Location:Barcelona area, Spain (Hybrid)Start Date:January 2027About the RoleWe are looking for 2+ yearComputer System Validation (CSV)to join a leading global pharmaceutical company. This position sits within the IT organization and plays a key role in ensuring GxP-regulated systems and projects are delivered in a validated state.The successful candidate will work closely with project teams, quality stakeholders, and IT leadership to drive validation activities across critical systems and strategic digital transformation initiatives.This is a long-term opportunity at Oxford Integral Resources Life Sciences with the potential to transition into a permanent internal role within our client.ResponsibilitiesLead Computer System Validation activities for GxP-regulated systems.Ensure projects are delivered in a compliant and validated state.Author and execute validation documentation, including:Validation PlansIQ/OQ/PQ ProtocolsTraceability MatricesValidation ReportsExecute and coordinate testing activities.Manage change controls and validation lifecycle activities for more than 20 GxP systems.Conduct periodic reviews and system assessments.Collaborate with Quality Assurance, IT, Engineering, and business stakeholders.Support regulatory inspections and audit readiness activities.Provide guidance on CSV and Data Integrity best practices.Key ProjectsThe role will support multiple high-impact initiatives,



including:PAS-X implementation and migration projectsLIMS implementations and enhancementsAdditional regulated IT and digital transformation projects within Manufacturing and Quality environments.RequirementsMust HaveExperience inComputer System Validation (CSV)within a pharmaceutical, biotech, or regulated life sciences environment.Knowledge of GxP regulations and computerized system compliance requirements.Experience with validation lifecycle management.Experience creating and executing validation protocols and documentation.Knowledge of Change Control, CAPA, and Risk Management processes.Strong stakeholder management and communication skills.Nice to HaveExperience with PAS-X, Veeva, LIMS, MES, ERP, or other validated systems.Familiarity with Annex 11, GAMP 5, FDA 21 CFR Part 11, and Data Integrity requirements.Project leadership experience.What We OfferLong-term strategic assignment within a leading pharmaceutical company.Opportunity to work on large-scale digital transformation initiatives.Exposure to multiple regulated systems and business-critical projects.Strong career development potential with possible future internalization.Collaborative environment with training and support available for high-potential candidates.KeywordsComputer System Validation | CSV | GxP | GAMP5 | Annex 11 | FDA 21 CFR Part 11 | Veeva | PAS-X | LIMS | Validation Lead | Data Integrity | Pharma | Biotechnology | Life Sciences | Quality Systems | Change ControlThis version is optimized for LinkedIn Recruiter and should attract both senior CSV Specialists and Validation Leads.#J-18808-Ljbffr

📌 Computer System Validation (Madrid)
🏢 Oxford Global Resources
📍 Madrid