Sr. System Validation, Platform Qualification Engineer - Remote

Role: System Validation, Platform Qualification Location: Spain(100% Remote) Client: Infosys Sal: Market Range Permanent full-time position ¿Tiene lo que se necesita para triunfar?La siguiente información debe ser leída atentamente por todos los candidatos.Requirements and number of open positions 3-5 years- 2 Positions in Open 5-10 Years- 2 Positions in Open 10+ years - 2 Positins in Open Role Overview 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.Key Responsibilities - Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review) - Drive validation strategy for enterprise programs across regions (Europe/Global) - Manage validation teams, allocate work, and ensure timely delivery - Act as primary point of contact for client stakeholders and leadership - Lead governance, status reporting, and escalation management - Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report) - Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+) - Manage quality processes (Deviation, CAPA, Change Control) - Support regulatory audits and inspection readiness - Mentor and coach junior resources, build capability within the team - Drive continuous improvement and standardization of validation processes Managerial Skills - Team leadership and people management - Stakeholder and client relationship management - Program and project management for global validation initiatives - Risk and issue management with mitigation planning - Resource planning and capacity management - Governance, reporting, and executive communication - Budget awareness and delivery management - Cross-functional coordination across IT, QA, Business and Vendors Required Skills & Competencies - 10+ years of experience in Life Sciences CSV/CSA - Exposure to cloud/SaaS validation - Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.) - understanding of SDLC and validation lifecycle - Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.) - Experience in risk-based validation and CSA approach - Experience working with US and European clients and regulated environments - Strong documentation, communication, and leadership skills.xhfqzwm Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.

La siguiente información debe ser leída atentamente por todos los candidatos.Requirements and number of open positions 3-5 years- 2 Positions in Open 5-10 Years- 2 Positions in Open 10+ years - 2 Positins in Open Role Overview 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. Key Responsibilities - Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review) - Drive validation strategy for enterprise programs across regions (Europe/Global) - Manage validation teams, allocate work, and ensure timely delivery - Act as primary point of contact for client stakeholders and leadership - Lead governance, status reporting, and escalation management - Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report) - Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+) - Manage quality processes (Deviation, CAPA, Change Control) - Support regulatory audits and inspection readiness - Mentor and coach junior resources, build capability within the team - Drive continuous improvement and standardization of validation processes Managerial Skills - Team leadership and people management - Stakeholder and client relationship management - Program and project management for global validation initiatives - Risk and issue management with mitigation planning - Resource planning and capacity management - Governance, reporting, and executive communication - Budget awareness and delivery management - Cross-functional coordination across IT, QA, Business and Vendors Required Skills & Competencies - 10+ years of experience in Life Sciences CSV/CSA - Exposure to cloud/SaaS validation - Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.) - understanding of SDLC and validation lifecycle - Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.) - Experience in risk-based validation and CSA approach - Experience working with US and European clients and regulated environments - Strong documentation, communication, and leadership skills. xhfqzwm Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.