Clinical Trials Equipment Specialist

4 weeks ago


Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

About the Position

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

Your responsibilities will include:

  • Overseeing 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

As a Clinical Trials Equipment Specialist, 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 organizational goals.

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

As a professional, you are self-motivated, thrive working independently, and enjoy 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 preferable fluent in Danish also.

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 optimise our processes, reduce lead time, and efficient use of resources using various LEAN tools.

Working at Novo Nordisk

At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.



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