Validation Engineer

5 days ago

Hillerød, Denmark Novo Nordisk AS Full time

Do you want to play a key role in introducing new production equipment enabling Novo Nordisk to deliver medical pen systems to our patients around the world? Are you experienced in validation documentation, GMP and maybe even injection moulding? Then you might be the talented validation engineer we are looking for to ensure that new moulds are brought diligently into our global network of Contract Manufactures.

The job

You will be supporting the process of validating moulding tools at our Contract Manufactures, and primarily be responsible for review of validation documentation from our Contract Manufactures, including – but not limited to:

  • Performing change requests
  • Re-validation
  • Collaborating with a wide scope of stakeholders, e.g. Equipment Responsibles, QA, Project Managers, Contract Manufactures and other Validation Engineers.

Additionally, you will own the Supplier Validation Agreement process that defines how GCMD manages validation at Contract Manufactures by both ensuring compliance to, and continuous improvement of, the process to ensure that we keep meeting the growing demand for equipment validation worldwide.

In this role, stakeholder management is key, as you will interact with a wide scope of different areas.

You will be anchored in the team Technical Operation Moulds together with another Validation Engineer; however, you will be supporting across the department.

Qualifications

We are looking for candidates with:

  • A master’s degree within life science e.g pharmacy, engineering or similar.
  • Full proficiency in English, written and oral.
  • Experience with (equipment) validation process by execution and reviewing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
  • Experience in pharmaceutical/medical device industry or an industry with comparable high level of regulatory demands.
  • Familiarity with/knowledge about injection moulding of medical devices; it would be an advantage.

To succeed and thrive in this role, you:

  • Enjoy working in a dynamic environment and are able to do so in a structured and standardized manner.
  • Naturally manage several tasks simultaneously, without compromising quality.
  • Are proactive and conscientious and have an improvement mindset, always being curious about improving our existing way of working.
  • Possess personal authority that enables you to constructively critique and build trusting relations.

About the department

Global Contract Manufacturing Devices is located in beautiful surroundings in Hillerød, Denmark. The department Technical Operation consists of approximately 70 dedicated engineers and professionals. The department is responsible for maintaining our fleet of moulding, decoration, robot, assembly and packing equipment.

Contact

For further information, please contact Paw Holmgaard Krogh at +45 30754269.

Deadline:
8th of January 2025

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.

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 the communities we operate in. Together, we’re life changing.

#J-18808-Ljbffr

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