SME - Isolator Filling

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Nordsjælland

Do you want to be a part of the development of the future Aseptic Processing facilities in a large global pharmaceutical company and are you motivated by implementing and validating these technologies? Are you considered an expert within the aseptic production processes including isolator filling technology? Does global collaboration and teamwork across cultures come naturally to you? Then you might be the SME-Isolator Filling we are looking for to develop and support implementation of the technology solutions needed to drive the establishment of our new aseptic production lines. The position
As an SME you will be a key player in specifying and defining the Filling solution, together with line of business, the Senior Project Manager and Specialist responsible for the Filling process in the Fill Finish Expansions programme. You will play a large role in ensuring that the Filling solution is well documented and implemented to deliver the business impact. You will be expected to use your previous Isolator Filling line experience working within the Filling Work package on various technical tracks within the project framework. The filling work package is responsible for delivering solutions designed for minimal human interventions and of the highest compliance. The work package also has the mandate to check the progress of machine construction via oversight activities at supplier site thus leading up to managing successful FAT and subsequent SAT-IQ-OQ phases in our production floors globally. The key tasks will be:
  • Providing Isolator Filling expertise in various sub-tracks under the project and own these tracks.
  • Development of future process flow with focus on designing flow and processes according to the aseptic standards and authority requirements.
  • Preparing documentation and execute test and validation of activities within your area of responsibilities (FAT, SAT, IQ/OQ).
  • Be part of the vendor oversight during the equipment build and test phase.
  • Design and implement training setup for operations as well as authority inspection and other relevant compliance activities.
    • Qualifications
    In this role we expect you to have:
  • A background within the natural science or engineering areas, which could be as technician, supporter, mechanical engineer, master’s degree in chemical engineering or similar education.
  • +5 years of work experience within aseptic filling systems, that caters around Isolator Filling technology.
  • A quality mindset and a drive to create the “right” solutions.
  • An excellent command of verbal and written English.
  • Experience from project work is desirable.
    • As a person you are comfortable with taking initiative and have a strong personal drive and dedication. You bring a good sense of humour 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. About the department Our department Technology Standards is situated in the newly created SVP area of Fill & Finish Expansions. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of [xxxxx]’s 50,000 employees. Fill & Finish Expansions is a newly established and growing area with the responsibility to design, plan and built all new aseptic filling capacity across [xxxxx] to serve needs of millions of patients. We do it by rethinking our aseptic production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. Fill & Finish Expansions has a clear global approach, where you will be working with multiple sites and cultures across the world. Working at [xxxxx] We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information please contact Deepak Krishnakumar, Senior Manager of Manufacturing Projects at +[xxxxx]or get to know us better by visiting Novo Nordisk Global Manufacturing Careers. Deadline 20 May 2024. 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 [xxxxx] 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 Nordsjælland

    Jobbet er oprettet på vores service den 17.1.2024, men kan have været deaktiveret og genaktiveret igen.

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