Cleaning Validation Expert
vor 2 Monaten
For our client Merck in Aubonne, we are currently looking for a âCleaning Validation Expertâ until the end of 2025.
The Cleaning validation within the Fill & Finish Department leads and manages all the cleaning validation activities within our site to ensure new production equipment and product implementation, the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.
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To evolve in this environment, we are looking for our next Cleaning Validation Expert (m/f/d) under a CDMAX contract until the end of 2025.Â
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Your role :Â
- Define and implement cleaning validation strategy in accordance with the guidelines defined on site and global level.
- Elaborate cleaning validation operational documentation required for the successful completion of cleaning validation activities (validation plan, protocols, reportsâ¦).
- Coordinate and execute cleaning validation activities and sampling in scope of the F&F department.
- Reference point for cleaning validation activities within the project team.
- Manage deviations, CAPA, Change Control within the scope of activity
- Ensure site readiness for Health Authoritiesâ inspection on Control Strategy and monitoring topics
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Who you are :Â
- Degree in Biotechnology, Process Engineering, Pharmacy
- Good knowledge of pharmaceuticals business, of regulatory pharmaceutical guidelines (cGMP) related issues and Health Authorities requirements
- Good experience in cleaning validation (3-6 years)
- Editorial quality (Procedures, risk analyses, deviations, etc.)
- Team spirit, leadership, autonomy, proactivity, and good communication are qualities necessary for success
- French mother tongue/fluent â Good level of English (minimum B2)
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