ppComputerized Systems Validation (CSV) Specialist /p pbBarcelona | Pharmaceutical Industry | Hybrid /b /p pAre you passionate about quality, compliance, and digital transformation within highly regulated environments? /p pWe are looking for an experienced bComputerized Systems Validation (CSV) Specialist /b to join a leading international pharmaceutical company and play a key role in ensuring that critical GxP computerized systems remain compliant, reliable, and inspection-ready throughout their lifecycle. /p h3What you'll be doing /h3 pAs a CSV Specialist, you will act as a trusted expert supporting validation activities across manufacturing, quality, laboratory, and business systems. You'll work closely with cross-functional stakeholders to ensure compliance while enabling innovation and digitalisation initiatives. /p pYour responsibilities will include: /p ul liLeading validation projects for computerized systems from implementation through retirement. /li liDefining validation strategies using risk-based approaches aligned with GAMP 5 principles. /li liDeveloping and reviewing validation documentation, including URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports. /li liSupporting system upgrades, enhancements, infrastructure changes, and periodic reviews. /li liEnsuring compliance with GMP regulations, Data Integrity requirements, Annex 11, and 21 CFR Part 11.



/li liParticipating in audits and inspections as the CSV subject matter expert. /li liManaging validation-related deviations, CAPAs, and change controls. /li liCollaborating with Quality, IT, Manufacturing, Engineering, Laboratory and Regulatory teams. /li liDriving continuous improvement initiatives and supporting digital transformation programmes. /li /ul h3What we’re looking for /h3 ul liPrevious experience in Computerized System Validation within a pharmaceutical, biotechnology, medical device, or other regulated environment. /li liStrong knowledge of GAMP 5, EU GMP Annex 11, Data Integrity (ALCOA+), and 21 CFR Part 11. /li liExperience validating GxP systems such as MES, LIMS, QMS, ERP, SCADA, laboratory systems, or manufacturing applications. /li liUnderstanding of risk-based validation methodologies. /li liExcellent stakeholder management and communication skills. /li liAbility to work effectively across multidisciplinary teams. /li liOpportunity to work with cutting-edge digital and automated systems. /li liExposure to high-impact projects supporting pharmaceutical manufacturing and quality operations. /li liInternational, collaborative, and innovation-driven environment. /li liStrong focus on professional development and continuous learning. /li liCompetitive compensation and benefits package. /li /ul /p #J-18808-Ljbffr

📌 Computerized Systems Validation (CSV) Specialist (Barcelona)
🏢 Oxford Global Resources
📍 Barcelona