Validation Engineer II

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 420.000 - 640.000; Jornada completa

Descripción de la vacante

BEPC Inc. invites a Validation Engineer II to join our fast-growing team in the Ciudad Juárez area.

The role focuses on development and execution of IQ and OQ protocols, supporting pre-validation experiments, and preparing validation completion reports to ensure GMP/GDP regulatory compliance in manufacturing and medical device environments. We seek an Engineering degree holder with 2–4 years in manufacturing or 2–3 years in the medical industry, plus solid presentation skills, intermediate

Formación

• Engineering degree required.
• 2–4 years of experience in the manufacturing industry and/or 2–3 years in the medical industry.
• Intermediate English (reading and writing) with intermediate conversation skills.
• Knowledge of GMP and GDP concepts is beneficial.

Responsabilidades

• Provide technical engineering support for validations, write IQ protocols and contribute data for completion reports.
• Write and execute OQ protocols and support completion reports for assigned validations.
• Assist in pre-validation experiments and ensure activities comply with GMP.

Conocimientos

Presentation skills

Statistics

Six Sigma DMAIC Kaizen

English (Intermediate)

Educación

Engineering degree

Descripción del empleo

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 Mexicoand around the globe.

BEPC Inc. is seeking a Validation Engineer II to join our fast-growing team of consultants in the Ciudad Juárez area. This role provides advanced technical engineering support for validation activities, including the development and execution of IQ and OQ protocols, support during pre-validation experiments, and preparation of validation completion reports. The position plays a key role in ensuring compliance with GMP, GDP, and current regulatory requirements within manufacturing and 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.
• Support in the execution of experiments during the pre-validation phase.
• 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 basic 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.

MAIN QUALIFICATIONS:

• Engineering Degree
• 2 - 4 years of experience in the manufacturing industry and/or 2 – 3 years of experience in medical industry
• Good presentation skills before groups/clients.
• Intermediate knowledge of statistics.
• Basic knowledge of Six Sigma, DMAIC and Kaizen.
• Intermediate English level (reading and writing) with intermediate conversation skills.