Validation Senior Engineer

Bepc Inc. - Business Excellence Professional Consulting; Guadalupe; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

BEPC Inc. - Business Excellence Professional Consulting busca un Ingeniero de Validación Senior para liderar estrategias de validación de procesos, equipos y sistemas en entornos de dispositivos médicos regulados.

El rol implica planificar y ejecutar DOE, aplicar Lean y Six Sigma y apoyar proyectos desde la planificación hasta la ejecución. Se requiere experiencia en IQ/OQ/PQ, CSV, TMV y SAT, además de habilidades de presentación ante clientes y conocimiento profundo de GMP y GDP.

Formación

• Ingeniería requerida; maestría es un plus.
• 4–5 años de experiencia en la industria médica.
• Buenas habilidades de presentación ante grupos/clientes.
• Desarrollo de experimentos factoriales (DOE) requerido.
• Conocimientos avanzados de Lean.
• Conocimiento intermedio de Six Sigma, DMAIC y Kaizen.
• Conocimientos intermedios de Gestión de Proyectos.
• Conocimientos avanzados de estadística.
• Alta competencia en inglés.

Responsabilidades

• Dar apoyo técnico para validaciones: IQ, OQ, PQ y CSV.
• Desarrollar y ejecutar protocolos de TMV y SAT.
• Realizar experimentos en la fase de pre-validación.
• Asegurar que las validaciones se realicen conforme a GMP y GMP.
• Crear formularios para mantenimiento y calibración.

Conocimientos

Presentation skills

English proficiency

Lean

Six Sigma

DMAIC

Kaizen

Educación

Engineering degree

Master's degree preferred

Descripción del empleo

Validation Senior Engineer BEPC Inc. - Business Excellence Professional Consulting Guadalupe, N.L., Guadalupe (municipio), N.L.; Estado de Nuevo León, MX

Descripción del trabajo

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe. At BEPC Inc., we are looking for a Senior Validation Engineer with deep expertise in process, equipment, and computer systems validation, including IQ/OQ/PQ, CSV, TMV, and SAT. This role will lead validation strategies, execute Design of Experiments (DOE), apply Lean and Six Sigma methodologies, and support validation projects from planning through execution in regulated medical device environments.

KEY RESPONSIBILITIES

• Provide technical engineering support for validations, write, and execute Installation Qualification (IQ) protocols, and provide data to write completion reports for assigned validations.
• Provide technical engineering support for validations, write, and execute Operational Qualification (OQ) protocols, and provide data to write completion reports for assigned validations.
• Provide technical engineering support for validations, write, and execute Performance Qualification (PQ) protocols, and provide data to write completion reports for assigned validations.
• Provide technical engineering support for validations, write, and execute Computer Systems Validation (CSV) protocols.
• Provide technical engineering support for validations, write, and execute Test Method Validation (TMV) protocols.
• Provide technical engineering support for validations, write, and execute SAT (Site Acceptance Testing) validation protocols, and provide data to write completion reports for assigned validations.
• Responsible for running experiments during the pre-validation phase, run other experiments as needed.
• Ensure that assigned validation activities are performed in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP).
• Demonstrate sufficient knowledge in validation skills, GMP, Good Documentation Practices (GDP).
• Responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.

QUALIFICATIONS

• ~ Engineering Degree (master’s in science is a plus)
• ~4 – 5 years of experience in medical industry
• ~ Good presentation skills before groups/clients.
• ~ Solid skills in developing Factorial Experiments (DOE´s) - Must
• ~ Extensive knowledge in Lean.
• ~ Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
• ~ Intermediate knowledge of Project Management.
• ~ Extensive knowledge of statistics.
• ~ Advanced English proficiency