Senior Validation Engineer
Novo Nordisk
Senior Validation Engineer Assembly Validation & GMP Team Hillerød, Denmark Would you like to be in the frontline of device manufacturing development and ensure that quality products reach our patients? In this role you’ll take the lead in validation strategies to drive efficiency and ensure robust product quality. Your new role As part of the Assembly Validation & GMP Team within Finished Product Manufacturing Science and Technology (FPMSAT), your role will focus on driving device assembly validation activities across multiple global sites, while setting the direction for science and risk-based validation improvements. Day-to-day your tasks will include: - Managing and contributing to validation activities, including creating User Requirement Specifications (URS), conducting process risk assessments, and leading Performance Qualification (PQ) for new production lines. - Driving standardization and Lean initiatives for validation, ensuring compliance with corporate risk-based validation frameworks during the implementation of multiple lines at various sites. - Supporting innovative validation practices, such as remote Factory Acceptance Tests (FAT), and exploring new solutions for delivering value to customers. - Developing key validation documentation and contributing to future standards. - Overseeing testing processes to maintain high-quality and efficient production systems. You’ll work closely with stakeholders from corporate teams, R&D, production units, suppliers, Quality Assurance (QA), and specialists, while gaining exposure to diverse projects and opportunities for travel. Your new department In FPMSAT’s Assembly department, we bridge Device R&D to production, supporting new device development and implementing manufacturing capacity worldwide for both new and marketed products. Comprising over 100 professionals, the team includes project managers, validation engineers, process engineers, and scientific experts. With almost 40 different nationalities represented across FPMSAT, we thrive in a diverse and collaborative work environment, ensuring excellence in project execution, innovation, and technological advancement. Your skills & qualifications We’re seeking a Senior Validation Engineer who thrives in a dynamic and high-impact environment. You’ll bring with you: - At least 5 years of experience as a process or validation engineer within a cGMP environment, with a preference for experience in devices manufacturing and development. - Solid academic credentials, holding a degree in engineering, biology, chemistry, pharmacy, or a scientific field. - Strong understanding of the science and technical aspects of manufacturing processes. - Excellent quality mindset and professional proficiency in English (both written and spoken). As a person, you bring hands-on expertise in quality risk management and validation for medical device manufacturing, coupled with a focus on innovation, collaboration, and cLEAN principles. Your ability to communicate effectively and engage with external partners will be vital to success in this role. Working at Novo Nordisk Every day, we strive to drive change. At Novo Nordisk, we take an experimental approach to tackling challenges, embracing opportunities for development across research, manufacturing, marketing, and sales—all in our pursuit of improving patient care. What we offer Being part of a global healthcare leader means unparalleled opportunities for learning and professional growth, alongside benefits designed to support your career and life stage. More information If you have any questions about the role, please contact Manager Jabin Rafiq at +45 3079 7725 or Lone Munk at +45 34446605 Deadline August 1st, 2025. (Applications are reviewed on an ongoing basis.) Please include a brief statement about why you are applying in your CV or resume. To ensure a fair and efficient recruitment process, avoid including a photo in your CV.
Novo Nordisk is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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