Project Validation Engineer

Are you ready to play a crucial role in a groundbreaking capacity expansion project for Active Pharmaceutical Ingredient (API) production facilities? Do you have a passion for setting high standards and a solid background in qualification and validation within the pharmaceutical industry? Join our team as a Project Validation Engineer (PVE) and help shape the future of pharmaceutical manufacturing. The position
As a Project Validation Engineer, you will be a key player in the Validation Support team within the Project Quality Management (PQM) department. This role demands extensive validation experience and training as both Engineering Responsible (ER) and Operation Responsible (OR). Your focus will be on maintaining a strategic overview to ensure that validation structures and processes are robust and effective. Key responsibilities include guiding and supporting work package owners (WPOs), ensuring compliance with the prescribed validation approach (GMP and GEP), and fostering a culture of quality throughout the project. You will also step in as ER or OR when needed to ensure project success. Additional Responsibilities
• Assist work package owners (WPOs) with commissioning, qualification, and validation (CQV) activities.
• Ensure correct documentation and adherence to established standards.
• Facilitate seamless execution of CQV activities to meet project objectives.
• Work closely with various stakeholders and be actively involved in a range of validation activities.
• Thrive in a dynamic environment with competing priorities, requiring proactive engagement with diverse stakeholders to ensure project success. The Validation Support team includes several experienced and skilled Validation Project Engineers, each responsible for their own work package, as well as two dedicated document controllers.
Qualification
To excel in this role, we expect you to have
• At least 2 years of experience in working with validation, having previously held roles as both Engineering Responsible (ER) and Operation Responsible (OR).
• Experience in API production.
• A scientific academic degree in engineering, biology, chemistry, pharmacy, or a related field.
• Full proficiency in spoken and written English. About the department
Join our team at 25L PS API Expansion, one of Novo Nordisk's major expansion projects within Product Supply API. We're establishing a cutting-edge API production facility in Hillerød, set to employ around 340 colleagues. This highly automated facility will feature state of-the-art technology, allowing for flexibility to accommodate new processes and products. Our work involves complex chemical and biotechnological processes, demanding a high level of exper-tise, commitment, and engagement from our employees, covering
cultivation, recovery, puri-fication, and freeze-drying. This expansion will enhance our portfolio of clinical late phase products and bolster our capacity to support individuals affected by rare and serious chronic conditions. Working at Novo Nordisk Site Hillerød
At Novo Nordisk Site Hillerød, we are around 4,000 employees developing, producing, and filling injection pens to help patients around the world living with serious chronic diseases, such as diabetes and obesity. Here we also house a large factory dedicated to the
production of life-saving medicine for patients with rare diseases.
At Site Hillerød we employe a diverse range of talent working across the value chain, and we are growing fast. In fact, we are one of the most rapidly expanding sites in Denmark. For this reason, we have many exciting job opportunities and therefore we are
continuously looking for new talented colleagues. Join us and become a part of extraordinary teams implementing new technologies to take our production to new heights and serve even more patients.
The site is located in beautiful surroundings and offers good transportation options from Copenhagen, Hillerød, and the rest of North Zealand.
Currently, we are hiring many new colleagues in various engineering roles, including mechanical, automation, robotics, IT, validation, processes, manufacturing and much more. Also, we are looking for process operators, electricians, mechanics, technicians, project
managers, associate managers, and pharmacists or similar background.
Now is an extremely exciting time to join, as we are on an unprecedented growth journey and are serving more patients now than ever. Site Hillerød has a critical role to play in empowering Novo Nordisk to meet the needs of our patients now and in the future. Join us on this journey!
Join us as we shape the future of pharma production and contribute to our purpose of driving change to defeat serious chronic diseases! Get to know us better - meet us at [xxxxx] Contact
If you would like to discuss the role further, please contact Associate Manager, Masoud Hosseini, at [xxxxx] Deadline
31 January, 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.