Senior Test Method Validation Engineer

CMC & Product Supply
Hillerød, Denmark

Are you an experienced engineer in test method development and validation? Do you enjoy turning requirements and standards into robust, statistical, and scalable test methods that enable reliable design verification? If so, you might be the Senior Test Method Validation Engineer we are looking for.

Your new role

As Senior Test Method Validation Engineer, you will own the full lifecycle of design verification and shelf-life test methods - from concept and feasibility through development, validation, deployment, and continuous improvement. Your work ensures our verification data are trustworthy, compliant, and decision-enabling across device and primary packaging development.

Your key responsibilities will be to:

• Develop, validate, document, and improve test methods - from strategy and statistical justification to authoring test method documentation (e.g., Gauge Repeatability and Reproducibility (GR&R), measurement uncertainty budgets (MUB), Test Method Specifications (TMS), etc.), ensuring reliable, compliant, and submission-ready measurements


• Lead test method validation activities, own and maintain test method documentation, and ensure continuous robustness of methods


• Drive continuous improvement and compliance by reducing variation, implementing learnings from deviations, coaching colleagues in sound measurement practices, and acting as deviation and change request responsible


• Act as a senior subject matter expert by guiding project teams on test method development and validation, mentoring and training colleagues, and elevating measurement competence across the area


• Own and continuously improve cross-departmental test method processes, ensuring they are robust, standardised, scalable, and consistently used to enable high-quality, submission-ready verification data


• Scout and acquire new measurement techniques or equipment, support root cause analyses through data analysis and applied statistics, and proactively encourage the use of testing technology in development projects

Your new department

In CMC & Product Supply, we cover the full value chain from drug and device development to marketed Novo Nordisk products. We are more than 30,000 colleagues across the globe with the shared responsibility of scaling molecules, processes, devices, and products, dedicated to supplying life-saving medicines to the patients who need them most.

You will join the Device Verification Development (DVD) area within Final Product Development (FPDEV) in Hillerød, Denmark. We deliver exploratory testing, design verification and develop the Quality Control frame specifications across Novo Nordisk's device, primary packaging, and oral portfolio, partnering closely with development, QA and manufacturing colleagues. We are a diverse team of engineers and lab technicians unified by a strong quality and patient focus, where your expertise will directly impact the reliability and compliance of the products reaching patients worldwide.

Your skills & qualifications

We're looking for a Senior Test Method Validation Engineer who communicates crisply, thinks statistically, and works methodically. You're curious and pragmatic, able to simplify complex measurements without compromising data integrity. You enjoy coaching others and elevating verification quality across teams.

You will bring with you:

• MSc in Mechanical, Materials, Biomedical, Physics, Chemical Engineering, or similar; or BSc with significant experience in method development and validation for regulated products


• 3–5+ years of hands-on test method development and validation experience in medical devices, pharmaceutical, or similarly regulated industries.


• Proven experience within Quality Control (QC) is considered an advantage


• Strong command of measurement science and statistics, including proficiency in GR&R and measurement uncertainty analysis


• Solid knowledge of GxP design control and relevant device standards; skilled author and reviewer of validation protocols and reports


• Ability to translate system requirements into clear, objective test methods and data acceptance criteria; collaborative mindset working with engineers, lab technicians, QA, and project managers


• Professional proficiency in English (spoken and written)

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

More information 

For further information, please contact Charlotte Hunding at [email protected] or Jens Gustafsson at [email protected]

Deadline

4th of March 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.