CQV & Engineering Expert

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Novo Nordisk Pharmatech - Køge Are you passionate about strategic problem-solving and development? Would you like to work with developing a new facility and defining the way we work with Commissioning, Qualification and Verification (CQV)? Can you interact with multiple stakeholders across different levels and disciplines including external vendors and suppliers? And do you have solid experience in Engineering & Science and Risk-based validation? Then we might have the right position for you as our new CQV & Engineering Expert at Novo Nordisk Pharmatech in Køge. Apply today for a life-changing career! The position Join us in building a new greenfield GMP production facility in Zealand, in line with modern standards, with sustainability and safety being key aspects during construction and operation! As our new CQV & Engineering Expert, you will utilize both your operational and your strategic skills. You will be fully responsible for defining the CQV approach for the project, including ensuring all supporting documentation is developed. In this role, you can look forward to:
  • Developing the Project Quality Master Plan
  • Defining the CQV approach for the project, based on Science and Risk-based validation
  • Training project participants in the CQV concept, as well as interacting with project team members to advise on Good Engineering Practice
  • Ensuring that the project has a defined CQV approach that is in line with the ISO & GMP requirements
  • Presenting the CQV Concept to relevant stakeholders, including customers, authorities and Novo Nordisk Pharmatech entities.
    • Your role will entail providing timely and relevant updates on status to all key stakeholders, reporting and adjusting for any deviations from your plans as you advance. You will provide clarity on responsibilities and expectations in relation to CQV to the project team. You can look forward to working with people with many different backgrounds, across organisational levels and geography – from reporting your results to top management to meeting the operators affected by your decisions. Qualifications To succeed in this job, we imagine that you have:
  • Experience with Science and Risk-based validation both on a strategic and operational level
  • Experience with large Capital Investment projects in a GMP-regulated environment
  • An engineering or scientific degree
  • Experience in working with an Engineering Service provider
  • You are fluent in written and spoken English
    • As a person, you will thrive in this job if you are open-minded and happy to meet new people as part of participating in project/cross-functional teams. You thrive in an environment where new challenges and focus can change quickly, but always with the overall common goal in mind. You can create a vision for the project team and share your optimism and solid plans that make people engaged in the project. You can involve people and structure the training. You have a pragmatic approach, you are keen on listening for optimisation suggestions while leaning on your own experience. About the department Your primary role for the next 3-4 years will involve supporting the various work packages on the project with CQV and Engineering related aspects. The project department is newly established and tasked with establishing a new greenfield facility. The organisation is still being developed and will, when fully developed have around 45 employees. Working at Novo Nordisk Pharmatech A/S Novo Nordisk Pharmatech A/S has 300+ employees and is 100% owned by Novo Nordisk A/S. The ability of Novo Nordisk Pharmatech A/S to produce and deliver quality products to the pharmaceutical industry, combined with our complete range of services within regulatory requirements, makes us a preferred supplier to many global pharmaceutical companies. Novo Nordisk Pharmatech A/S is a fast-growing company generating many exciting projects and offering excellent development opportunities. Contact If you have questions about the position, you are welcome to call Project Director, Andreas Kyhn Brejnholt +45 31 97 14 98. Deadline 16 April 2023. We are conducting interviews on an ongoing basis, so please apply as soon as you can. 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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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Køge.

    Jobbet er oprettet på vores service den 24.3.2023, men kan have været deaktiveret og genaktiveret igen.

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