Senior Validation Scientist

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Hillerød

Are you energized by using your knowledge to guide and mentor others to succeed? Do you thrive on solving complex equipment tasks such as optimisation, validation, and project planning of new facility initiatives? Would you like to be part of a highly skilled production unit dedicated to making a difference for people living with hemophilia? Then, apply today and join us for a life-changing career! The position As Senior Validation Scientist for API (Active Pharmaceutical Ingredient) you will be overall responsible for ensuring that our equipment and environment complies with GMP and ISO regulations as well as ensuring and managing optimisation of production equipment performance. You will do so by:
  • Setting the direction to ensure a risk-based approach to validation and maintaining the validated state of the equipment (incl. calibration and maintenance strategy approach)
  • Providing technical instruction and supervision of process engineers and technicians
  • Working closely with specialists and other stakeholders such as equipment, maintenance, and process supporters
  • Participating in inspections and audits by bringing in your expert knowledge
    • Qualifications On a personal level, you feel empowered by guiding and mentoring employees and making them succeed. You have role model behaviour and feel comfortable giving and receiving feedback in an open and respectful way that fosters personal growth. It is important to have strong analytical skills combined with an in-depth business knowledge. To succeed in this role, you have:
  • An engineering degreee, master's degree, or a PhD within natural science
  • Extensive and technical experience within the pharma industry and general experience with production and/or development of pharmaceutical products – preferably within API production/developement
  • Proven track record of validation/qualification experience in GMP manufacturing or CMC (Chemistry, Manufacturing and Controls) process development in the pharmaceutical, biotechnology or similar industry
  • Extensive experience in systematic problem solving
  • Fully proficient in both written and spoken English
    • About the department You will be part of a dynamic business area under Biotech and Rare Disease API Denmark, which produce Active Pharmaceutical Ingredients (API) for Haemophilia patients across the world. Our production unit consists of three departments: Facilities, Production and New Product Entry. You will be working closely with equipment responsibles and other stakeholders in the two other departments. The Facilities department consists of three teams: Equipment, Maintenance and Environment, which you will be supporting. We are situated in Hillerød and we currently produce Refixia® and Mim8 which are used to treat haemophilia patients. During the coming years we will embark on an exciting journey to include additional new products into our facility, thus becoming a multi-product facility. Working at BRD, Novo Nordisk Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2650 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career? Contact For further information, please contact Senior Manager of Facilities, Sabine Blicher Lerche Kruse at +45 3079 8443. Deadline 5th March 2023 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. Interviews will be held continuously during the application period. 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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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 13.10.2022, men kan have været deaktiveret og genaktiveret igen.

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