Process Validation Engineer
Guarda esta oferta y sigue tu búsqueda
Crea una cuenta gratis para guardar empleos, crear alertas y volver a esta oferta desde tu panel.
Al continuar, aceptas nuestros Términos & Política de Privacidad.
Job Summary
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Process Validation Engineer (Medical Devices) located in Juarez South.
Reporting to the Process Engineering Manager , the Process Engineer’s role involves:
What a typical day looks like:
- Lead validation activities for manufacturing processes, equipment, and systems, including IQ, OQ, PQ, and TMV studies.
- Develop, execute, and approve validation protocols and reports in compliance with FDA, ISO 13485, and internal quality requirements.
- Support New Product Introduction (NPI) activities, ensuring validation deliverables are completed on time.
- Evaluate process changes and determine validation impact assessments and revalidation requirements.
- Perform statistical analysis and capability studies to support process validation and continuous improvement initiatives.
- Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and R&D.
- Conduct risk assessments using PFMEA and other risk management tools.
- Investigate process deviations, nonconformances, customer complaints, and CAPA activities.
- Support internal, customer, and regulatory audits by providing validation documentation and technical expertise.
- Develop and maintain validation master plans, protocols, reports, and associated documentation.
- Identify and implement process improvements that enhance quality, compliance, productivity, and cost efficiency.
The experience we’re looking to add to our team:
- Bachelor’s degree in engineering (Mechanical, Industrial, Biomedical, Manufacturing, Mechatronics, or related field).
- Advanced English communication skills.
- Minimum 3-5 years of experience in medical devices, pharmaceutical, or regulated manufacturing environments.
- Strong experience executing and managing IQ, OQ, PQ, and processing validation activities.
- Proficiency in statistical tools, process capability studies, and data analysis.
- Knowledge of risk management methodologies, including PFMEA.
- Experience with CAPA, nonconformance investigations, and root cause analysis methodologies.
- Strong project management and cross-functional leadership skills.
What you’ll receive for the great work you provide:
- Pantry vouchers
- Saving Fund
- Christmas bonus
- Holiday bonus
- Medical Insurance
- Life Insurance
EM57
Job Category
Production Engineering
Required Skills:
Optional Skills:
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).
-
Process Validation Engineer
Hace 1 día
chihuahua, chihuahua, México Flex Jornada completaFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every...
-
Validation Mechanical Engineer
Hace 13 horas
chihuahua, chihuahua, México Cognizant Jornada completaJob Summary Mechanical Product Validation Engineer with 5-10 years of experience in the medical device industry specializing in cleaning sterilization and reprocessing validation of reusable medical devices. Skilled in feasibility studies validation protocols test method development GR&R risk management (DFMEA/PFMEA) statistical analysis and root cause...
-
Senior Validation Engineer
Hace 13 horas
chihuahua, chihuahua, México BEPC Inc. - Business Excellence Professional Consulting Jornada completaSenior Validation Engineer – Ciudad Juárez BEPC has an open position in the Ciudad Juárez area for a Senior Validation Engineer to join our fast-growing team of consultants. Key Responsibilities Provide technical engineering support for validation activities, including writing and executing Installation Qualification (IQ) protocols, and supplying data...
-
Process Engineer
Hace 21 horas
Chihuahua, Chihuahua, México Johnson Controls Jornada completa## Process EngineerApply: Matamoros-Tamaulipas-Mexico: Full time: Posted Today: WD30283144**Johnson Controls, a global leader in thermal management, mission-critical building systems, energy efficiency, and decarbonization, helps customers use energy more productively, reduce carbon emissions, and operate with the precision and resilience required in...
-
Process Engineer
Hace 13 horas
chihuahua, chihuahua, México Flex Jornada completaFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. To support our extraordinary teams who build great...
-
Validation Engineer
Hace 13 horas
chihuahua, chihuahua, México BEPC Inc. - Business Excellence Professional Consulting Jornada completaBEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe. BEPC Inc. is seeking a...
-
Process Engineer
Hace 2 días
chihuahua, chihuahua, México Grupo TECMA Jornada completaFunciones generales: Analizar los flujos de trabajo dentro y a través de todos los departamentos para determinar cómo toda la empresa puede mejorar en conjunto. Revisar los KPI's y determinar formas de mejorar su capacidad para mantener las operaciones de la compañía. Implementar proyectos de mejora y ahorro de costos. Elaboración de documentos con...
-
Process Engineer
Hace 2 días
chihuahua, chihuahua, México Flextronics - The Flex Company Jornada completaFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every...
-
Validation Engineer I
Hace 13 horas
chihuahua, chihuahua, México BEPC Inc. - Business Excellence Professional Consulting Jornada completaBEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe. BEPC Inc. is seeking a...
-
Senior Hardware Test
Hace 3 horas
Chihuahua, Chihuahua, México Zebra Technologies Jornada completaZebra Technologies is seeking a senior test engineering leader in Chihuahua, Mexico to design tests, define procedures, and oversee daily line testing with our EMS partner. The role requires 6+ years in high-tech manufacturing test or 4+ years with advanced certifications, plus strong English communication and on-site work.You will mentor technicians and...