Experteer Overview
In this role you will drive computer system validation (CSV) for Roche’s GxP and non-GxP platforms, shaping validation strategy, plans, and documentation. You will work across cross-functional teams to ensure systems are qualified, compliant, and audit-ready, supporting patient safety and high-quality products. You’ll serve as a CSV subject-matter expert for audits and continuous improvement initiatives, enabling efficient system validation across product lines. This position offers the opportunity to influence regulatory readiness, collaborate globally, and contribute to Roche’s mission of accessible healthcare.

Compensaciones / Incentivos
• Define validation/qualification strategy and deliverables for GxP computerized systems
• Review and develop validation and qualification plans and reports; ensure readiness for go-live
• Verify testing plans and records; provide consultancy on deviations and corrective actions
• Support deviation investigations, root cause analysis, and CAPA definitions
• Act as CSV subject-matter expert for audit/inspection preparation and execution




• Maintain validated state of systems and keep them audit-ready
• Lead and support periodic system reviews
• Drive continuous improvement through frameworks, tools, and process optimization
• Provide training and share validation/quality knowledge

Responsabilidades
• 6+ years in IT u0026 Software Validation (CSV/CSA, GAMP) in pharma
• Leading validation/qualification for projects and system maintenance
• Authoring and reviewing qualification deliverables, plans, reports, and registries
• Maintaining and supporting applications under global audits and inspections
• Knowledge of CSV regulations/guidance (FDA CFR 21 Part 11, Annex 11, EU GMP Annex 1)
• Experience with EDMS (Veeva) and ALM tools (ServiceNow, JIRA)
• Strong risk assessment and collaboration across cross-functional teams
• Good command of English, effective communicator

Requisitos principales
• Attractive benefits
• business travel opportunities

📌 Validation Lead - RDT Engineering Excellence & Experience (Madrid)
🏢 Roche
📍 Madrid