Clean Utility Operations Specialist

5 days ago


Kongens Lyngby, Lyngby-Tårbæk Kommune, Denmark Novo Nordisk AS Full time

**About the Job**

You will have the opportunity to make a real difference in the lives of millions of patients worldwide by joining our team as a Clean Utility Operations Specialist. In this role, you will define and implement design and operating principles across global Fill & Finish sites, collaborating with internal and external stakeholders.

The focus is on design and implementation of clean utility systems, bringing knowledge and innovation to the team. You will drive projects from conception to completion, ensuring they meet quality and timeline requirements.

This position offers the opportunity to travel to our global sites located in various countries. In this role, you can look forward to up to 20% of travelling activities.

Key Responsibilities
  • Managing tasks within the assigned work package, including designing solutions.
  • Collaboration with global fill & finish sites and sub-suppliers to ensure secure collaboration.
  • Coordination with a global engineering partner to deliver local aseptic standards and authority requirements within equipment design and implementation.
  • Planning and participating in global workshops and supplier supervision, as well as supporting Factory Acceptance Test (FAT), Site Acceptance Testing (SAT), and commissioning.
  • Planning handover activities, such as Performance verification (PfV) and maintenance of utility equipment and control in collaboration with global fill & finish sites.
Requirements

To be successful in this role, you must have:

  1. A bachelor's degree, a master's degree or a PhD in mechanical engineering, chemical engineering, natural science, or similar fields.
  2. At least 5 years of experience in designing, maintaining, and validating Clean Utility in a GMP environment.
  3. Familiarity with SRV validation concept and project execution experience in production/aseptic production for the pharmaceutical, biotechnology, or similar industry.
  4. Knowledge or interest in exploring and driving new technologies.
  5. Full professional proficiency in written and spoken English.

You are an ambitious and driven individual who thrives in a dynamic international environment. You enjoy building great relationships with key stakeholders and are passionate about delivering high-quality results.



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