Senior Validation Engineer - Quality (Medical Devices)

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

Descripción de la vacante

BEPC Inc. in Mexico seeks a Validation Engineer III – Quality to execute and support validation activities in regulated medical device manufacturing environments. You will work with Engineering, Manufacturing, Quality, R&D, and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, GDP, and QMS requirements.

The role covers IQ/OQ/PQ, CSV, TMV, MVP/MVI/SVMP documentation, risk assessments, DOE, and data analysis to improve process robustness and facilitate inspections and audits.

Formación

• Bachelor's Degree in Engineering or a related field.
• 3–5 years of experience in validation, quality or manufacturing engineering in a regulated environment.
• Experience with IQ/OQ/PQ execution and documentation (FDA 21 CFR Part 820, ISO 13485, GMP, GDP, QMS).
• Experience or working knowledge of CSV and TMV validations.
• Familiarity with MVP, MVI, SVMP documentation and validation lifecycle management.
• Knowledge of risk-based validation methodologies.
• Working knowledge of DOE and statistical analysis.
• Experience supporting CAPA, deviations, non-conformances, and change control.
• Familiarity with calibration and preventive maintenance documentation.
• Knowledge of Lean Manufacturing, Six Sigma, DMAIC, and continuous improvement.

Responsabilidades

• Execute and support validation activities for manufacturing processes, equipment, test methods, and computerized systems.
• Write, review, and execute OQ, PQ, CSV, TMV, FAT, SAT.
• Support MVP, MVI, SVMP documentation and validation lifecycle.
• Develop validation protocols, reports, and other technical documents per FDA/ISO/QMS requirements.
• Support DOE and statistical analyses for validation.
• Participate in risk assessments, feasibility studies, and experimental runs.
• Coordinate validation deliverables to meet timelines and regulatory requirements.
• Provide support during audits and regulatory inspections.
• Support deviation investigations, CAPAs, non-conformances, and change control.
• Apply Lean/Six Sigma methods to improve validation efficiency.

Conocimientos

Advanced English proficiency

Strong communication

Strong written documentation

Collaboration and teamwork

Project management basics

Lean Manufacturing

Six Sigma

DOE and statistical analysis

Educación

Bachelor's Degree in Engineering

Descripción del empleo

BEPC Inc. in Mexico seeks a Validation Engineer III – Quality to execute and support validation activities in regulated medical device manufacturing environments. You will work with Engineering, Manufacturing, Quality, R&D, and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, GDP, and QMS requirements.

The role covers IQ/OQ/PQ, CSV, TMV, MVP/MVI/SVMP documentation, risk assessments, DOE, and data analysis to improve process robustness and facilitate inspections and audits.