PpFortil 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. /p h3YOUR ROLE /h3 pAs part of projects in the pharmaceutical industry, you will act as a bCSV Specialist /b, ensuring that computerized systems comply with regulatory requirements. /p pYour main responsibilities will include: /p ul liExecute and lead Computer System Validation (CSV) activities in compliance with GAMP5, GMP, and 21 CFR Part 11. /li liPrepare and manage validation documentation: validation plans, impact assessments, URS, risk assessments, test strategies, protocols, SOPs, and periodic reviews. /li liValidate computerized systems and equipment (laboratory, manufacturing, IT systems). /li liEnsure data integrity and perform Excel validation in a GMP environment. /li liCollaborate with cross‑functional teams (IT, Quality, Manufacturing, Laboratory). /li liEnsure compliance with US, EU, and ICH regulations. /li liContribute to continuous improvement of validation processes. /li /ul h3PROFILE /h3 ul liBachelor’s or Master’s degree in Computer Science, Engineering, or related scientific field (or equivalent experience in GMP environment). /li li3 to 7 years of experience in Computer System Validation (CSV) within the pharmaceutical or biotech industry. /li liStrong knowledge of regulations: GAMP5, GMP, FDA 21 CFR Part 11, ICH, EU guidelines. /li liFamiliarity with systems such as LIMS, CDS, BMS, SAP, JDE. /li liUnderstanding of project lifecycle and software validation processes (SDLC). /li liProfessional level of English (written and spoken). /li /ul pSoft skills: /p ul liStrong attention to detail and rigor /li liAbility to work cross‑functionally /li liAutonomy and ability to manage multiple priorities /li liExcellent communication and presentation skills /li /ul h3What We Offer /h3 ul liOpportunity to work on high‑value projects in the pharmaceutical industry /li liA challenging and dynamic environment alongside technical experts /li liFast‑track skill development in validation and regulatory compliance /li liFortil culture focused on performance, autonomy, and career growth /li /ul /p #J-18808-Ljbffr