346 jobs in Saint-Prex found

For our client Merck in Aubonne, we are currently looking for a 'Cleaning Validation Expert' 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.

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. 

Your role : 

• 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, reports...).
• 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 Authorities' inspection on Control Strategy and monitoring topics

Who you are : 

• 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 - Good level of English (minimum B2)