Process Validation Specialist
Swisslinx
- 4/30/2025
- 95%
- Position with responsibilities
- Temporary
We are looking for a Process Validation Specialist to design validation strategies and prepare documentation (study design, protocols, and reports) in line with procedures and regulatory guidelines.
Process Validation Specialist
Job description:
- 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.