CSV Specialist – Medior
đź“ŤWalloon Region, Belgium
Are 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 Responsibilities
As 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 standards
* Deliver validation documentation: such as project plans, impact assessments, user requirements, test strategies, risk assessments, protocols, SOPs, periodic reviews, Excel validations, and decommissioning procedures
* Ensure regulatory compliance
* Collaborate with internal teams as production, IT, and laboratory departments
Your Profile
* You hold a Bachelor’s or Master’s degree in IT, science, or equivalent with experience
* You have a minimum of 5 years experience in a GMP-regulated industry with strong CSV expertise
* You are familiar with GMP computerized systems such as LIMS, CDS, BMS, JDE, SAP
* You already worked with Excel validation in a pharmaceutical environment
* Excellent communication, verbal and written
* You are able to work independently and manage multiple tasks under deadlines
* You are a good teamplayer.
The Recruitment Process
By applying for the CSV Specialist position, you will go through the following steps:
* Application review by Olivia Braszko, Talent Acquisition Specialist at Nalys
* On a second step, a technical interview with our Technical Director
* The 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!