Validation Engineer - Quality | Medical Devices & CSV

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 480.000 - 700.000; Jornada completa

Descripción de la vacante

BEPC Inc. in Mexico seeks a Validation Engineer - Quality to execute and support validation activities in regulated medical device manufacturing environments.

You will lead IQ/OQ/PQ protocols, CSV and TMV efforts, and contribute to MVP/MVI/SVMP lifecycle management. Collaborating with Engineering, Manufacturing, Quality, R&D and Regulatory teams, you will ensure compliance with FDA, ISO 13485, GMP and GDP, maintain QA documentation, and drive risk-based validation and continuous improvement

Formación

• Bachelor's Degree in Engineering or related technical field.
• 3-5 years of experience in validation, quality/ manufacturing engineering or related activities in a regulated environment.
• Practical experience with IQ/OQ/PQ execution and documentation.
• Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, GMP, GDP, and QMS.
• Experience with CSV and TMV validations and knowledge of MVP/MVI/SVMP lifecycle.
• Knowledge of risk-based validation methodologies and DOE with statistical analysis.
• Experience supporting CAPA, deviations, non-conformances, and change control.
• Familiarity with calibration documentation and Lean Six Sigma, DMAIC concepts.
• Strong technical writing, communication, organization and presentation skills.
• Advanced English proficiency, written and verbal.

Responsabilidades

• Execute and support validation activities for manufacturing processes, equipment, test methods, and computerized systems.
• Write, review, and execute OQ, PQ, CSV, TMV, FAT and SAT protocols and reports.
• Support MVP, MVI, and SVMP documentation and validation lifecycle management.
• Develop validation documentation in accordance with FDA, ISO 13485, GMP, GDP and QMS.
• Collaborate with cross-functional teams (Engineering, Manufacturing, Quality, R&D, Regulatory).
• Apply risk-based validation approaches and participate in risk assessments and DOE activities.
• Support audits and regulatory inspections; assist in deviation investigations and CAPAs.

Conocimientos

Quality engineering

Validation

Technical writing

Project management

Lean Six Sigma

Educación

Bachelor's Degree in Engineering

Herramientas

CSV

TMV

DOE

Descripción del empleo

BEPC Inc. in Mexico seeks a Validation Engineer - Quality to execute and support validation activities in regulated medical device manufacturing environments.

You will lead IQ/OQ/PQ protocols, CSV and TMV efforts, and contribute to MVP/MVI/SVMP lifecycle management. Collaborating with Engineering, Manufacturing, Quality, R&D and Regulatory teams, you will ensure compliance with FDA, ISO 13485, GMP and GDP, maintain QA documentation, and drive risk-based validation and continuous improvement