Role: System Validation, Platform Qualification brAunque la experiencia profesional y las cualificaciones son clave para este puesto, asegúrese de comprobar si posee las habilidades interpersonales preferibles antes de solicitar, si se requieren.brLocation: Spain(100% Remote)brClient: Infosys brSal: Market Range brPermanent full-time position brRequirements and number of open positions br3-5 years- 2 Positions in Open br5-10 Years- 2 Positions in Open br10+ years - 2 Positins in Open brRole Overview brWe are looking for a highly experienced Validation resource with 10+ years of experience in Computerized System Validation (CSV) within the Life Sciences domain. The candidate will lead end-to-end validation activities for enterprise-level software systems and manage teams, stakeholders, and delivery for global programs. brKey Responsibilities br• Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review)br• Drive validation strategy for enterprise programs across regions (Europe/Global)br• Manage validation teams, allocate work, and ensure timely delivery br• Act as primary point of contact for client stakeholders and leadership br• Lead governance, status reporting, and escalation management br• Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report)br• Ensure compliance with 21 CFR Part 11, EU Annex 11,



Data Integrity (ALCOA+)br• Manage quality processes (Deviation, CAPA, Change Control)br• Support regulatory audits and inspection readiness br• Mentor and coach junior resources, build capability within the team br• Drive continuous improvement and standardization of validation processes brManagerial Skills br• Team leadership and people management br• Stakeholder and client relationship management br• Program and project management for general validation initiatives br• Risk and issue management with mitigation planning br• Resource planning and capacity management br• Governance, reporting, and executive communication br• Budget awareness and delivery management xsgfvud br• Cross-functional coordination across IT, QA, Business and Vendors brRequired Skills Competencies br• 10+ years of experience in Life Sciences CSV/CSA br• Exposure to cloud/SaaS validation br• Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.)br• understanding of SDLC and validation lifecycle br• Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.)br• Experience in risk-based validation and CSA approach br• Experience working with US and European clients and regulated environments br• Strong documentation, communication, and leadership skills.

📌 Sr. System Validation, Platform Qualification Engineer (Monterroso)
🏢 Nityo Infotech
📍 Monterroso