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# Sr. System Validation, Platform Qualification Engineer - Remote

- **Company:** Infosys
- **Location:** Marín, Spain (Remote available)
- **Contract:** Temporary to permanent
- **Skills:** Software as a Service, Data Integrity, Laboratory Information Management Systems, Systems Development Life Cycle, Software Systems, System Testing, Iq/oq/pq, Enterprise Software Applications, SAP S/4HANA, VeevaVault, GXP
- **Published:** August 5, 2026
- **Apply:** https://www.buscojobs.com.es/sr-system-validation-platform-qualification-engineer-remote-en-marin-ID-365397438

## About the Role

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.

## Description

Role: System Validation, Platform QualificationLocation: Spain(100% Remote)Client: InfosysSal: Market RangePermanent full-time positionTodos los posibles candidatos deben leer con atención los siguientes detalles de este trabajo antes de presentar una candidatura.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 xbhjioe 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.


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