CSV Specialist

CSV Specialist – Medior📍Walloon Region, BelgiumAre you passionate about computerized systems validation and eager to grow in a demanding pharmaceutical environment? Join Nalys, an engineering consultancy specialized in life sciences and advanced technologies.As part of a strategic project for one of our major pharmaceutical clients, we are looking for a CSV Specialist – Medior to strengthen our quality and compliance team. This role offers the opportunity to contribute to high-value projects while benefiting from Nalys’ collaborative culture and support.Main ResponsibilitiesAs a Nalys consultant, you will work on-site with our client to:Lead validation projects: including process equipment, automated lab instruments, and computerized systems, in compliance with GAMP5, GMP, and 21 CFR Part 11 standardsDeliver validation documentation: such as project plans, impact assessments, user requirements, test strategies, risk assessments, protocols, SOPs, periodic reviews, Excel validations, and decommissioning proceduresEnsure regulatory complianceCollaborate with internal teams as production, IT, and laboratory departmentsYour ProfileYou hold a Bachelor’s or Master’s degree in IT, science, or equivalent with experienceYou have a minimum of 5 years experience in a GMP-regulated industry with strong CSV expertiseYou are familiar with GMP computerized systems such as LIMS, CDS, BMS, JDE, SAPYou already worked with Excel validation in a pharmaceutical environmentExcellent communication, verbal and writtenYou are able to work independently and manage multiple tasks under deadlinesYou are a good teamplayer.The Recruitment ProcessBy applying for the CSV Specialist position, you will go through the following steps:Application review by Olivia Braszko, Talent Acquisition Specialist at NalysOn a second step, a technical interview with our Technical DirectorThe final interview will take place with Jimmy Rousseaux, ou BU Director.Ready to contribute to impactful pharmaceutical projects while growing in a dynamic and people-focused company? Join Nalys and make a difference!