Project Quality Engineer

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Hillerød

Are you motivated by working in a changing environment? Does the idea of being involved in a new capacity expansion project where you can influence, and impact future API (Active Pharmaceutical Ingredient) production facilities sounds interesting? Then here is a great opportunity to become a part of a team, where we turn ideas into actions. Apply today for the position as our project quality engineer in a new large green field project.  The position
In Biotech & Rare Disease (BRD) we are planning to expand our production facilities in Hillerød, to meet the future need of our expanding product pipeline. Therefore, we are looking for a project quality engineer. As a project quality engineer you are part of the executing Project Quality Management (PQM) work package for the newly published API facility in Hillerød. In this role, you have the responsibility to create a common and standardized approach for the foundation of the quality documentation (e.g. templates) in collaboration with the rest of the team. Furthermore, you will be responsible for communication of the standardized tools/templates used in the project and act as a subject-matter-expert (SME) in the process. Furthermore, you will be part of the other activities related to the work package which is (but not limited to):
  • Develop standardisation of project specific templates and guidances

  • Ad hoc guidance for stakeholders in the project (internally and externally)

  • Strong collaboration with leads (IT-, operational- and equipment responsible) and QA

  • Driving validation documentation across the project (for example master validation plan)

  • Execute training sessions in the developed tools and standards in the project

  • As a Project Quality Engineer, you will be part of ensuring that our commissioning/qualification/validation documentation complies with Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).   Qualifications
  • Academic degree within biochemistry, chemical engineering, science, pharmacy or similar

  • Experience within quality management system in the pharmaceutical industry is an advantage but not a requirement. Preferably, this also includes project activities.

  • Experience and motivation for communication and training of larger audiences

  • Thrives in a fast-paced environment with many concurrent tasks

  • Fluent in spoken and written English


  • As a professional you are working independently, you thrive driving initiatives and have a forward-thinking outlook. As a person, you enjoy collaborating, learning and sharing information with others. You are driven by achieving great results together with colleagues. You possess excellent communication and collaboration skills enabling you to interact with your many stakeholders from different functions and parts of the organisation.
    About the department
    Join us at 25L API Capacity Expansion and become a part of one of Novo Nordisk’s most significant expansion projects, embedded in Biotech & Rare Disease (BRD). In BRD, we are building a new API production facility in Hillerød that will employ around 340 colleagues. The highly automated production facility will be equipped with state-of-the-art technology that is flexible to accommodate new processes and products. We manufacture through complex chemical and biotechnological processes requiring a high level of expertise, commitment, and engagement from our employees and including cultivation, recovery, purification and freeze-drying. It will also expand our portfolio of clinical late phase products and increase our capacity to serve more people living with rare disease and serious chronic diseases.  To drive the project and reach the initial phase of production, we need your support. We do not only drive change for our patients – we also drive life-changing careers for our employees by promoting a learning culture with high levels of trust, innovation and development throughout the organisation. Are you ready to join the project team and our journey?
    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 in 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. 2500 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 are also stiving 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
    If you would like to discuss further, you are welcome to contact Project Manager Martin Rosenkjær at +45 34 48 32 48 Deadline
    1 January 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 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.


    Information og data

    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 8.12.2023, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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