As part of the reliability of information systems for our pharmaceutical client, we are looking for a CSV Engineer.
Key responsibilities:
- Define validation strategy by reviewing and approving validation plans and reports
- Review and approve description of technical changes
- Review and approve IQ / OQ / PQ protocols and reports
- Analyze SOPs and models specific to CSVs
- Ensure the proper execution of qualification and validation regarding the client’s validation methodology.
Qualifications & Technical Knowledge:
- You have an engineering degree or a specialized Master in Industrial Informatics, Pharmaceutical Sciences or equivalent
- You have a first relevant experience on computerized systems
- You know the GMP environment and the specific regulations applied to computerized systems (e.g. GAMP, CFR, Eudralex…)
- You are a team player, resistant to stress, rigorous and precise
- You speak French and are able to work in English
- You are mobile to work and live permanently in Belgium.