Validation Engineer

The Hillerød Validation & Engineering support team is looking for a Validation Engineer who will complement the current capabilities of the team and participate in daily operations and expansion / improvement projects.

You will be part of the Engineering Support department where you will be responsible for maintaining the validated state of equipment and systems within both the Drug Substance Manufacturing and Finished Goods Manufacturing for drug product. This includes qualification of new and modified equipment / utilities, chambers /autoclave, sterilization and cleaning validation, problem solving and participation in projects, changes and investigations.

Main responsibilities

  • Planning and participation in key projects with validation impact
  • Preparing, performing and documenting commissioning, IQ, OQ and PQ activities
  • Participating in change controls
  • Planning, executing and documenting all phases of cleaning validation
  • Preparation of annual validation planning / reporting documents for product campaigns
  • Participation in audits and inspections

As the CDMO business at the Hillerød site expands, the Validation team anticipates increased complexity including new processes and a more diverse product portfolio. Candidates with experience and broad knowledge of both equipment and validation are therefore preferred.

Qualifications

You hold a Bachelors or higher degree in a relevant discipline and have relevant industry experience.

The successful candidate will

  • Have excellent communication / presentation skills, and be able to articulate complex information to stakeholders and supporting functions such as Engineering, QC, QA, manufacturing, Automation, maintenance, etc.
  • Have demonstrated knowledge of industry practices and current trends.
  • Possess practical experience and interest in hands-on validation execution
  • Have a mind-set of executing while striving for constant improvement
  • Have an ambition to engage and develop in a diverse group with a wide range of stakeholders
  • Be a team player who works well with colleagues and in cross-functional teams
  • Be conscious of lean ways of working and able to apply risk-based approaches to deliver efficient qualification
  • Have strong technical writing skills and good English skills

As a person you are self-starting and have a flexible, dynamic approach to work. You bring a friendly, can-do demeanour, professionalism and a good sense of humour.

We offer a position with an international business in growth and an attractive compensation and benefit package.

Application

Please upload your CV and cover letter as soon as possible and latest by Friday, 21th of February. For more information about this role please contact Talent Acquistion Lead Eva Op De Beeck at +45 72210860.

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