Staff Validation Engineer

Bepc Inc. - Business Excellence Professional Consulting; Chihuahua; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

BEPC Inc. busca un Staff Validation Engineer con experiencia en validación de procesos, equipos y sistemas. Liderará DOE, iniciativas Lean Six Sigma y la ejecución a nivel de proyecto, colaborando con Operaciones, Diseño e Ingeniería para asegurar que el producto cumpla con requisitos regulatorios, de calidad y diseño.

Se valorará Ingeniería y 7–10 años en manufactura o 6–9 años en la industria médica; excelentes habilidades de presentación y conocimiento de GMP.

Formación

• Ingeniería con maestría en ciencias deseable.
• 7–10 años en manufactura o 6–9 años en industria médica.
• Buena habilidad para presentar ante grupos/clientes.
• Sólidos conocimientos en DOE, Lean Six Sigma, DMAIC y Kaizen.
• Gestión de proyectos y habilidades estadísticas.

Responsabilidades

• Proporcionar soporte técnico para validaciones y escribir protocolos IQ, OQ, PQ, CSV, TMV y SAT.
• Ejecutar desarrollo de DOE y reportes de validación.
• Asegurar que las actividades de validación cumplan GMP y DP.
• Realizar experimentos en la fase de pre-validación y otros cuando sea necesario.
• Trabajar con Operaciones y Diseño para verificar que el producto cumpla requisitos regulatorios.

Conocimientos

DOE

Lean Six Sigma

DMAIC

Kaizen

Project Management

Statistics

Presentaciones

Educación

Engineering Degree

Master’s in Science (preferred)

Descripción del empleo

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 Staff Validation Engineer with deep expertise in end-to-end validation strategies, including process, equipment, computer systems, and maintenance validations. This role will lead DOE development, Lean Six Sigma initiatives, and project-level execution, while collaborating closely with Operations, Design, and Engineering teams to ensure products meet regulatory, quality, and design requirements.

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 (Factory Acceptance Testing) validation protocols, and provide data to write completion reports for assigned validations.
• Responsible for running experiments during the pre-validation phase, running 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.
• Support for the development of the production of new products.
• Responsible for the analysis and development of manufacturing functions, capabilities and facilities necessary to produce the client's product.
• Work with the Operations and Design team to verify and validate that the product under development meets regulatory and design requirements.

MAIN QUALIFICATIONS:

• Engineering Degree (master’s in science is a plus)
• 7 - 10 years of experience in manufacturing industry and/or 6 – 9 years of experience in medical industry
• Good presentation skills before groups/clients.
• Solid skills in developing Factorial Experiments (DOE).
• Strong knowledge in Lean Six Sigma, DMAIC and Kaizen.
• Strong knowledge in Project Management.
• Extensive knowledge of statistics.