CSV Specialist

CSV Specialist – Catalent📍 Brussels, BelgiumAbout Nalys Nalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. We partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we combine deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed. Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.The Role & ResponsibilitiesAs a CSV Specialist, you will play a key role in ensuring compliance and integrity of computerized systems within a leading pharmaceutical environment. Your responsibilities will include:Validation Projects: Execute validation activities for process equipment, laboratory instruments, and computerized systems in line with different specific guidelinesValidation Deliverables: Prepare and maintain documentation such as project plans, user requirements, risk assessments, test protocols, SOPs, and periodic reviewsRegulatory Compliance: Ensure adherence to US regulations, and other relevant regulations, as well as EHS requirementsCollaboration & Continuous Improvement: Work closely with manufacturing, IT, and laboratory teams to implement validation programs and foster a culture of continuous improvement.Skills & QualificationsYou hold a Bachelor’s or Master’s degree in Computer Science, STEM, or related scientific field (Alternatively, 5+ years of experience in a CGMP-related industry with CSV expertise)You have a strong knowledge of CSV and IT regulations You are familiar with GMP systems and Excel validation workflowsYou understand Project Management and Software Development Life CyclesExcellent communication, leadership, and problem-solving skillsYou are able to work independently and manage multiple priorities under strict deadlines.The recruitment processAt Nalys, our hiring process is designed to be transparent and engaging:Olivia Braszko, TA Specialist at Nalys, will review your application and schedule an initial screeningA second interview will be held with one of our technical expertsFinal interview with our Business Unit Director, Jimmy Rousseaux.If you’re passionate about compliance and want to contribute to the success of a global pharmaceutical leader, we’d love to hear from you