Process Validation Specialist
Visp
Contract
Negotiable
Quality
CR/543534_1747128173
Process Validation Specialist
We have a current opportunity for a Process Validation Specialist on a contract basis. The position will be based Kanton Wallis. For further information about this position please apply.
Key responsibilities:
- Design of the process validation strategy, preparation of validation documents (study design / writing protocols and reports) according to Lonza procedure and in compliance with regulatory mentorship
- Supporting R&D teams during the process characterisation phase
- Reviewing and approving of process characterisation 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
Key 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 organisation 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
For further information about this position, please apply with your CV.
**Please note, only candidates who are authorised to work in Switzerland (e.g., Swiss nationals, EU/EFTA citizens, or individuals with a valid work permit) will be considered for this position.**