Process Validation Specialist – 6484 URA

Our client, a global market leader in the production and process to support a broad range of customers – from emerging biotech’s to global pharmaceutical companies – to transform their therapeutic discoveries into life-saving and life-enhancing treatments for their patients, is looking for a Process Validation Specialist on a contract basis until the end of the year based in the Valais area, Switzerland.

Main Responsibilities:

• Design of the process validation strategy, preparation of validation documents (study design / writing protocols and reports) according to Companies 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.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• Master’s in chemistry, Biology, Biotechnology, chemical engineering or equivalent.
• Experience in project management, preferably 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.
• Proficient communication in English (written and spoken), additional proficient communication in German is appreciated.