Equipment & Qualification Responsible

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Job description

Location
Måløv, Denmark
Job category
Engineering & Technical
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Equipment & Qualification Responsible
Måløv, Denmark, Onsite
Clinical Supply Packaging & Shipping

Do you want to gain hands-on experience with high-tech packaging equipment and help ensure patient safety in clinical trials? Are you interested in learning how deviations, troubleshooting and qualification/validation work in a regulated environment-while keeping solutions practical and fit for purpose?
If yes, this could be your next step.

Your new role
As our Equipment & Qualification Responsible, you will support the day-to-day operation and maintenance of our validated clinical packaging lines in Måløv. Your learning journey will help you contribute to keeping equipment in a validated state by following established procedures, supporting documentation, and working on defined improvement and troubleshooting activities under guidance.

You will work closely with project managers, QA, internal stakeholders, and external suppliers. We operate with limited shutdown windows, so planning and realistic execution (with support from the team) are key.

Your key responsibilities
* Support maintaining validated state of packaging lines (performance checks, lifecycle documentation updates) according to procedures
* Support troubleshooting and contribute to systematic problem-solving activities (including LEAN/problem-solving tools) within a defined scope
* Support deviations, change control and CAPA activities with a "right-first-time" mindset
* Support qualification/validation activities and contribute to 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 continuous improvement (simplify, standardise ways of working, 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 an eager, hands-on engineer who gets things done, stays calm under pressure, and can work constructively in a team.

Your experience and background
* Engineering degree (BSc/MSc or equivalent) in e.g. Mechanical Engineering, Automation, Process, Production, or similar
* Some hands-on experience with industrial machinery and technical problem solving (e.g., internship, project work, thesis, or early professional experience)
* Interest and/or experience working in a regulated environment (GxP/GMP pharma is ideal; other regulated industries can also be relevant)
* Basic understanding of qualification/validation and working in controlled/validated setups (training will be provided)
* Ability to support project execution tasks (planning, stakeholder updates, documentation, follow-up on vendors/deadlines) within a defined scope

It's a plus if you have experience with
* GMP change control, deviation handling, CAPA (or demonstrated exposure through training/projects)
* Equipment validation/qualification exposure (e.g., supporting parts of DQ/IQ/OQ/PQ)
* Microsoft Office, Teams and Planner; Veeva Vault (or similar systems)

How you work
* Robust and solution-oriented: you learn quickly and 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 follow established procedures and understand how patient safety is protected through compliance and documentation
* Curious and willing to challenge "how we've always done it" to make solutions simpler and more sustainable over time

What we offer
At Novo Nordisk, you'll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary: For this role, the Annual Base Salary ranges from 570,200.00 to 838,100.00 DKK, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate's skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy here.

Deadline
May 24th - 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