CSV Specialist

Fortil is an international engineering and technology consulting group, built on an independent model and bringing together over 2,500 employees across 14 countries. Fortil fosters an entrepreneurial mindset and empowers individuals to unlock their full potential. YOUR ROLE As part of projects in the pharmaceutical industry, you will act as a CSV Specialist , ensuring that computerized systems comply with regulatory requirements. Your main responsibilities will include: Execute and lead Computer System Validation (CSV) activities in compliance with GAMP5, GMP, and 21 CFR Part 11. Prepare and manage validation documentation: validation plans, impact assessments, URS, risk assessments, test strategies, protocols, SOPs, and periodic reviews. Validate computerized systems and equipment (laboratory, manufacturing, IT systems). Ensure data integrity and perform Excel validation in a GMP environment. Collaborate with cross-functional teams (IT, Quality, Manufacturing, Laboratory). Ensure compliance with US, EU, and ICH regulations . Contribute to continuous improvement of validation processes. PROFILE Bachelor’s or Master’s degree in Computer Science, Engineering, or related scientific field (or equivalent experience in GMP environment). 3 to 7 years of experience in Computer System Validation (CSV) within the pharmaceutical or biotech industry. Strong knowledge of regulations: GAMP5, GMP, FDA 21 CFR Part 11, ICH, EU guidelines . Familiarity with systems such as LIMS, CDS, BMS, SAP, JDE . Understanding of project lifecycle and software validation processes (SDLC). Professional level of English (written and spoken). Soft

skills:
Strong attention to detail and rigor Ability to work cross-functionally Autonomy and ability to manage multiple priorities Excellent communication and presentation skills WHAT WE OFFER Opportunity to work on high-value projects in the pharmaceutical industry A challenging and dynamic environment alongside technical experts Fast-track skill development in validation and regulatory compliance Fortil culture focused on performance, autonomy, and career growth