Operational Responsible for Fill & Finish Expansion

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Operational Responsible for Fill & Finish ExpansionCMC & Product SupplyOdenseDo you have a passion for ensuring compliance and driving quality in production processes? Can you back it up with your education or professional experience?If you are ready to make impactful contributions within a dynamic team, we want to hear from you – apply now and Join us at [xxxxx] Odense as an Operational Responsible for Fill & Finish Expansion (FFEX)!Your new roleAs the Operational Responsible, you will play a crucial role in designing, supporting and overseeing packaging and assembly processes within the Odense site expansion project. Your expertise will be essential in ensuring compliance, maintaining product quality, and driving effective execution of projects. You will collaborate closely with various stakeholders to implement and optimize processes within our production environment.Your primary tasks will include:
  • Leading the design and execution of packaging and assembly processes, ensuring alignment with project goals and quality standards
  • Coordinating and supporting validation activities to confirm compliance with regulatory requirements and established procedures
  • Collaborating and communicating effectively with process partners, suppliers, and internal teams to achieve timely and efficient solutions
  • Developing and leading commissioning strategies related to packaging and assembly processes in partnership with the project team
  • Establishing and setting directions for procedural and process documentation for the department to maintain consistency and adherence to quality standards
  • Ensuring effective execution and oversight of FP TI projects while maintaining a strong focus on quality and validation based on Science and Risk-based Validation (SRV)
  • Supporting Quality Management System (QMS) activities, including handling Change Requests, deviations, and document control effectively
    • Your new departmentIn CMC & Product Supply, we cover the full value chain from drug and device development to marketed [xxxxx] products. We are more than 30,000 colleagues across the globe with the shared responsibility of scaling molecules, processes, devices, and products, dedicated to supplying life-saving medicines to the patients who need them most.You will join the Fill & Finish Expansion (FFEX) team, a group dedicated to building the factories of the future. Our dynamic and innovative environment provides ample opportunities for professional growth and development. Currently, we are expanding our production capabilities to reach more patients by constructing a new facility in Tietgenbyen in Odense. This project is part of a broader initiative encompassing various activities worldwide, all within our Fill and Finish Expansion program (FFEx).To learn more about Fill & Finish Expansions in [xxxxx] visit our career site here: [xxxxx] Odense.QualificationsTo be suitable for this role we want you to have:
  • A Bachelor or above degree in relevant field (chemical, biotechnology, or engineering etc.) and/or working experience in a GMP production environment
  • Knowledge of how production lines function, and an understanding of the validation processes, including machinery changes on compliance
  • Familiarity with the regulatory compliance aspects associated with GMP and regulations
  • Familiarity with quality assurance practices and LEAN methods
  • Proficiency in English; preferably also Danish language, but not required
    • On a personal level, you possess a strong quality mindset and align closely with the NN Way principles. You are self-driven, take ownership of your tasks, and are committed to delivering quality results on time. Your excellent communication and coordination skills enable you to foster transparency and collaboration across teams.Working at [xxxxx]Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.What we offerThere is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.ContactIf you would like to know more about the position, please contact Manager Pernille Bauer Brun at [xxxxx] Be advised Pernille will not support queries about your recruitment status.Deadline3 August 2025You 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. Please upload your CV in English, and to ensure an efficient and fair recruitment process, refrain from adding a photo in your CV.[xxxxx] is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Odense

    Jobbet er oprettet på vores service den 11.7.2025, men kan have været deaktiveret og genaktiveret igen.

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