Specialist in Aseptic Production

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Gentofte

Do you want to be a part of an aseptic production department with newly installed and implemented isolator technology in a large pharmaceutical company, and are you motivated by setting direction and continuous improvements? Are you considered an expert within the aseptic production processes including isolator filling technology? Does collaboration and teamwork across departments and production sites come naturally to you? If yes, then you might be the Specialist in Aseptic Production we are looking for. The position In this role you will be a key player in defining and setting direction for future aseptic processes in close collaboration with other specialists, process supporters, and manufacturing development team. You will play a large role in ensuring that the Filling solution is well documented and implemented so we are able to deliver on required business demands. Consequently, you will be part of ensuring that relevant requirements are fulfilled, and the processes are supporting making quality easy during daily operation. You will be expected to use your previous Isolator Filling experience working within the line of business on various tasks, both within a project and production framework. The key tasks will include:
  • Using your specialist knowledge in continuously developing technical solutions to always keep the aseptic process up to date.
  • Development of process flow with focus on designing flow and processes according to the aseptic standards and authority requirements.
  • Participation in troubleshooting and support in general and to deviation handling
  • Providing guidance to e.g. process supporters in isolator filling and aseptic behavior when needed.
  • Support training setup for operations with focus on a high reliability manufacturing.
  • Setting the direction to ensure a risk-based approach to ensure and maintaining the validated state of the equipment, including e.g. calibration and maintenance strategy approach.
    • You will be a key player in critical cases, and by using the thorough aseptic filling process knowledge find appropriate solutions, as well as in continuous improvements within filling processes and more. Qualifications To be successful in this role you need to have:
  • An academic degree background within the natural science or engineering areas.
  • +5 years of work experience within aseptic filling in a GMP environment, preferrable around Isolator Filling technology.
  • Significant experience from the pharma industry or other regulated industry where GMP (Good Manufacturing Practices) and similar requirements exist.
  • Significant experience from filling production, including working with validation documentation and regulatory requirements.
  • A quality mindset and a drive to create the “right” solutions while challenging the status quo.
  • Full proficiency in English, verbal and written.
    •   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. You possess great communication and interpersonal skills as these are essential tools on your road to success, with especial focus on the ability to building relations with stakeholders. About the department BRD Finished Products in Gentofte is part of Novo Nordisk, which delivers products for the treatment of haemophilia disorders. Our department will handle aseptic filling on brand new isolator filling lines. Currently, the department is heavily involved in project activities related to the new isolator filling lines, and in the short run, the specialist tasks will be related to a successful ramp-up towards production start-up.We are currently approximately 70 motivated and talented colleagues. Your department is especially characterized by being newly established, high professionalism, and an informal tone. The department have close collaborations with the other departments within the area which can increase the complexity. BRD Product Supply is multi-cultural, so English is widely spoken. We guarantee that you will be exposed to exciting professional challenges and development opportunities.    Working at 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 to people living with serious chronic diseases, but we also use our competences in biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are more than 3000 dedicated colleagues working at six production sites in Denmark and the United States. Here we cover the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. As more and more people need our products, we support Novo Nordisk's initiatives in new therapy areas. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology.   Contact For further information please contact Anne Holm Andersen at: +45 3448 3149.
      Deadline 17 March 2024. We will process applications as we receive them, so do not hesitate to apply as soon as possible. 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.  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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    Arbejdsstedet er beliggende i Gentofte.

    Jobbet er oprettet på vores service den 14.11.2023, men kan have været deaktiveret og genaktiveret igen.

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