Validation Expert

vor 2 Monaten

Aubonne VD, Waadt, Schweiz Merck (Schweiz) AG 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 MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within Merck BioPharma Aubonne site to ensure the supply of New Biologic Entities (NBEs) and 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 Validation Expert (m/f/d).

Your role :

  • To ensure the deployment of the Process Control Strategy on the Fill&Finish department for all manufacturing processes according to Good Manufacturing Practices and Company's Quality Standards
  • To ensure the continuous reporting for monitoring activities for all manufacturing processes according to Good Manufacturing Practices and Company's Quality Standards
  • To maintain all actions related to the control strategy and monitoring within the expected timelines
  • To ensure site readiness for Health Authorities' inspection on Control Strategy and monitoring topics

Who you are :

  • Degree in Biotechnology, Process Engineering, Pharmacy, statistics or related subject.
  • Good knowledge of pharmaceuticals business, of regulatory pharmaceutical guidelines (cGMP) related issues and Health Authorities requirements
  • Good knowledge of F&F processes/unit operations
  • Experience in international pharmaceutical companies with a fluency in english and french
  • Strong interpersonal skills and ability to interact positively and constructively with all functions in matrix organization environment.
  • Strong expertise in statistical analysis with a good knowledge of main analytical techniques and their application for panel testing

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

Apply now and become a part of our diverse team

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