Advanced validation engineer

Are you experienced in supporting and setting validation & qualification processes for medical manufacturing? Would you like to play a key role in establishing, maintaining and improving our validation frameworks? Read on and apply today for a life-changing career.

The Position

As an Advanced Validation Engineer, you will be responsible for identifying and managing low-to-medium complexity projects, implementing change control, and establishing validation tools and best practices. You will focus on facilitating process risk assessments for medical device  production, defining control strategies, developing validation frameworks, and ensuring risk control measures are effectively implemented. This includes supporting both internal production and external suppliers while maintaining operating procedures and process monitoring systems. Moreover, you will:

• Drive validation processes through project management and collaboration with stakeholders from Quality Assurance (QA), Logistics, Production, Project Management, and Production Support for both moulds and utilities.
• Assist in and drive problem-solving efforts using systematic problem-solving tools while involving appropriate stakeholders.
• Participate in and lead planning activities with stakeholders across multiple areas.

Qualifications

To succeed in this role, you have:

• At least a bachelor’s degree in either Manufacturing or production engineering, Bio- medical engineering,  , or a similar field.
• Experience in medical manufacturing validation processes, documentation and  process risk assessments for production
• Preferred experience with injection moulding manufacturing processes
• Good Manufacturing Practice (GMP) experience.
• Experience with risk assessments and quality-related tasks
• A minimum of 2 years of work experience.
• Excellent communication skills in English; Danish is an asset.
• Beneficial to have knowledge or familiarity of Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT) etc. and/or similar experience of pFMEA.

As a person, you have strong interpersonal skills, are process-oriented, structured and can communicate complex information clearly to colleagues and stakeholders. It is equally crucial to foster a positive team spirit and contribute to building a strong department. A true team player leads from the front, embodying a solution-oriented mindset.

About the Department

You will be joining a department with dedicated colleagues within plastic processing, tooling, metal & electronic components and automation in Finished Product Manufacturing Science & Technology in Hillerød. We develop the equipment and processes that transform new Medical Device designs into actual products for our patients, bridging the gap between the development departments and the Injection Molding production sites.

We enjoy sharing our knowledge, and we are eager to get to know you and learn from you. If you appreciate collaboration in a creative and ambitious environment, you will feel at home with us.

About Site Hillerød

Site Hillerød is an innovative and fast-growing production site. With over 4,000 talented employees, we work together to drive change for people living with serious chronic diseases. The site is located in beautiful natural surroundings, and we offer a diverse array of career paths at all educational levels. Join our vibrant community at Site Hillerød and ramp up your career while we ramp up our production! Get to know us better - visit our Site Hillerød career page.

Novo Nordisk Hillerød

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact 

For further information, please contact Manager Iranga Perera irpb@novonordisk.com.

Deadline 

March, 11.

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 adding 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.