Project Manager for Fill and Finish Expansion
7 days ago
Category: Project Management & Agile
Location: Lyngby, Capital Region of Denmark, DK
Do you want to be a part of developing the future Aseptic Processing facilities in a large global pharmaceutical company? Are you a Project Manager that thrives in technical areas within large scale programmes? If yes, then you might be the person we are looking for to support the design and implementation of technology solutions needed to drive the establishment of our new Aseptic Processing modules across the world.
The Position
As a Project Manager (PM) within Process Operation & Project Execution which is part of the Inspection and Material Handling department, you will play a key part in creating the future standards for an area that covers the last steps of aseptic processing. Our focus is inspection of filled-products with multi-format automated equipment, and changing existing processes that are mainly manual into fully automated solutions to handle incoming materials for the filling equipment.
Your responsibility will be to 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. This requires engaging with the Work Package Owners (WPO), Subject Matter Experts (SME), international stakeholders and harvesting the inherent experiences of the company and combining the input with state-of-the-art aseptic production technology.
As part of your work track, we expect the following content to be included:
- Project management of tasks within your work package including design of future technical solutions and process flows with focus on adherence to the aseptic standards and authority requirements.
- Preparing documentation and management of test execution and validation of activities within your area of responsibilities (FAT, SAT, IQ/OQ).
- Coordination with Quality Assurance (QA) and Regulatory Affairs (RA) and coordinating responsibility for designing and implementation of equipment.
- Design and implement training setup for inspection and other relevant compliance activities for the isolator filling line and related process.
- Coordination and alignment with local and global PM and WPO peers in an agile PM setup.
Qualifications
To be successful in this role, you should have the following:
- An academic degree within natural sciences, engineering or similar.
- Minimum 5 years of leadership and project management experience of technical or complex projects.
- Experience with driving design processes, validation, documentation for qualification and implementation of new equipment.
- Knowledge about aseptic process production design and GMP experience – ideally from the pharma industry would be considered as an asset.
- An excellent command of verbal and written English; command of Danish, French or Chinese in addition is a plus as some traveling to China, France, USA and within Denmark might be required.
As a person, you take initiative naturally and have a strong personal drive and dedication. You bring a good sense of humour to work even when pressure is on, and you thrive in a changing and dynamic environment. Demonstrating attention to detail and being structured in problem-solving approach are also important. Furthermore, you embrace professional and personal diversity.
About the department
The responsibility of AP Expansions is to plan and execute the establishment of new aseptic filling capacity across the global manufacturing network within BioTech and Rare Diseases (BRD) and Injectable Finished Products (IFP) for new filling platforms while ensuring harmonisation and global standards.
You will be joining Fill & Finish Expansions. The area is anchored in Product Supply, Quality & IT, which globally employ approximately 28,500 employees. Fill & Finish Expansions is a newly established and growing area with the responsibility to design, plan and build all 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. We are setting the standards for the future, designing facilities we will still be proud of many decades from now. Fill & Finish Expansions has a global approach, where you will be working with multiple sites and cultures across the world.
Contact
If you want to know more please reach out to Manager, Process Operation & Project Execution, Maja Christiansen on +4534483717 or get to know us better by visiting our career site here Novo Nordisk Global Manufacturing Careers.
Deadline
20 April 2025.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
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Kongens Lyngby, Lyngby-Tårbæk Kommune, Denmark Novo Nordisk AS Full timeCategory:Project Management & AgileDo you want to be a part of developing the future Aseptic Processing facilities in a large global pharmaceutical company? Are you a Project Manager that thrives in technical areas within large scale programmes? If yes, then you might be the person we are looking for to support the design and implementation of technology...
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