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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
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.
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