Cleaning Validation Specialist
vor 1 Monat
Our client Merck in Aubonne is seeking 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, business continuity, and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration, and GMP requirements.
Your Role:- Define and implement a cleaning validation strategy in accordance with the guidelines defined onsite and global level.
- Develop and maintain 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.
- Be a reference point for cleaning validation activities within the project team.
- Manage deviations, CAPA, and Change Control within the scope of activity.
- Ensure site readiness for Health Authorities' inspection on Control Strategy and monitoring topics.
- Degree in Biotechnology, Process Engineering, or Pharmacy.
- Good knowledge of pharmaceutical business, 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 necessary qualities for success.
- French mother tongue/fluent – Good level of English (minimum B2).
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