Sr. System Validation, Platform Qualification Engineer - Remote

pRole: System Validation, Platform Qualification /pbr /Desplácese hacia abajo para obtener una visión general completa de lo que requerirá este trabajo.¿Es usted el candidato adecuado para esta oportunidad?br /pLocation: Spain(100% Remote) /ppClient: Infosys /ppSal: Market Range /ppPermanent full-time position /ppRequirements and number of open positions /pp3-5 years- 2 Positions in Open /pp5-10 Years- 2 Positions in Open /pp10+ years - 2 Positins in Open /ppRole Overview /ppWe 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./ppKey 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/Global) /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 /ppManagerial 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 /p xhfqzwm p- Cross-functional coordination across IT, QA, Business and Vendors /ppRequired Skills Competencies /pp- 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

br /pLocation: Spain(100% Remote) /ppClient: Infosys /ppSal: Market Range /ppPermanent full-time position /ppRequirements and number of open positions /pp3-5 years- 2 Positions in Open /pp5-10 Years- 2 Positions in Open /pp10+ years - 2 Positins in Open /ppRole Overview /ppWe 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. /ppKey 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/Global) /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 /ppManagerial 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 /p xhfqzwm p- Cross-functional coordination across IT, QA, Business and Vendors /ppRequired Skills Competencies /pp- 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.