Sr. System Validation, Platform Qualification Engineer - Remote

Role: System Validation, Platform QualificationLocation: Spain(100% Remote)Client: InfosysSal: Market RangePermanent full-time positionAsegúrese de leer la descripción completa a continuación y, si confía en que cumple todos los requisitos, envíe su solicitud de inmediato.Requirements and number of open positions3-5 years- 2 Positions in Open5-10 Years- 2 Positions in Open10+ years - 2 Positins in OpenRole OverviewWe 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 processesManagerial 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 VendorsRequired 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. xqysrnhHay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.

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., 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. xqysrnh Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.