Process Validation Engineer

Are you an experienced Validation Engineer ready for your next career challenge? Would you like to contribute your expertise in design and manufacturing processes to support our production capacity expansion? Do you possess a proven track record of process automation while maintaining top-notch product quality? Does the opportunity to oversee global projects ignite your passion? If you're eager to join our truly international team, apply today! The position
As a Process Validation Engineer, you will be responsible you will be responsible for planning, executing, and reporting validation activities for the manufacturing processes. The main manufacturing processes are injection molding, spring coiling, and assembly. You will lead and contribute to the validation activities, from basic equipment design and establishing user requirement specifications to process risk assessment, all the way to process validation of the new equipment. Furthermore, you support the validation of Novo Nordisk-owned manufacturing processes at CMOs around the world, requiring occasional travel. When your job is done the manufacturing processes are ready to deliver components and pre-assemblies to Novo Nordisk's final assembly and packaging sites from where the products will be shipped to millions of patients around the world who rely on our safe and reliable treatment. As such, you will
• Lead and contribute to the validation activities of the project, from basic design and establishing user requirement specification to process risk assessment, all the way to Process Validation of the new equipment.
• Create and execute validation plans, test protocols, test plans, and reports based on input from stakeholders to the process in scope.
• Ensure validation plans, protocols, etc. are followed and that any validation deviation is reported and solved to the root cause.
• Conduct peer review of validation documentation.
• Create and maintain validation procedures and templates, in close collaboration with your
• Stakeholders in other parts of the Novo Nordisk organization.
Qualifications
To succeed in this position, we expect you • Hold a BSc or MSc degree in Engineering.
• Possess relevant work experience in manufacturing development and/or GMP production of medical devices, including process validation.
• Demonstrate excellent communication skills and fluency in written and spoken English.
• Have experience as a Process or Validation Engineer in regulated industries (e.g., pharmaceuticals, medical devices, food, automotive).
• Embrace innovation with a Lean mindset or prior experience.
• Exhibit a strong grasp of the scientific and technical aspects of the manufacturing process As a person, you have an inquisitive nature and can strike the right balance between driving results and looking out for the well-being of your colleagues. You can structure and simplify complex subject matter and focus on the most essential aspects. You are a quick learner, not afraid to admit knowledge limitations and reach out to people across the organization. You enjoy working in teams and your communication is crisp, to the point, and respectful. You speak English fluently.
About the department
Novo Nordisk is significantly increasing its manufacturing capacity across all areas to serve many more patients in the coming years. To this end, a new Device Manufacturing and sourcing business unit (DMS II) has recently been created to ensure medical device component manufacturing and pre-assembly capacity for future growth. In the years to come, we are focused on establishing a new global manufacturing network consisting of suppliers, CMOs, and high-volume manufacturing capacity internally. Our DMS II organization has just started its growth journey, and this is a unique chance to be part of a start-up environment within a large multinational organization. In the coming period, a wide range of jobs will be posted covering a multitude of fields such as supply chain, engineering, operations, project management, people management, and business administration.
Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is not always easy. That is why we make room for different life situations and always put people first. We value our people for the unique skills they have, and we continuously work to bring out the best in them. Working at Novo Nordisk means working towards something bigger than ourselves, and it is a collective effort. Novo Nordisk relies on the joined potential and collaboration of its more than 57,000 employees. Together we go further. Together we change lives. Contact
For further information, please contact Ruud Luijs, Vice President at +45 3075 4866
Deadline
24 September 2023 Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible. You are welcome to send your application in English or Danish. To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.