engineering or equivalent.
• Experience in project management, preferable in Operations, 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.