Project Lead for Aseptic Processing

4 days ago


Kongens Lyngby, Lyngby-Tårbæk Kommune, Denmark Novo Nordisk Full time
About the Role

As a Project Manager within our Aseptic Processing team, you will play a key part in creating the future standards for an area that covers the last steps of aseptic processing, inspecting our filled-products with multi-format automated equipment, but also changing existing processes that are mainly manual into fully automated, among others, to handle incoming materials for the filling equipment.

Key Responsibilities
  • Drive defined technical projects within your designated area, while supporting the overall project goals of delivering a world-class solution in a time frame that challenges the traditional approach.
  • Prepare documentation and manage test execution and validation of activities within your area of responsibilities (FAT, SAT, IQ/OQ).
  • Coordinate with Quality Assurance (QA) and Regulatory Affairs (RA) and design and implement equipment.
  • Design and implement training setups for inspection and other relevant compliance activities for the isolator filling line and related process.
  • Coordinate and align with local and global PM and WPO peers in an agile PM setup.
Requirements
  • Academic degree within natural sciences, engineering, or similar.
  • From 3 to 5 years of relevant experience in project management.
  • Project management experience of technical or complex projects.
  • Experience with aseptic process production design and GMP experience – ideally from the pharma industry.
  • Experience with driving design processes, documentation for qualification and implementation of new equipment.
  • A quality mindset and a drive to create the 'right' solutions while challenging the status quo supported with data.
  • An excellent command of verbal and written English.
About Us

We are Fill & Finish Expansions, a newly established and growing area within Product Supply, Quality & IT, with a global approach to design, plan, and build major fill & finish expansion projects across PSQIT to serve the needs of millions of patients. We do it by rethinking our fill & finish facilities with the use of modern technology.



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