Cleaning Validation Expert Cdmax

Vor 6 Tagen

Aubonne, Schweiz Merck Group Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

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)

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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