Eng Validation Projects

hace 6 meses

Tijuana, México BAXTER A tiempo completo

**Vantive: A New Company Built On Our Legacy**

Baxter is on a journey to spin off our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

**Objetivo principal del puesto**:
Administrar, liderar y ejecutar validaciones de proceso y máquina cumpliendo con los requerimientos regulatorios de Calificación de Instalación, Calificación Operacional y Calificación de Desempeño (IQ, OQ, PQ) basado en FDA, QSR, estándar ISO-13485, procedimientos internos y corporativos.

**Principales Actividades y Responsabilidades**:

- Responsable de los procesos de validaciones, dentro del alcance de los proyectos asignados bajo su responsabilidad, incluyendo planeación, desarrollo de protocolos, ejecución e informes para reportar el logro de todas las metas de los proyectos. Las responsabilidades incluyen una transferencia acertada de los procesos hacia las áreas de producción para implementar el nível de desempeño y/o funcionamiento previsto de la producción y en cumplimiento a los procedimientos de validación establecidos. Puede actuar como respaldo del Gerente del área para la generación, mantenimiento y aprobación del plan maestro de validaciones.
- Responsable de desarrollar experimentos, pruebas de ingeniería y DOE, utilizando técnicas y mejores prácticas, para proponer set-up para validaciones de procesos.
- Responsable del desarrollo de procesos de manufactura, coordinando a las diferentes funciones involucradas (Calidad, Producción, Ingeniería), para crear procesos estables y sostenidos para la manufactura de producto.
- Responsable de los procesos de validaciones, incluyendo planteamiento (protocolos de IQ, OQ, PQ), planeación y ejecución (IQ, OQ, PQ, incluyendo reportes) e informes para reportar el logro de todas las metas de los proyectos. Participa en los procesos de validación de software.
- Responsable de la revisión y de desafiar las condiciones propuestas en los protocolos de la validación, reportes de validaciones, proyectos, prueba de ingeniería para asegurar cumplimiento a la calidad establecida y los sistemas reguladores para Baxter Tijuana.
- Responsable de la revisión y reto de las condiciones propuestas en los protocolos de la validación, reportes de validaciones, proyectos, prueba de ingeniería para asegurar cumplimiento a la calidad establecida y los sistemas reguladores aplicables. Puede actuar como respaldo del Gerente del área para la aprobación de protocolos y reportes de validación.
- Responsable (si aplicase) de proporcionar la ayuda y supervisión de personal directo, o personal asignado, dentro del alcance del proyecto asignado.
- Responsable de dar soporte directo o indirecto, en las operaciones diarias en el área de manufactura, para resolver problemas de procesos y corregir desviaciones, para asegurar que las metas de calidad y objetivos se cumplan.
- Responsable de participar activamente en programas de CAPA relacionadas con procesos de manufactura.
- Seguimiento y cierre de No conformidades (NCRs) encontrados en proceso de validación.
- Asegura el cumplimiento de los lineamientos de EHS (seguridad, saluda ocupacional) de acuerdo a los procedimientos establecidos, estándares y normas oficiales mexicanas.
- Provee soporte y entrenamiento a producción de las validaciones efectuadas y procesos liberados.
- Encargado de entregar a manufactura proceso validados y confiables con capacidad de proceso aceptable a largo plazo.
- Encargado junto con Calidad definir los criterios visuales, dimensionales y funcionales del producto y proceso.
- Resultados y responsabilidades adicionales podrán ser asignadas de acuerdo a las necesidades del negocio.
- Utiliza y verifica el equipo de protección personal establecido.
- Apoya el cumplimiento del Sistema de Calidad mediante su participación en investigaciones como dueño asegurando que las actividades relacionadas al seguimiento de un NCR/CAPA son ejecutadas, completadas y documentadas correctamente.

**Escolaridad**:
Nível licenciatura en las áreas de Ingeniería de Manufactura, Bio-medica, Mecánica, Eléctrica, Electrónica, Electromecánica, Industrial o disciplinas similares.

**Experiência**:

- Más de 3 años de experiência probada en el campo o área afín (como Ingeniero de Validaciones, Ingeniero de Procesos, Ingeniero de Manufactura, Ingeniero Industrial o puesto similar)
- Experiência en industria médica o industria con sistemas de regulación.
- Experiên

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