Sterility Assurance Expert

vor 1 Woche

Aubonne, Schweiz Merck KGaA Darmstadt Germany 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.

**Your Role**:

- Being accountable for Sterility Assurance on site in line with new annex 1 requirements and all regulations related to sterile manufacturing and aseptic practices.
- Be the site expert and the main contact in front of Health Authorities.
- Ensure that requirements and processes are aligned with best industry practices and industry trends.
- Ensure that from an aseptic perspective, the manufacturing operation runs following its validated status, all SOPs, and Good Manufacturing Practices.
- Bring expertise in Sterility Assurance on cross-functional strategic projects and topics.
- Responsible for elaboration of Contamination Control Strategy in collaboration with Production aseptic operations and Microbiology/Environmental monitoring laboratory.
- Acts as a lead expert towards the other Departments: Production, QA, QC, Technical Services
- Collaborate closely with Bari and other sites producing sterile product as part of the community of practice
- Participate in manufacturing investigations including product impact assessments for potential aseptic practices issues or concerns.
- Maintain knowledge to be the site SME and guide appropriate direction in training programs for aseptic practices.

**Who you are**:

- 8 to 10 years of microbiology / sterility assurance or aseptic filling experience in the pharmaceutical or biotechnology industry
- Bachelor's degree as minimum qualification
- Solid experience in Good Manufacturing Practice (cGMP)
- Fluent in French and English
- Highly collaborative, results oriented and with excellent interpersonal communication skills

**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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