Aseptic Manufacturing Engineer

2 weeks ago


Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

About the Role

The Aseptic Manufacturing, Technology and Innovation department at Novo Nordisk is seeking a skilled Validation Engineer to drive innovation and develop technologies for our aseptic manufacturing processes. As a key member of our team, you will play a crucial role in scaling our production capacity while maintaining product quality and compliance with cGMP regulations.

Responsibilities

As our new Validation Engineer, you will be responsible for developing and implementing validation strategies for our aseptic manufacturing processes. This will involve close collaboration with project managers, manufacturing facilities, and specialists to define user requirements, test plans, and develop concepts for global validation. You will also establish documentation packages for developed solutions and participate in testing and qualification at production sites.

Requirements

To succeed in this role, you will have a degree in engineering, biology, chemistry, pharmacy, or a relevant scientific field. You will also have 2 years of experience as a Process- or Validation Professional/Engineer within a cGMP environment, preferably with experience related to aseptic manufacturing requirements. A good understanding of science and technical aspects of aseptic manufacturing processes is essential, as is a innovative and Lean mindset. Professional proficiency in English is also required.

About Us

In the Aseptic Manufacturing, Technology and Innovation department, we drive innovation and develop technologies to prepare Novo Nordisk Aseptic Manufacturing for the future. We scale our production to serve more patients through a compliant and efficient production network on the forefront of technology. Our skills include aseptic manufacturing and process expertise, mechanical design, automation, robotics, modelling, simulation, and equipment validation. We are responsible for a Development Test Center in Kalundborg and an Innovation lab in Bagsværd. Our team currently counts app. 50 employees plus students and consultants. We are an engaged, diverse, and international team working primarily from our offices in Bagsværd, Gentofte and Kalundborg.

At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we're all working to move the needle on patient care.

If you are interested in this challenging role, please do not hesitate to contact Mie Bach-Pedersen (Manager) at MPDB@novonordisk.com. We look forward to hearing from you.



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