JobMesh

CSV Specialist

Novo Nordisk · Brussels, Brussels Capital, BE

CSV Specialist Global Manufacturing & Supply Brussels, Belgium Ensure the quality and safety of life-saving medicines by validating the systems that bring th...

Job description

CSV Specialist Global Manufacturing & Supply Brussels, Belgium Ensure the quality and safety of life-saving medicines by validating the systems that bring them to patients. Join us during an exciting journey at our Brussels sterile manufacturing! Your new role: As a CSV Specialist, you will play a critical role in ensuring the regulatory compliance of computerized systems that support our production operations. Day-to-day your tasks will include: - Executing validation projects for production equipment, laboratory automated instruments, and computerized systems throughout their lifecycle - Creating and supporting validation deliverables including project plans, impact assessments, user requirements, test strategies, risk assessments, protocols, SOPs, and periodic reviews - Contributing to remediation and data integrity projects, ensuring compliance with US, EU, and other international regulatory requirements - Collaborating with production, IT, and laboratory teams to successfully implement validation programs and drive projects forward - Fostering a culture of continuous improvement by identifying process optimization opportunities and actively contributing to their implementation...