Senior Validation Engineer

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Kalundborg

Do you want to be an active part of the development of the world’s state-of-the-art insulin production facility? Are you driven by using knowledge and a process-oriented approach to guide and mentor others to succeed? Do you value being part of a highly skilled team that makes a difference while having fun in their daily work? Then, apply today and join us for a life-changing career! The position We are on a very exciting journey of designing and building a monumental state-of-the-art API manufacturing facility on our site in Kalundborg. The position is permanent and offers great opportunities for utilizing and developing your professional skills as well as your personal skills. It also gives you the opportunity to have a significant impact on our new facility while also contributing to improving the lives of millions of people all around the world. As our Senior Validation Engineer for API (Active Pharmaceutical Ingredient) in Kalundborg, you will be part of ensuring that our commissioning/qualification/validation (CQV) documentation complies with Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP). Together with a team, you will be responsible for:
  • Acting as a validation subject matter expert, ensuring that a science and risk-based validation approach is applied for defining our CQV-strategy
  • Facilitating Risk Assessment workshops
  • Establishing an overview of validation activities and priorities and creating a link between multiple project teams (Work Packages)
  • Facilitating workshops to ensure validation activities are executed effectively.
  • Making sure that internals as well as external stakeholders are properly prepared for validation activities throughout all the phases of relevant projects
  • Qualifications We imagine that a successful candidate would have:
  • An engineering or academic degree in natural sciences or similar.
  • Several years of experience with validation projects, and commissioning/validation/qualification in GMP manufacturing.
  • Ability to support translating the needed innovation in the documentation and create conditions for overcoming potential risks and roadblocks.
  • Ability to teach validation strategies and well versed in risk analyses
  • Thrives in a fast-paced environment with many concurrent tasks
  • Proficiency in English, written and oral. Danish skills will be an advantage.
  • Even if you can’t tick all the boxes, we would really like to hear from you and see your application – you might be the person we are looking for! In this role, you will manage multiple stakeholders (external and internal) simultaneously, and therefore, we hope that you enjoy collaboration – and that you are outgoing and ready to take the lead on discovering and defining opportunities to drive our projects forward. It will also be important that you thrive in a challenging, dynamic and ever-changing environment, and that no assignment is too big or too small for you to take on. We would love to hear from you if you are proactive, constructive, innovative, solution-oriented and have a flexible mindset. About the department The position as Validation Lead is placed in the Business Support department in PPV in Kalundborg, which is a part of the global Product Supply division counting about 14,000 employees worldwide. Our department is composed by highly skilled, committed and ambitious colleagues who have a fair bit of fun while delivering high-quality standard. Working at Novo Nordisk At Novo Nordisk, we don’t wait for a change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Karina Bjerg Bech, +45-34487978 (On vacation week 26-27-28) Deadline 15. august 2023. Please, note that applications are screened on an ongoing basis, so you are encouraged 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.


    Information og data

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

    Arbejdsstedet er beliggende i Kalundborg.

    Jobbet er oprettet på vores service den 27.12.2022, 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.
    • Øvrige
    • Kalundborg

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