Aseptic Process Expert

Do you have expertise within aseptic production operational process? Are you looking to offer your experience within the development of the future Aseptic Processing standards? Are you looking for a global position where you can drive the development and implementation of a new, digital initiative defining a global standard for GMP compliance and data capturing?

If so, then you might be the right aseptic process Subject Matter Expert (SME) that we are looking for to continue our digital transformation journey. Read on to find out more! The Position As the newly appointed Aseptic process SME, you will play a crucial role by setting the aseptic operational directions in establishing the future global standard for the Digital Material Traceability (DMT) solution. This solution aims to effectively track, monitor, and validate the compliance of all assets utilized during production, thereby setting a new benchmark for simplifying aseptic operational process and data quality. Furthermore, this initiative will serve as a steppingstone towards realizing the "lights-out" ambition for the facilities of the future. You will be at the core of ensuring the best possible design, delivering a solution we can still be proud of in 20 years.
The main tasks will be to:
• Defining one of the main pillars of DMT by integrating your process knowledge into the final solution
• It will be your overall responsibility to ensure that the gap between the current and the to-be processes is well-known, and that the solution is built upon feasible process requirements and to-be processes.
• Examples of specific tasks: Heading up validation activities, process alignment across of packages, defining/validating to-be processes, and supporting the compatibility testing of the chosen technology. In this position, you will work in collaboration with a wide network of stakeholders on a local and global level. This will include the DMT Work Package Owner (WPO), Subject Matter Experts across IT, Process and Technology, suppliers, local sites end users and our Central Manufacturing Development team. This gives you the opportunity to travel to our global sites and visit suppliers which includes sites based in Denmark, France, US and China. 20% travel is expected for the position.
Qualifications The following are the preferred qualifications for the candidate applying for this role: • An academic background within engineering/ chemistry/ biotechnology/ pharmacy.
• +5 years of experiences within aseptic production, pharma production, GMP environment or biotechnology. W&S process experience within Novo Nordisk is an absolute bonus.
• Hands-on experience with production, problem solving, and validation activities.
• A strong interest in exploring and driving new technologies, and a willingness to challenge the status quo.
• Able to navigate uncertainty, and to make decisions with only limited information available.
• Excellent stakeholder management skills and experience working cross-functionally with various cultures, job functions, and experience levels.
• Full proficiency in English. As you will be working globally with the Danish sites, US, Brazil, France and China, language skills within these areas would be advantageous. As a person, you are focused on quality, as well as deliverables and have the drive to create new solutions. Your forward-thinking and visionary outlook allow you to anticipate future trends and promote process optimization and digitalization alongside your colleagues. With your global citizen mentality, you are a collaborator at heart and work seamlessly with your colleagues to deliver exceptional outcomes that meet and exceed expectations, requiring excellent communication skills to build trusted relationships cross functionally and globally. About the Department Technology Standards is a department in the newly created area of Fill & Finish Expansions. Fill & Finish Expansions is anchored in Product Supply, which globally accounts for +19,000 of Novo Nordisk’s +50,000 employees. The responsibility of Fill & Finish Expansions is to plan and execute the establishment of new aseptic filling capacity across the global manufacturing network. Including BioTech and Rare Diseases (BRD) and Injectable Finished Products (IFP) for new filling platforms while ensuring harmonisation and global standards. Across the different roles there is a distinct global aspect as the end goal is a global standard and best practice, and working with multiple sites, cultures and traditions will be a key element.
Across the different roles there is a distinct global aspect as the end goal is a global standard and best practice, and working with multiple sites, cultures and traditions will be a key element. Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact If you want to learn more about the position, Senior Manager Formulation and W&S Bo Hove Vanting Andersen on +45 30790408. Deadline 12 February, 2024. 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. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your 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.