Remoto: Teletrabajo

Role: System Validation, Platform Qualification Location: Spain(100% Remote)Client: InfosysSal: Market RangePermanent full-time positionAsegúrese de leer la descripción completa a continuación y, si confía en que cumple todos los requisitos, envíe su solicitud de inmediato.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 ResponsibilitiesLead 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 deliveryAct as primary point of contact for client stakeholders and leadershipLead governance, status reporting, and escalation managementAuthor 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 readinessMentor and coach junior resources, build capability within the teamDrive continuous improvement and standardization of validation processesManagerial SkillsTeam leadership and people managementStakeholder and client relationship managementProgram and project management for general validation initiativesRisk and issue management with mitigation planningResource planning and capacity managementGovernance, reporting, and executive communicationBudget awareness and delivery managementCross-functional coordination across IT, QA, Business and VendorsRequired Skills & Competencies10+ years of experience in Life Sciences CSV/CSAExposure to cloud/SaaS validationStrong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.)understanding of SDLC and validation lifecycleUnderstanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.)Experience in risk-based validation and CSA approachExperience working with US and European clients and regulated environmentsStrong documentation, communication, and leadership skills. xbhjioeHay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.

📌 Sr. System Validation, Platform Qualification Engineer (Baiona)
🏢 Nityo Infotech
📍 Baiona