Requirements: English
Company: Experteer Italy
Region: Anagni , Lazio
Job Opportunity: Validation Specialist at Novo NordiskAre you driven to use your knowledge and experience to help others succeed? Are you ready for a work life focused on quality and delivering life-saving medicines to patients within intralogistics at our global Fill & Finish sites?If you have experience in validating production equipment in a GMP environment and are eager to work on dynamic, global projects, we''d love to hear from you. Join us, and let''s shape the future together!In 2024, Novo Nordisk acquired the manufacturing site Catalent Anagni S.r.l., aiming to expand capacity to meet the needs of millions of patients. You will be part of a global team developing the pharma facilities of the future, working with advanced technology to innovate our fill & finish facilities.The PositionNovo Nordisk is investing heavily in new production facilities worldwide. With this expansion, we will play a crucial role in producing future products, and you will have the opportunity to be part of it.As our Validation Specialist, you will lead global validation efforts for key improvement and innovation projects across new and existing production facilities. Validation activities will focus on equipment, packaging, assembly, intralogistics, and warehousing.Your Main ResponsibilitiesEstablish validation documentation aligned with global requirements for new solutions, overseeing testing and qualification at initial installations.Plan and execute validation activities and risk assessments in accordance with regulatory standards.Collaborate with engineering and operations teams to perform validation testing, analyze results, and address non-conformities.Ensure compliance with safety, quality, and environmental standards, contributing to continuous improvement processes.Review design and documentation from suppliers.This role involves close collaboration with project managers, manufacturing teams, and specialists. You will be responsible for validating new solutions, establishing key documentation, and overseeing testing to ensure high standards of quality and efficiency in our production systems.QualificationsKnowledge of validation (VPL, DER, DQ, IOP/Q, risk assessment) and quality management systems.An academic degree in engineering, life sciences, or a related field.Several years of experience as a Validation Specialist or Engineer.Experience within a GMP-regulated environment is highly beneficial.Strong understanding of manufacturing processes'' scientific and technical aspects.Proficiency in English communication.On a personal level, you are an experienced, open-minded professional who thrives on collaboration. Building strong, productive relationships with external partners is key, and excellent communication and interpersonal skills are essential for success in driving innovation and excellence in our global projects.About the DepartmentThe Fill & Finish Expansions team is part of the newly established Fill & Finish area, working to increase production capacity across Novo Nordisk to ensure high-quality products for patients now and in the future.Working at Novo NordiskWe don''t wait for change; we drive it. As a dynamic company in a rapidly evolving industry, we embrace experimentation and strive for excellence. We are committed to developing our people and seizing opportunities across research, development, manufacturing, marketing, and salesall to improve patient care.Deadline27 March 2025We are committed to an inclusive recruitment process, celebrating diversity and ensuring equality of opportunity for all applicants. At Novo Nordisk, we aim to be the best company for the world, achieved through talented employees with diverse perspectives, backgrounds, and cultures. Together, we''re life-changing.#J-18808-Ljbffr