Quality Engineer, Automation and IT, at Novo Nordisk Engineering

NNE Inc.; Kalundborg; A distancia; DKK 600.000 - 900.000; Jornada completa

Descripción de la vacante

Novo Nordisk Engineering (NNE) is seeking an experienced Quality Engineer for Automation and IT in Kalundborg, Denmark. You will lead validation activities, provide strategic guidance on GMP compliance, and drive quality across complex automation projects in pharma engineering.

You will work with multidisciplinary teams to ensure deliverables meet quality expectations, timelines, and customer requirements, with a focus on CQV, validation lifecycle management, and risk mitigation throughout the

Formación

• B.Sc., M.Sc., or equivalent degree in engineering, IT, life sciences, biotechnology, pharmaceutical sciences, or related field.
• Experience in CQV, validation, GMP, QA or project quality management in pharma, biotech or life sciences.
• Hands-on experience preparing and reviewing validation documentation (URS, FS/DS, SVP, IQ/OQ/PQ, risk assessments, test protocols).
• Knowledge of GMP, GAMP 5, ISPE guidance, data integrity, quality risk management, and validation lifecycle management.
• Ability to advise customers and project teams on validation strategy, compliance risks, and quality-related decisions.

Responsabilidades

• Leading CQV and validation activities for automation, IT, computerized systems, and equipment interfaces in GMP-regulated projects.
• Developing and reviewing validation documentation (URS, FS/DS, SVP, IQ/OQ/PQ, risk assessments, test protocols, and summary reports).
• Executing qualification and testing activities while ensuring GMP compliance and customer expectations.
• Collaborating with customers, suppliers, and project teams throughout FAT, SAT, commissioning, validation and handover.
• Managing validation risks, deviations, compliance issues and mitigation actions across projects.

Conocimientos

CQV

Validation

QA

Project quality management

Validation documentation

Educación

B.Sc./M.Sc. or equivalent in engineering/IT/life sciences/pharma

Descripción del empleo

Quality Engineer, Automation and IT, at Novo Nordisk Engineering

If you’re energized by quality, validation, and complex Automation and IT projects in pharmaengineering, we’d love to hear from you!

Who we are

We are a leading pharma engineering company shaping the future of API pharma engineering globally. Leveraging the expertise of 2,000+ employees across Denmark, India, and the US, we design, build and optimise pharmaceutical manufacturing facilities that are essential to the health and well‑being of patients everywhere.

Our success is driven by passion, innovation, and collaboration - with our customers and across our teams and disciplines. If you share our dedication to a noble cause and our passion for API pharma engineering, then NNE is the place for you.

About the role

We are looking for an AITQuality Engineer to join our AIT Project Quality Management team. In this role, you will be responsible for planning, driving, and delivering validation and quality activities within complex Automation and IT projects in the pharmaceutical and life science industry.

You will work as part of multidisciplinary project teams and act as a trusted advisor on validation strategy, GMP compliance, quality risk management, and project quality execution from project initiation through to handover. The role combines hands‑on technical validation expertise with project quality management responsibilities, ensuring that deliverables, quality expectations, timelines, and customer requirements are aligned throughout the project lifecycle.

Location: Denmark - Kalundborg

Experience: Minimum 5 Years

Department: AIT Project Quality Management

How you might spend your days

As an AIT Quality Engineer, you’ll be:

• Leading CQV and validation activities for automation, IT, computerized systems, and equipment interfaces in GMP-regulated projects.


• Developing and reviewing validation documentation, including URS, FS/DS, SVP, IQ/OQ/PQ, risk assessments, test protocols, and summary reports.


• Executing qualification and testing activities while ensuring compliance with GMP requirements, industry standards, and customer expectations.


• Collaborating with customers, suppliers, and project teams throughout FAT, SAT, commissioning, validation, and handover.


• Managing validation risks, deviations, compliance issues, and mitigation actions across projects.

Who you are

We care about who you are as a person. In the end, how you work, and your energy is what impacts the results we achieve as a team. As a person, you are:

• Able to work independently while building strong relationships with stakeholders.


• Comfortable balancing compliance, quality, timelines, and project risks.


• Eager to share knowledge and support the development of colleagues.


• Skilled at communicating complex validation topics in a practical way.


• Motivated by collaboration and delivering high-quality results in project environments.

What you bring to the role

In all positions, there are some things that are preferred, and others, a bonus. If you do not meet all the qualifications listed below, you are welcome to offer alternative experience that you think would be valuable in this role:

• A B.Sc., M.Sc., or equivalent degree in engineering, IT, life sciences, biotechnology, pharmaceutical sciences, or a related field.


• Experience within CQV, validation, GMP, QA, or project quality management in the pharmaceutical, biotech, or life science industry.


• Hands‑on experience preparing and reviewing validation documentation, including URS, FS/DS, SVP, IQ/OQ/PQ, risk assessments, and test protocols.


• Knowledge of GMP, GAMP 5, ISPE guidance, data integrity, quality risk management, and validation lifecycle management.


• Ability to advise customers and project teams on validation strategy, compliance risks, and quality-related decisions.

Life at NNE

NNE is short for Novo Nordisk Engineering. And for all of us who work here, NNE means so much more.

At NNE, you become part of a vibrant, project-based environment built on close day-to-day collaboration. The role is therefore primarily on-site, with physical presence at the workplace expected five days a week. Limited flexibility for occasional remote work may be accommodated in line with business needs.

We are, at our core, a people business and, as such, committed to continuously developing our people and the way we work together. We do not expect you to know it all from day one, and we truly believe a great start makes a real difference. We therefore welcome new colleagues with our award-nominated onboarding programme, supported by a range of in-house talent and development initiatives designed to support your long-term growth.

Deadline of application is 27th November 2026

Fair hiring

At NNE, we are committed to an inclusive recruitment process and equal opportunities for all job applicants. To maintain fairness, we request that you refrain from including a personal photo in your CV.