Digital Validation Expert

1 month ago


Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time
Job Description

We are seeking a highly skilled and experienced Digital Validation Expert to join our team at Novo Nordisk A/S.

About the Role

The successful candidate will be responsible for defining and executing validation strategies for Computerized Systems in both project and operation phases. This includes developing validation plans, conducting assessments, and ensuring system documentation is up-to-date.

Main Responsibilities

  1. Drive Validation Strategies: Develop and execute validation plans, including making validation reports, design reviews, and test strategies.
  2. Conduct Assessments: Perform supplier, IT risk, and functional assessments to ensure systems meet regulatory requirements.
  3. Maintain System Validations: Regularly review systems, handle deviations, and collaborate with stakeholders to create and update system documentation.
  4. Ensure Compliance: Verify systems adhere to internal and external regulations, identifying solutions for compliance gaps during audits and inspections.
  5. Foster Collaboration: Build strong relationships with colleagues and stakeholders through effective communication, workshops, and risk assessments.

About You

To succeed in this role, you have:

  • A B.Sc. in Engineering, Chemistry, Pharmacy, IT, or a related field.
  • Extensive experience in Computer System Validation (CSV) or manufacturing/production with recognized GMP certificates.
  • Strong knowledge of IT GxP validation in regulated industries like pharma or healthcare.
  • Experience with validation methodologies, including protocol development and execution.
  • Excellent communication skills and the ability to effectively communicate with stakeholders.

What We Offer

You will be part of Delivery & Guidance Services department within PS Data Foundation, contributing to global production data platforms. These platforms help extract and standardize data from production lines and IT/OT systems. In return, you can expect:

  • A competitive salary of approximately $80,000 - $110,000 per year, depending on your location and experience.
  • A dynamic work environment with opportunities for professional growth and development.
  • A chance to work with talented colleagues and make a meaningful impact in the pharmaceutical industry.

Why Choose Novo Nordisk A/S?

At Novo Nordisk A/S, we're dedicated to improving people's lives by defeating diabetes and other chronic diseases. With over 60,000 employees worldwide, we strive for diversity, inclusion, and continuous improvement. Join our team and become part of a global community that values innovation, collaboration, and excellence.



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