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Responsible Engineers for Process Engineering

Hillerød, Denmark

FUJIFILM Diosynth Biotechnologies located in Hillerød, Denmark, is expanding. We therefore have several open positions in Process Engineering as equipment responsible engineers. In this role, you will provide crucial support for clinical and commercial manufacturing of drug substance, improvements, quality/operational robustness/cost savings initiatives while ensuring compliance with cGMP, quality and safety standards for FDA regulated products.

You will be part of the Process Engineering team which is situated in the Engineering Support department. The overall responsibility of Process Engineering is to secure that upstream and downstream manufacturing equipment is available for manufacturing when needed.

The position interacts closely with the Drug Substance manufacturing team as well as several engineering disciplines such as Quality, Automation, Validation, Process Science, Plant Engineering, Maintenance, and Project Engineering.

Responsibilities

  • Support the production and secure reliable and robust operations. Onsite support needs may occur in the evening and/or weekends and participation in the engineering on-call program is required on rotational basis.
  • On the floor presence and support after any critical process equipment changes.
  • Participation in campaign readiness meetings including communication of status of projects
  • Performing change over from campaign to campaign (Equipment setup)
  • Focus on operational robustness and cost efficiency in everyday work and processes. Drive, support, and perform assessment based on impact and effort for prioritization.
  • Drives equipment changes, specify and install new equipment, provides engineering technical support and troubleshooting for all equipment as required.
  • Review validation protocols and supports validation testing.
  • Participate in cross-functional teams to implement changes and / or improve existing processes.
  • Provide training as needed to ensure production team understands equipment functionalities.
  • Communicate progress, status, and issues to stakeholders and upper management.

Requirements:

  • Minimum a Bachelor’s Degree within engineering or similar discipline.
  • 2+ years of experience in the areas of GMP manufacturing, engineering or facilities in a pharmaceutical environment is preferred.
  • Enjoy working as part of a team and also being comfortable working independently.
  • Curiosity and sense of urgency.
  • Experience working with equipment in a commercial GMP environment is a big advantage.
  • Fluent in English both verbal and written.

If you need more information, please contact Esben Eggertsen, Manager Process Engineering, +45 41949739.

Please apply online in the HR system, applications received in other ways will not be considered. We are reviewing applications on continuous basis and urge you to apply as soon as possible, however delays in response time should be expected as we enter the vacation period.


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