Senior Validation Engineer

Location:

Hillerød – Frederiksborg, Zealand, Denmark

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Information Technology Jobs

Other Industries & Skills:

Education & Training, Engineering, Finance, Banking & Insurance, Health, Nursing & Social Services Manufacturing, Sales

Job ID:

131765605

Posted On:

05 April 2025

Are you an experienced Validation Engineer or Validation Lead ready to take the next step in your career? Do you have a passion for sharing your knowledge of manufacturing process validation to support our production capacity expansion? Do you thrive on enhancing manufacturing pro-cesses, driving efficiency, and making a real impact on global projects? Could your expertise in defining validation strategies within the pharmaceutical industry set the direction for validation, with a focus on robust processes and product quality? If these questions pique your interest, seize this unique opportunity today and apply for the Senior Validation Engineer position in our Assembly Validation & GMP Team within the Finished Product Manufacturing Science and Tech-nology (FPMSAT). Read on, apply today!

The Position

As our Senior Validation Engineer / Lead, you will be responsible for defining and executing de-vice assembly validation activities across multiple geographical locations. You will set the direc-tion for continuous improvement of science and risk-based validation while mentoring colleagues in validation.

You will play a key role in the projects by:

• Managing and contributing to validation activities from basic design and establishing Us-er Requirement Specification (URS) through to process risk assessment and to performance qualification (PQ) of new production lines.

• Driving the standardization and Lean initiatives within validation as we implement multi-ple lines at different sites, ensuring conformity with our corporate risk-based validation approach.

• Engaging in innovative validation practices, such as remote Factory Acceptance Tests (FAT), and leveraging validation activities for new solutions to our final customer.

• Establish key validation documentation for the future standards.

• Overseeing testing processes to ensure our production systems remain of the highest quality and efficiency.

In return, you can expect a rich professional experience with strong collaboration with stake-holders ranging from corporate to local sites, R&D, Production, Suppliers, Quality Assurance (QA), and specialists from various domains. Travelling periods/days are expected from this role.

Qualifications

To succeed in this role, we are looking to connect with candidates who:

• Have at least 5 years of experience as a Process or Validation Professional/Engineer with-in a cGMP environment, with a preference for experience in devices manufacturing and development.

• Hold an academic degree in engineering, biology, chemistry, pharmacy, or a related sci-entific field.

• Have a strong understanding of the science and technical aspects of manufacturing pro-cesses.

• Exhibit a strong quality mindset, complemented by experience in drug or device devel-opment.

You have professional proficiency in English (both written and spoken).

As a person, you possess expert knowledge and hands-on experience with quality risk management and validation in medical device manufacturing. You have an innovative, dynamic, and quality mindset and a focus on cLEAN principles, and you have  excellent collaboration and  communication skills, as this role involves working closely with external partners.

About the Department

You will join FPMSAT within the Assembly department. We play a crucial role in bridging Device R&D to production, supporting the development of new devices and managing the implementa-tion of manufacturing capacity worldwide for both new and marketed products. Our belief is that a diverse workforce directly supports our goal of delivering the highest-quality work: we are cur-rently made up of almost 40 different nationalities in FPMSAT, representing a range of experienc-es and educational backgrounds. The Assembly department, located in Hillerød, includes over 100 highly engaged professionals, including project managers, specialists, validation engineers, process engineers, and science experts. We collaborate with multiple stakeholders and strive for excellence in project execution, scientific engineering, innovation, and technology.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change; we drive it. We are a dynamic company in a rapidly evolving industry, and we recognize that our past successes won’t necessarily ensure our future ones. We embrace the spirit of experimentation, striving for excellence without fixating on per-fection. We proactively seize opportunities for development across all areas, from research and development to manufacturing, marketing, and sales – all aimed at improving patient care.

Contact

For further information, contact manager Jabin Rafiq +45 3079 7725.

Deadline

April 20, 2025. Please note that applications will be reviewed, and interviews scheduled on an ongoing basis. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from including a photo in your CV.

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

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