Are your analytical skills strong and do you enjoy a hands-on approach to your field? Can you add to the success story of Novo Nordisk and ensure the highest level of quality in the production of life-changing medicine to biopharmaceutical products worldwide? And would you like a range of opportunities for personal and professional development? Then you might be the next member of our dedicated support team. About the department In Biopharm, we produce a range of products that help people live with chronical diseases like haemophilia and hormonal imbalances. In our new filling and inspection facility, we will be filling the Active Pharmaceutical Ingredients (API) onto vials and dosage systems. In other words, we make the products ready for packing and distribution with all the processes that are involved in this – from various visual inspections over actual filling procedures to all the documentation that is necessary for us to comply with regulatory and quality standards. Our filling and inspection facility is ready to enter the next phase, and now we are looking into a period of production ramp up, which in turn initiates many process optimisation projects. You will be part of a support team of dedicated and talented academics and technicians. Our tone is relaxed, and if you enjoy sharing your knowledge and learning from others, you will enjoy working here. The facility is located at our site in Kalundborg with approximately 350 employees. The position As process supporter, your primary goal is to ensure that the production consistently delivers a high-quality product in compliance with internal quality requirements and GMP. Our team supports the production on shop floor, and our field of responsibility for the filling processes covers the validation of the lines, the operational procedures to operate them, the expertise in the products and the continuous improvement of the filling lines. This means that whenever something is out of the ordinary, we are the ones who help make everything run again as quickly as possible. When something needs changing, we ensure that the right validation procedures are in place, challenging external vendors on specifications and technical issues when necessary. The main role in this position is PAS-X support. As a PAS-X supporter you support your colleagues in problem-solving, corrections to Batch Records, data collection and identifying improvements to the Master Batch Records (MBR). You participate in projects to ensure timely impact assessment to MBR. Training of both end-users and other supporters is an essential part of the role.
As the responsible for Generic Master Batch Records (GMBR) you drive changes from the initial Change Request through design and verification phases. This includes designing in PAS-X, Design Qualification and Verification activities in accordance with Science- and Risk- based Validation. As part of the MBR design role you will be configuring PAS-X Master Data and updating Functional Specifications. Verification activities are documented in TIMS.
The PAS-X solution is integrated to the filling line through SCADA and interfaced to SAP. You are expected to have knowledge of this data integration and participate in problem solving. The PAS-X related hardware, barcode scanners, printers and hand-held devices must be maintained. In the ARSU role (Area Responsibe Super User) you will act as an experienced super-user having deep knowledge within Aseptic Production and be the representative for Line of Business towards the global network of other production ARSUs, ARSU chairs and Global IT teams and relay information in both directions, including down-time schedules and request. Be the local champion for the Intended Use SOP and own intended use production execution KPIs and ensure alignment with local procedures and user guides. You will actively participate in global production ARSU forum meetings as well as Site Specific Problem Solving meetings. Escalate issues through the right channels and follow up on support tickets raised in ServiceNow. To ensure data exchange between SAP and MES and to take action in case of failed IDOCs. You will be handling a range of stakeholders with diverse and possibly conflicting needs and concerns in a way that ensures the optimal collaboration across professional and cultural distances – and has the continuation of a stabile production chain as a result. You will be taking part in systematic problem solving processes, development- and optimisation projects and develop a broad understanding of a complex value chain, when you provide our collective expertise across a truly global organisation. Furthermore, when you are ready, you will support the development of competencies in our production team and participate in audits and inspections. Qualifications

You hold a degree in bio chemistry, bioengineering, automation engineering, or similar.

Preferably, you have 2+ years of experience from the pharmaceutical industry after graduating, and have knowledge about aseptic production and behaviour as well as current knowledge in process automation in biotech.

You are fluent in both Danish and English and have great interest in working with GMP and LEAN.

As a person, you are open and honest, independent as well as team player and flexible to changes.

You have good communication skills and the ability to efficiently work with concurrent tasks. Being proactive, responsible and energetic is a key to succeed in this position. In return, you will find opportunities for personal and professional development here that will be hard to come by elsewhere.

Working at Novo Nordisk At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to help us strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us and make the most of your talent. Contact Should you wish to learn more about what it is like working in Novo Nordisk, here is a good place to begin: https://www.novonordisk.com/careers/working-at-novo-nordisk.html
For further information about the position, please feel free to call Julio Santiago, 34 48 06 96.
Deadline 31 July 2023. 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.