Process Validation Specialist

For our biopharmaceutical partner, Gi Life Sciences is looking for a :

Process Validation Specialist

(Temporary Contract – 6 months)

Your 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

Your profile:

• Master in Chemistry, Biology, Biotechnology, chemical engineering or equivalent
• Experience in project management, preferable in Operations, MSAT, Quality and Compliance
• Experience in interaction with regulatory agencies (Swiss medic, FDA etc.) would be an advantage
• First experience in mammalian is an advantage
• Languages: English. German is an asset

Your contact at Gi Group : Anaïs Mieszczak