Sr. System Validation, Platform Qualification Engineer
hace 4 días
Santiago de Compostela
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.
