Validation Engineer (Medical Devices)

Bepc Inc. - Business Excellence Professional Consulting; Chihuahua; Presencial; MXN 420.000 - 640.000; Jornada completa

Descripción de la vacante

BEPC Inc. en Chihuahua, México, busca un Ingeniero de Validación para apoyar las actividades de validación en un entorno de dispositivos médicos regulado. Desarrollarás, ejecutarás y documentarás protocolos para asegurar el cumplimiento de requisitos de calidad y regulatorios.

Colaborarás con Producción, Calidad e Ingeniería, gestionando documentación conforme a GDP y apoyando auditorías internas y externas. Se requiere experiencia en validación IQ/OQ/PQ y英语.

Formación

• Bachelors in Engineering or related technical field.
• Experience in medical device industry mandatory.
• Hands-on experience with IQ/OQ/PQ protocols.
• Knowledge of validation principles in regulated environments.
• Experience preparing technical reports and controlled documents.
• Ability to analyze data, investigate deviations and solve problems.
• Strong organizational skills and attention to detail.
• English proficiency to understand/prepare technical documentation.

Responsabilidades

• Develop, execute, and document IQ/OQ/PQ protocols.
• Prepare validation plans, protocols, reports and supporting documents.
• Coordinate validation activities for equipment, processes and lines.
• Analyze validation results and ensure acceptance criteria are met.
• Investigate protocol deviations and support CAPA implementation.
• Collaborate with Manufacturing, Quality, Engineering and cross‑functional teams.
• Support equipment installation, process changes, transfers and new products.
• Maintain validation documentation per GDP and regulatory requirements.
• Provide validation support during audits.

Conocimientos

IQ/OQ/PQ

English proficiency

Data analysis

Cross-functional collaboration

Documentation

Educación

Bachelor's degree in Engineering

Herramientas

Windchill

Descripción del empleo

Descripción del trabajo

Validation Engineer - Medical Device Industry BEPC Inc. is seeking a qualified Validation Engineer to support validation activities within a regulated medical device manufacturing environment. This position will be responsible for developing, executing, and documenting validation protocols to ensure that manufacturing equipment and processes comply with quality, regulatory, and operational requirements.

Key Responsibilities

• Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Prepare validation plans, protocols, reports, and supporting technical documentation.
• Coordinate validation activities for manufacturing equipment, processes, and production lines.
• Analyze validation results and ensure that all acceptance criteria are successfully met.
• Investigate protocol deviations and support the implementation of corrective actions.
• Collaborate with Manufacturing, Quality, Engineering, and other cross-functional teams.
• Support equipment installation, process changes, product transfers, and new product introductions.
• Maintain complete and accurate validation documentation in accordance with Good Documentation Practices.
• Ensure compliance with applicable medical device quality systems, procedures, and regulatory requirements.
• Provide validation support during internal and external audits, as required.

Mandatory Requirements

• Bachelor's degree in Engineering or a related technical field.
• Professional experience in the medical device industry is mandatory .
• Hands-on experience developing, executing, or documenting IQ, OQ, and PQ protocols .
• Knowledge of validation principles and regulated manufacturing environments.
• Experience preparing technical reports and controlled documentation.
• Ability to analyze data, investigate deviations, and solve technical problems.
• Strong organizational skills and attention to detail.
• Ability to collaborate effectively with cross-functional teams.
• English proficiency sufficient to understand and prepare technical documentation.

Preferred Qualifications

• Experience with process, equipment, or manufacturing validation.
• Knowledge of GMP, Good Documentation Practices, change control, CAPA, risk analysis, and statistical methods.
• Experience with document-control or quality-management systems such as Windchill.
• Experience supporting medical device manufacturing transfers or new product introductions.