Sr. System Validation, Platform Qualification Engineer
hace 19 horas
León
Role: System Validation, Platform Qualification Las cualificaciones, habilidades y toda la experiencia relevante necesaria para este puesto se pueden encontrar en la descripción completa a continuación. Location: Spain (100% Remote) | Salary: 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 positions 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+), • 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 xcskxlj coordination across IT, QA, Business and Vendors, • 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 of 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 #J-18808-Ljbffr