GMP & Validation Expert

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Kalundborg

In Novo Nordisk, we are investigating new API (Active Pharmaceutical Ingredients) manufacturing facilities to support the company portfolio of future oral and injectable pharmaceuticals. Would you like to join a dynamic global company and work on an exciting new project? Are you interested in the opportunity to establish potential new API manufacturing facilities that bridge new and automated technologies with strong know-how and expertise in biotech manufacturing? Apply now for a life-changing career journey and a chance to make a real difference! The Position As GMP & Validation Expert you will be overall responsible for setting the quality direction for a potential new production facility. Furthermore, you will:
  • participate in setting the direction of validation planning, design reviews, risk assessments, requirements for tests, qualification, and validation. A key design principle will be to copy existing design standards from other recent projects.
  • exercise strong leadership to keep the team focused on execution instead of comprehensive design considerations.
  • be an essential part of building a competent user organization, integrating with engineering partners, and collaborating with contractors while supervising their activities.
  • coordinate quality activities across the project and introduce newcomers to the Novo Nordisk validation system including the quality strategy, plans for design, qualification, and validation in the project.
  • be part of preparing overall quality documents within the project
  • Qualification To be considered for this position, you should have:
  • min 5 years of experience within GMP and pharmaceutical (API) manufacturing.
  • master’s level education in pharmacy, chemistry, pharmaceutical process engineering, or similar.
  • experience working with projects and validation within the pharmaceutical industry
  • strong and impactful communication skills
  • high quality mindset – being able to balance requirements against the fast progress of project activities
  • English proficiency (verbal and written).
  • On a personal level, you enjoy teamwork and are a strong motivator for others. You thrive in a multicultural environment that demands independence to make critical decisions. Building structure comes naturally to you, and you enjoy simplifying wherever simplicity can benefit in reaching the right goals faster. About Novo Nordisk Kalundborg Today, 3,200 employees of Novo Nordisk Kalundborg produce half of the world’s insulin and a number of biopharmaceutical products. With more than 50 years of expertise in large-scale biotech manufacturing, we are today the world’s largest insulin-producing facility. By joining Novo Nordisk Manufacturing in Kalundborg, we promise you a developing career, where you will be met with trust and responsibility by dedicated colleagues with diverse backgrounds in a successful company with a higher purpose and an inclusive environment. Together, we make a difference every day for more than 30 million people living with diabetes and other chronic diseases. Working at Novo Nordisk At Novo Nordisk, we don’t wait for 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 letting perfection stand in the way of good. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact F or further information, please contact Senior Project Manager Mie Boa Jacobsen at +45 3075 1354. Deadline Please apply no later than August 6, 2023 You do not need to attach a cover letter to your application, but please include a few sentences about your motivation to apply in your CV.  To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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 in 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 the 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 23.6.2023, 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.
    • Øvrige
    • Kalundborg

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