Clinical Trials Utility Engineer

3 weeks ago


Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time
About the Role

We are seeking a highly skilled Utility Engineer to join our Clinical Supply Packaging & Shipping (CSPS) team at Novo Nordisk A/S. As a key member of our team, you will be responsible for the current and future equipment/facilities, including HVAC, BMS, and FMS.

Key Responsibilities
  • Oversee upgrades, rebuilds, and problem-solving initiatives to maintain equipment in a validated state and enhance performance
  • Drive LEAN processes for systematic problem-solving and execute project management activities
  • Work with strategic planning and implement new equipment/facilities to support the growth in clinical trials
Requirements

You hold a Bachelor or Master in Biotechnology, Design, Process, or similar. Hands-on experience within equipment and validation is a plus. Ideally, you join the team with minimum 3 year's experience and a background within GxP regulated environment in the pharmaceutical industry. But other regulated industries like aero/space, electronics, plastic production, and similar are also durable.

The following experiences will be a plus:

  • Microsoft Office, Teams, and Planner
  • GMP-knowhow / change control / deviation handling
  • Management of GxP facilities including troubleshooting, optimisation, and handling of critical alarms
  • Validation of GxP facilities including HVAC, BMS, and FMS
  • Project management with technical knowledge
  • Stakeholder management cross-functionally and with external suppliers
About the Department

The CMC Clinical Supplies Packaging & Shipping (CSPS) department is in Måløv and currently consists of 110 employees divided into six teams. Our overall goal in CMC Clinical Supplies is to ensure timely supply of our clinical studies to patients.

We are responsible for packaging and distributing products for clinical studies and we work closely with the rest of the Clinical Supply Chain at CMC to achieve our ambitious goal of delivering high-quality products on time to patients worldwide. We continuously work to optimize our processes, reduce lead time, and efficient use of resources using various LEAN tools.



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