Process Validation Specialist

Social network you want to login/join with:

Description:

• Key responsibilities:

1. Design of the process validation strategy, preparation of validation documents (study design / writing protocols and reports) according to Lonza procedures and in compliance with regulatory mentorship.
2. Supporting R&D teams during the process characterization phase.
3. Reviewing and approving process characterization documents.
4. Responsibility for the validation assessment on changes and deviations (approval of deviations and changes).
5. Preparation and maintenance of a detailed continued process verification plan.
6. Assessing and approving Product Quality Reviews.

Key requirements:

• Master's degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or equivalent.
• Experience in project management, preferably in Operations, MSAT, Quality, and Compliance.
• Experience interacting with different collaborators within an organization and with regulatory agencies (Swissmedic, FDA, etc.) is an advantage.
• First experience in mammalian cell culture is an advantage.
• Ability to work on multiple tasks simultaneously and meet deadlines.
• Proficient communication skills in English (written and spoken); proficiency in German is appreciated.

Contact: Alba Jansa

WhatsApp: +41 76 811 63 99

Email: alba.jansa(at)