Clinical Trials Equipment Engineer

7 days ago

Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

Are you a strategic thinker with a passion for utility systems and GxP equipment? Do you thrive in a dynamic environment where you can drive process optimisation and digitalisation? We're looking for a skilled Utility Engineer to join our Clinical Supply Packaging & Shipping (CSPS) team at Novo Nordisk A/S.

About the role

As a Utility Engineer, you will be responsible for the current and future equipment/facilities, including HVAC, BMS, and FMS. Your key responsibilities will include:

  • Leading upgrades, rebuilds, and problem-solving initiatives to maintain equipment in a validated state and enhance performance
  • Driving LEAN processes for systematic problem-solving and executing project management activities
  • Working with strategic planning and implementing new equipment/facilities to support the growth in clinical trials

You will work closely with various internal and external stakeholders, including project teams, regulatory bodies, vendors, and other departments. Your role will be pivotal in ensuring seamless collaboration to achieve our departmental and organisational goals.

About the department

The CMC Clinical Supplies Packaging & Shipping (CSPS) department is based 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 worldwide.

We are responsible for packaging and distributing products for clinical studies and 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 optimise our processes, reduce lead time, and efficient use of resources using various LEAN tools.

Your qualifications

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

We are looking for a self-motivated professional who thrives working independently and enjoys driving projects, improvements, and initiatives across an organisation. You have a structured approach towards challenges and utilise your problem-solving skills to create a standardised way of working. Furthermore, you have a visionary and innovative outlook to drive process optimisation and digitalisation. Also, you are passionate about the automation and packing machinery industry with a knowledge and interest in future products and solutions.

You are fluent in English and preferably fluent in Danish also.

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