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Ingeniero de Validaciones

Req #: JR - 072673 Location Tijuana, Baja California, México Job Category: Quality Control Date Posted: 06/09/2022

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Ingeniero de Validaciones

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Principales Actividades y Responsabilidades:

  • Vigilar el cumplimiento de los requisitos de la regulación FDA de países a donde se exporta el producto, estándares internacionales (ISO 9001/ISO 13485) y requisitos corporativos con especial atención al 21CFR 820.22, 30, 65, 70, 75, 90, 100, 130, 184, and 198.
  • Análisis estadístico de la variación de los procesos, control de procesos/productos, análisis de riesgo de las familias de producto de la planta, implementación de acciones de mejora resultante del análisis de datos de la experiencia del producto interna y externa.
  • Asegurar el cumplimiento a la normatividad aplicable para mantener el estatus de validación.
  • Realizar las actividades del proceso de calificación y validación.
  • Calificar equipos y sistemas críticos usados en la manufactura de procesos.
  • Dar cumplimiento al Plan Maestro de Validación vigente.
  • Revisar protocolos y reportes de validación.
  • Recopilar información anexa a los protocolos de validación.
  • Elaborar y mantener actualizados los procedimientos aplicables a los procesos de calificación y validación de acuerdo a los estándares corporativos y la legislación nacional e internacional.
  • Formar parte de la estructura en la toma de decisiones concernientes al cumplimiento regulatorio y de estándares de calidad en todas las operaciones antes descritas.
  • Apoyo directo en las inspecciones regulatorias.
  • Aplicar y seguir los lineamientos de EHS de acuerdo a los procedimientos establecidos, estándares y normas oficiales mexicanas.
  • 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.
  • Además de en caso de tener participación como aprobador de calidad tiene la responsabilidad de asegurar que las investigaciones hayan tenido una adecuada investigación de causa y que los cierres de investigación o acciones hayan sido ejecutados correctamente, cumplan los requerimientos del sistema y sean documentados apropiadamente.


Escolaridad:

Nivel licenciatura en las áreas de Químico Industrial, Ingeniero Químico, Ingeniero Industrial o disciplinas similares.

Experiencia:

  • 2 -3  años de experiencia en Validaciones, calificación de equipos de manufactura y sistemas críticos.
  • 2-3 años de experiencia mínima en la Validación de procesos, métodos analíticos y validación de sistemas computarizados.
  • 2 - 3 años de experiencia mínima en procesos de aseguramiento de calidad, ejecución de auditorías y aplicación de procesos de fabricación.

Conocimientos:

  • Dominio de inglés avanzado.
  • Conocimiento de sistemas computacionales, estadística, calificación de equipos.
  • Conocimiento en la validación de sistemas computarizados y procesos, control ambiental y aplicación de regulación local e internación aplicada a los procesos de control de documentos y auditorias.
  • Conocimiento en el anejo de estadística básica, metodología Six Sigma y manejo de evaluación de riesgo.
  • Conocimiento de laboratorio químico y microbiológico.
  • Sistemas ERPs: SAP, TcU, JDEdwards.
  • MDSAP. (Medical Device Single Audit Program) (Deseable)

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

072673

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Join Our Talent Community

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