Equipment & Qualification Responsible

Equipment & Qualification Responsible

Måløv, Denmark, Onsite

Clinical Supply Packaging & Shipping

Do you want to own and develop high-tech packaging equipment that ultimately ensures patient safety in clinical trials? Are you strong in troubleshooting, deviations, and qualification while keeping solutions pragmatic, robust, and fit for purpose? And would you like to join a growing Clinical Supply Packaging & Shipping (CSPS) organisation where we package and deliver Novo Nordisk clinical trial products to patients worldwide?

If yes, this could be your next step.

Your new role

As our Equipment & Qualification Responsible, you will take ownership of our validated clinical packaging lines in Måløv. Your mission is to keep the equipment in a validated state, improve performance, and drive upgrades/rebuilds without losing sight of what matters most: quality, patient safety, and a sustainable way of working.

You will work closely with project managers, QA, internal stakeholders, and external suppliers. We operate with limited shutdown windows, so planning, prioritisation, and realistic execution are key.

Your key responsibilities:

• Own and maintain validated state of packaging lines (performance, compliance, lifecycle documentation)
• Drive upgrades/rebuilds and systematic troubleshooting (incl. LEAN/problem-solving tools)
• Handle deviations, change control and CAPAs with a “right-first-time” mindset
• Plan and execute qualification/validation activities and documentation suitable for audits
• Support implementation and qualification of new equipment to meet growing clinical trial demand
• Collaborate cross-functionally with a Design for Manufacturing (DfM) mindset across stakeholders and suppliers
• Contribute to challenging status quo: simplify where possible, standardise ways of working, and support digitalisation/automation—without compromising quality

Your new department

CMC Clinical Supplies Packaging & Shipping (CSPS) in Måløv consists of ~110 employees across six teams. Our overall goal is to ensure timely supply to clinical studies worldwide. We package and distribute products for clinical trials and continuously optimise processes, reduce lead time, and improve efficiency using LEAN tools.

Your skills and qualifications

We’re looking for a hands-on engineer who gets things done, stays calm under pressure, and can navigate strong technical opinions in a diverse team.

Your experience and background

• Engineering degree (BSc/MSc or equivalent) in e.g. Mechanical Engineering, Automation, Process, Production, or similar
• Significant hands-on experience with industrial machinery and technical problem solving
• Experience working in a regulated environment (GxP/GMP pharma is ideal; other regulated industries can also be relevant)
• Strong understanding of qualification/validation and working in validated setups
• Solid project execution skills (planning, stakeholder alignment, vendors, deadlines)

It’s a plus if you have experience with

• GMP change control, deviation handling, CAPA
• Equipment validation/qualification (e.g., DQ/IQ/OQ/PQ)
• Microsoft Office, Teams and Planner; Veeva Vault

How you work

• Robust and solution-oriented: you don’t give up when things get difficult
• Comfortable in a direct engineering culture: You can give and receive straightforward feedback and move forward constructively
• Pragmatic with high quality standards: you know how to find the right balance between “full documentation package” and “fit-for-purpose” while never compromising patient safety
• Curious and willing to challenge “how we’ve always done it” to make solutions simpler and more sustainable over time

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. We approach our work with an unconventional spirit, rare determination and constant curiosity. For over 100 years, this mindset has built a company where purpose, mutual respect and a willingness to go beyond deliver extraordinary results. You’ll join colleagues who care deeply about users, quality and doing the right thing. Especially when the technology is new, powerful and fast‑moving.

Deadline

April 6th - 2026

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.