* 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.
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.
* 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.