p Role: System Validation, Platform Qualification /pp Location: Spain(100% Remote) /pp Client: Infosys /pp Sal: Market Range /pp Permanent full-time position /p p Requirements and number of open positions /p p3-5 years- 2 Positions in Open /pp5-10 Years- 2 Positions in Open /pp10+ years - 2 Positins in Open /p p Role Overview /pp We 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. /p p Key Responsibilities /pp• Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review) /pp• Drive validation strategy for enterprise programs across regions (Europe/Integral) /pp• Manage validation teams, allocate work, and ensure timely delivery /pp• Act as primary point of contact for client stakeholders and leadership /pp• Lead governance, status reporting, and escalation management /pp• Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report) /pp• Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+) /pp• Manage quality processes (Deviation, CAPA, Change Control)



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

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