Lead Validation Engineer — Medical Devices, GMP & DOE

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; On-site; MXN 500,000 - 800,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

DOE development

Lean

Six Sigma (DMAIC)

Project management

Presentation skills

Education

Engineering Degree

Master’s in science (plus)

Job description

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.