Engineer II, Process
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Job Description
Engineer II, Process
Propósito del puesto
Brindar soporte técnico a los procesos de manufactura, asegurando su eficiencia, estabilidad y cumplimiento de los estándares de calidad y regulatorios. Será responsable de ejecutar actividades de validación, mejora y optimización de procesos dentro de un entorno de manufactura regulado.
Responsabilidades principales
- Brindar soporte técnico y seguimiento a procesos de manufactura.
- Desarrollar y ejecutar validaciones de procesos y equipos (IQ/OQ/PQ), incluyendo protocolos y reportes.
- Analizar datos y desempeño de procesos para identificar desviaciones y oportunidades de mejora.
- Implementar iniciativas de mejora continua y optimización de procesos.
- Participar en cambios de procesos, equipos o parámetros mediante Change Control.
- Apoyar investigaciones de desviaciones, análisis de causa raíz y CAPAs.
- Mantener actualizada la documentación técnica relacionada con procesos y validaciones.
- Participar en la implementación o transferencia de nuevos procesos, productos y equipos.
- Trabajar en conjunto con Manufactura, Calidad e Ingeniería para asegurar el cumplimiento de los requerimientos técnicos y regulatorios.
Requisitos
- Ingeniería Industrial, Mecánica, Electromecánica, Electrónica, Mecatrónica, Química, Biomédica o afines.
- 2 a 3 años de experiencia en ingeniería de procesos, manufactura o posiciones similares, preferiblemente en industrias reguladas.
- Experiencia indispensable en validaciones de procesos y/o equipos, idealmente IQ/OQ/PQ.
- Experiencia en análisis y mejora de procesos de manufactura.
- Conocimientos de Change Control, CAPA y documentación técnica.
- Inglés conversacional.
- Capacidad analítica y habilidad para trabajar con equipos multidisciplinarios.
- Disponibilidad para trabajar presencialmente en Haina. Transporte disponible.
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