Equipment & Validation Scientist

The position

As a scientist/engineer in the Virology and Cell Banks department your job will include different tasks with focus on equipment validation and project management. The main responsibility will be to ensure that the equipment is ready for production and live up to the pharmaceutical industry’s (GMP) requirements. This includes qualification/validation activities, service and maintenance tasks related to the cell bank productions.Moreover, you will: Manage and drive projects concerning implementation and qualification of new GMP equipment in the production environment. This responsibility can be expanded to include equipment for laboratories (virology). Handle deviations, change requests related to existing equipment, as well as small or medium-sized validation, and verification projects. Interact with stakeholders in connection with technology projects. The equipment in scope ranges from simple to major production equipment and systems for monitoring of temperature and pressure. The equipment is both simple laboratory equipment to more complex filling equipment and IT based systems. Because the equipment is used to produce and maintain the inoculation material for Novo Nordisk products, you will be involved in audits and inspections as well as questions from the Health Authorities. In addition, you will be responsible for identifying opportunities for improving processes and compliance in relation to equipment and facilities. Qualifications Our ideal candidate holds a degree within engineering/technology. Ideally, you gained experience in operation, maintenance, and qualification/validation of equipment in a GMP-regulated environment, and you have an interest in project management. Additionally, we are looking for someone who: can drive multiple projects with multiple stakeholders at the same time. is experienced in validation/verification of equipment for use in GMP settings. have a strong quality mindset. thrive in an environment with many different tasks in a broad range of areas within the scope of the department. have an analytical mindset, and can create solutions when standards are challenged, although always with respect for the cGMP requirements. is strong in writing documents of adequate quality and feel comfortable in presenting our work for national and international inspectors. we expect you to be able to plan, execute, and report assignments independently, and work in cooperation with your team colleagues. On a personal level, we are looking for someone enthusiastic, committed, and self-motivated, who possess excellent cooperation and communication skills, as the ability to interact with colleagues at various organizational levels. You encourage diversity, was an inclusive mind-set and always treats other people with respect. You bring a can-do attitude and have the motivation for taking on new challenges and you are a strong team player. About the department As part of Novo Nordisk PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. We develop, manufacture and distribute drug candidates for clinical trials and have a strong culture with a “can do” mind-set. The Microbial Cell Bank team is located within the Virology & Cell Banks department in CMC API Process operations. Virology & Cell Banks, contributes to CMC API Process operations by manufacturing and maintaining cell banks from FHD until a product is removed from the market. Additionally, we ensure the virus safety of raw materials, cell banks, and the active pharmaceutical ingredient (API) for products in Novo Nordisk's development portfolio. We accomplish this through a combination of virus clearance evaluations and virus analyses. We adhere to applicable GxP requirements. The department is known for engaging an innovative mindset when optimizing our processes.The Cell Bank teams are located on two locations, Bagsværd (Microbial) and Hillerød (Mammalian), Denmark. The rest of the department is split into two teams located in Gentofte and work within virology. This job will be anchored in Bagsværd, but with a possibility for breaching into the other cell bank team and the virology teams as will at times. 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, employees. Together, we go further. Together, we’re life changing.