Process Supporter for Cultivation Processes – iAgora Europa – null

Descripción del puesto:We are looking for a process supporter who would like to be part of a highly skilled production unit dedicated to making a difference for people living with Haemophilia and other chronic deseases. About the department You will be part of a dynamic business area which produces Active Pharmaceutical Ingredients (API) for patients across the world. The open position is in dep. 7321 New Product Entry, Biotech and Rare Diseases (BRD) API and is located in Hillerød. The department is responsible for transferring new products from Development to the production facilities in Hillerød, which includes both phase 3 production as well as process validation. The department is part of a larger production area with other departments such as production, equipment, maintenance, calibration and IT/Automization.The Job You will be a part of the Product Transfer team responsible for New Product Entry which currently consists of ca. 8 highly dedicated and skilled colleagues. As a process supporter in New Product Entry your key responsibility is to ensure the implementation of new mammalian cultivation processes in the existing production facility together with your colleagues from production. These tasks include process, technology and knowledge transfer from our colleagues in development as well as writing procedures, process documents, protocols and change requests. Up to the first campaigns you will also be responsible for ensuring correct training and knowledge transfer to operators and process supporters in current production and will play a crucial role in supporting the running production. We expect you to have a keen eye for detail, a nag for analysing process data from development and production, a good understanding of production processes as well as a strong GMP mindset and stakeholder management. Your key responsibilities will be: * Coordination of activities with internal and external stakeholders (process development, equipment, facility, production, automization and QA) * Responsible for preparing and supporting campaigns for new products, including required documentation in accordance with the current standards and legislations, change requests and process deviations * Ensure technology, process and knowledge transfer between development and production * Troubleshooting related to the daily manufacturing of new products * Initiate problem solving (A3 or similar) for observed process deviations or other issues in the production of the new products Qualifications * You have an education as bioengineer, biotechnologist, biochemist or similar and have a minimum of 2 years of experience with production and/or development of pharmaceutical products. Preferably you have experience in mammalian cell cultivation or fermentation under GMP with changing products. * As a person, you have strong analytical skills and preferably with solid knowledge of cell cultivation processes. * You are structured and proactive in your work, good to work independently, make data based decisions which both are within our GMP frame as well as support our strategic goals. LEAN is a natural part of your skill set. * You will have several stakeholders across the organization and therefore your written and spoken communication skills in both Danish and English must be excellent. * To succeed you need to be able to keep a cool head and make decisions in a busy work environment where the agenda changes frequently. Contact For further information please contact Christiane Wiendahl at +45 30 79 48 62. Deadline 15 jun 2022, but apply now sooner than later, as we look at candidates on an ongoing basis. 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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