| Puesto | Sr. System Validation, Platform Qualification Engineer - ibiza |
| Publicado | 04 Aug 2026 |
| Expirado | 03 Sep 2026 |
| Empresa | Nityo Infotech |
| Ubicación | Balearic Islands | ES |
| Tipo de Contrato | Full Time |
Última información laboral de Nityo Infotech para la posición de Sr. System Validation, Platform Qualification Engineer - ibiza. If the Sr. System Validation, Platform Qualification Engineer - ibiza vacante en Balearic Islands coincide con tus calificaciones, envía tu solicitud o currículum directamente a través del portal actualizado de Jobkos.
Ten en cuenta que aplicar a un trabajo puede no ser siempre fácil, ya que los candidatos deben cumplir con ciertos requisitos establecidos por la empresa. Esperamos que esta oportunidad en Nityo Infotech para la posición de Sr. System Validation, Platform Qualification Engineer - ibiza se ajuste a tu perfil profesional.
Role: System Validation, Platform Qualification
Ubicación: España(100% Remote)
Client: Infosys
Sal: Market Range
Permanent full-time Puesto
Requirements and number of open Puestos
3-5 years- 2 Puestos in Open
5-10 Years- 2 Puestos 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.
Después de leer y comprender los criterios y requisitos mínimos explicados en la información del trabajo Sr. System Validation, Platform Qualification Engineer - ibiza at the office Balearic Islands anterior, completa de inmediato tus archivos de solicitud, como carta de presentación, CV (Hoja de Vida), copia de diploma y otros suplementos. Envía a través del enlace Siguiente Página abajo.
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