Senior Validation Engineer - Medical Devices & CSV

BEPC Inc. - Business Excellence Professional Consulting; Chihuahua; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

BEPC Mexico, a division of BEPC Incorporated, seeks a Validation Engineer – Quality to execute and support validation activities within regulated medical device manufacturing environments. This role will cover IQ/OQ/PQ, CSV, TMV, and validation documentation.

You will collaborate with Engineering, Manufacturing, Quality, R&D, and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, GDP and QMS requirements, and support audits and CAPA processes.

Formación

• Bachelor's degree in engineering or related field required.
• 3–5 years in validation/quality engineering in a regulated environment (medical devices preferred).
• Experience with IQ/OQ/PQ, CSV, TMV, and validation lifecycle documents.

Responsabilidades

• Execute and support validation for processes, equipment, test methods, and computerized systems.
• Write, review, and execute IQ/OQ/PQ, CSV, TMV, FAT/SAT as required.
• Maintain MVP, MVI, SVMP documentation and validation lifecycle artifacts.

Conocimientos

Advanced English

Technical writing

Project management

Communication skills

Collaboration

Presentation skills

Educación

Bachelor's Degree in Engineering or related technical field

Herramientas

CSV Validation

TMV Validation

IQ/OQ/PQ execution

Descripción del empleo

BEPC Mexico, a division of BEPC Incorporated, seeks a Validation Engineer – Quality to execute and support validation activities within regulated medical device manufacturing environments. This role will cover IQ/OQ/PQ, CSV, TMV, and validation documentation.

You will collaborate with Engineering, Manufacturing, Quality, R&D, and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, GDP and QMS requirements, and support audits and CAPA processes.