Lead Validation Engineer — Medical Devices, GMP & DOE

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 500.000 - 800.000; Jornada completa

Descripción de la vacante

BEPC Inc. Mexico, a division of BEPC Incorporated, seeks a Senior Validation Engineer to lead validation strategies in regulated medical device environments. You will execute IQ/OQ/PQ, CSV, TMV, and SAT protocols, run DOEs, and apply Lean and Six Sigma methodologies while ensuring GMP/GDP compliance.

The role emphasizes planning through execution, data-driven validation, and collaboration with cross-functional teams in automotive and medical device contexts.

Formación

• Engineering degree; master's degree is a plus.
• 4–5 years of experience in medical industry.
• Solid skills in developing Factorial Experiments (DOE).
• Extensive knowledge in Lean.
• Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
• Intermediate knowledge of Project Management.

Responsabilidades

• Lead validation strategies and execute IQ/OQ/PQ and CSV protocols.
• Execute TMV and SAT validation activities and support completion reports.
• Perform pre-validation experiments and other needed tests.
• Ensure GMP and GDP compliance across validation activities.
• Create calibration and preventive maintenance records documentation.

Conocimientos

DOE development

Lean

Six Sigma (DMAIC)

Project management

Presentation skills

Educación

Engineering Degree

Master’s in science (plus)

Descripción del empleo

BEPC Inc. Mexico, a division of BEPC Incorporated, seeks a Senior Validation Engineer to lead validation strategies in regulated medical device environments. You will execute IQ/OQ/PQ, CSV, TMV, and SAT protocols, run DOEs, and apply Lean and Six Sigma methodologies while ensuring GMP/GDP compliance.

The role emphasizes planning through execution, data-driven validation, and collaboration with cross-functional teams in automotive and medical device contexts.