Filling Specialist

Do you want to be a part of the development of the future Aseptic Processing facilities in a large global pharmaceutical company? Are you motivated by implementing and validating new technologies in the Filling process of Fill Finish Expansions? Does global collaboration and teamwork across cultures come naturally to you?
If yes, then you might be the Filling Specialist we are looking. Apply now!

The Position
As a Filling Specialist you will be a key player in defining and specifying technical requirements under the filling process, along with testing and validation aspects. You will be engaged together with our Central Manufacturing Development team, Senior Project Managers, other specialists, and Subject Matter Experts in the Fill Finish Expansions program locally and across global sites.
You will play a large role in ensuring that the Filling solution is well documented and implemented to deliver the business impact. You will be expected to use your previous Filling line experience working within the Filling Work package on various technical tracks within the project framework. The filling work package is responsible for delivering solutions designed for minimal human interventions and of the highest compliance. The work package also has the mandate to check the progress of machine construction via oversight activities at supplier site thus leading up to managing successful FAT and subsequent SAT-IQ-OQ phases in our production floors globally.

The key tasks will include: • Using your specialist knowledge in developing technical solutions in various sub-projects running in the filling work package.
• Development of future process flow with focus on designing flow and processes according to the aseptic standards and authority requirements.
• Being a key player in vendor oversight during the equipment design, build and test phases thus leading up to participation in Factory Acceptance Tests (FAT).
• Providing guidance in the creation of test protocols and reviewing them for the respective FAT, SAT, IQ/OQ and further CQV phases.
• Setting the direction to ensure a risk-based approach to validation and maintaining the validated state of the equipment (including calibration and maintenance strategy approach). Furthermore, you will contribute to the training setup for operations, with focus on a high reliability manufacturing. Finally, you will support standardization of filling lines including sub-systems and leveraging throughout the qualification stages.
Qualifications
To be successful in this role you need to have:
• A background within the natural science or engineering area
• +10 years of work experience within aseptic filling operations, that caters around Filling technology. Work experience around introduction of new technologies and filling processes would be an advantage.
• Experience from the pharma industry or significant experience with filling lines in other regulated industry where GMP (Good Manufacturing Practices) and similar requirements exist.
• A quality mindset and a drive to create the “right” solutions while challenging the status quo.
• An excellent command of verbal and written English.
• Subject matter expertise within technical areas such as filter integrity testing (PUPSIT) and Single use systems would be a strong advantage but not a requirement.
• Knowledge within other areas such as sensor filling, stop flush and electronic manufacturing execution system (Pas-X) etc. would also be valuable but not required. As a person you are comfortable with taking initiative and have a strong personal drive and dedication. You bring a good sense of humor to work even when pressure is on, and you thrive in a changing and dynamic environment. You demonstrate attention to detail, and you are structured in your problem-solving approach. Furthermore, you embrace professional and personal diversity. About the Department Our department Technology Standards is situated in the newly created SVP area of Fill & Finish Expansions. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 27,000 of [xxxxx]’s +70,000 employees.
Fill & Finish Expansions is a newly established and growing area with the responsibility to design, plan and built all new aseptic filling capacity across Novo Nordisk to serve needs of millions of patients. We do it by rethinking our aseptic production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. Fill & Finish Expansions has a clear global approach, where you will be working with multiple sites and cultures across the world. To learn more about Fill & Finish Expansions in Novo Nordisk visit our career site here: Let's build the future for patients: Exciting Careers in Growing Expansion Project (novonordisk.com)

Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact For further information please contact Rasmus Krøger Hare at: +[xxxxx].

Deadline 2 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. To ensure an efficient and fair recruit-ment process, please refrain from adding a photo to your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] 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.