Senior Validation Engineer
Hillerød, Capital Region of Denmark, DK
Are you passionate about validation processes? Do you have extensive experience in writing and reviewing validation documentation? Would you like to join a team at Novo Nordisk, where team members are highly skilled, while being equally focused on injection moulding tools and spare parts?
If so, you might be the dedicated Validation Engineer we are looking for! Read on and apply today for a life-changing career.
The Position
As a Senior Validation Engineer, you will write and review validation plans, protocols, and reports associated with, among others, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Your main focus will be on writing validation deviations and driving related problem solving.
Some of the days you will provide updates on board meetings on the status of validation activities and ensure close collaboration with production on running validations. In this role, some days is expected to participate in relevant board meetings in production when necessary.
The main tasks will be to:
• Write and review validation plans, protocols, and reports associated with Installation Qualification, (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Drive each validation process by use of project management and by collaborating across the organisation with stakeholders from Quality Assurance (QA), Logistics, Production, Project Management and Production Support for both moulds and utilities.
• Assist Logistics and DCM Moulding Support in colour validations, variant validations, spare part validations etc. coordinating with production and logistics.
• Assist in and drive problem solving through systematic problem-solving tools, involving appropriate stakeholders.
• Participate in, and drive, planning activities with stakeholders across multiple areas.
Qualifications
To succeed in this role, you have:
• At least a bachelor’s degree in mechanical engineering or similar.
• Extensive experience in validation processes and documentation.
• Experience in injection moulding machines and verification.
• Good Manufacturing Practice (GMP) experience.
• Excellent communication skills in Danish and English.
As a person, you have good interpersonal skills, are process oriented and can communicate to colleagues and stakeholders in a simple way. In this position, it is equally crucial to support the team in fostering a positive spirit and help building a strong department. We never forget that a true team player leads from the front, embodying a solution-oriented mindset
About the Department
Being a part of Novo Nordisk's Device Component Production (DCP) means working with a focus at one of the world's largest and most successful pharmaceutical companies. Our DCP organisation is responsible for manufacturing and sourcing of devices and device components and as such plays a vital part of Novo Nordisk's delivery to our patients.
You will join our Project and Data Execution team at site Hillerød, a diverse team solving a multitude of tasks across the organisation - ranging from Validation and Verification of moulds and associated spare parts, across designing and deploying reporting and knowledge sharing solutions to participating in, and run, small and large projects.
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.
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 Peter Morrud at +45-34448354.
Deadline
23 February 2025.
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.