Computer System Validation
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Estamos buscando un(a) Computer System Validation (CSV) Engineer / Specialist para apoyar la validación y gestión del ciclo de vida de sistemas computarizados dentro de un entorno regulado GxP . Esta posición será responsable de asegurar que los sistemas cumplan con los requisitos regulatorios, estándares de data integrity , calidad y cumplimiento durante todo su ciclo de vida. El profesional seleccionado trabajará de manera colaborativa con equipos de IT, Engineering, Automation, Quality Assurance, Manufacturing, Laboratory y proveedores externos. Responsabilidades principales Desarrollar y ejecutar documentación de CSV y protocolos de validación. Apoyar la implementación, actualización, modificación y retiro de sistemas. Aplicar principios de GAMP 5, GxP/cGMP, FDA 21 CFR Part 11, EU Annex 11 y ALCOA+ . Realizar risk assessments, validation testing, impact assessments y regression testing . Brindar apoyo en deviations, CAPAs, investigations, audits e inspecciones regulatorias. Colaborar con equipos de IT, Engineering, Automation, Quality Assurance, Manufacturing, Laboratory y proveedores externos. Apoyar la gestión del ciclo de vida de los sistemas computarizados y asegurar el cumplimiento de los requerimientos de validación. Trabajar con sistemas como MES, SCADA, HMI, PLC, DCS, BMS/EMS, LIMS, CDS, QMS, ERP y manufacturing databases . Requisitos Bachillerato o Licenciatura en Engineering, Computer Science, Information Technology, Life Sciences o un campo relacionado. Experiencia trabajando con sistemas computarizados en industrias pharmaceutical, biotechnology, medical device u otras industrias reguladas. Conocimiento de CSV, Software Development Life Cycle (SDLC), GxP/cGMP, FDA 21 CFR Part 11, GAMP 5 y ALCOA+ . Experiencia desarrollando validation protocols y documentación técnica. Excelentes habilidades de comunicación y redacción técnica. Capacidad para trabajar eficazmente con equipos multidisciplinarios. Deseable experiencia con: Kneat Rockwell/Allen-Bradley Siemens Schneider Ignition AVEVA/Wonderware DeltaV PI ValGenesis Veeva Tipo de puesto: Tiempo completo Lugar de trabajo: Híbrido en Carolina, PR *
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