Validation Engineer II — IQ/OQ/PQ & GMP Specialist

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; On-site; MXN 240,000 - 360,000; Full time

Job summary

BEPC Inc. is seeking a Validation Engineer II to join our Ciudad Juárez area team. This role provides advanced technical support for validation activities, including developing IQ/OQ protocols, supporting pre-validation experiments, and preparing validation completion reports.

The position ensures compliance with GMP, GDP, and current regulatory requirements in manufacturing and medical device environments, using Minitab for data analysis and contributing to continuous improvement initiatives.

Qualifications

• Engineering degree required.
• 2–4 years of experience in manufacturing and/or 2–3 years in medical industry.
• Experience with IQ, OQ, and PQ validation processes.
• Knowledge of statistical analysis and data interpretation using Minitab.
• Experience performing root cause analysis and validation failure investigations.
• Good presentation skills before groups/clients.
• Intermediate knowledge of statistics.
• Basic knowledge of Six Sigma, DMAIC and Kaizen.
• Intermediate English reading and writing with intermediate conversation skills.

Responsibilities

• Develop, execute, and document IQ, OQ, and PQ protocols.
• Support validation activities and pre-validation experiments.
• Generate validation reports and maintain technical documentation.
• Support during pre-validation experiment execution.
• Utilize Minitab and statistical tools for data analysis and process evaluation.
• Ensure validation activities comply with GMP and GDP requirements.
• Contribute to continuous improvement and process optimization.
• Execute validation, including creation of calibration and preventive maintenance records.

Skills

IQ/OQ/PQ validation processes

Statistics

Root cause analysis

Presentation skills

Six Sigma basics

DMAIC/Kaizen

English - intermediate

Education

Engineering Degree

Tools

Minitab

Job description

BEPC Inc. is seeking a Validation Engineer II to join our Ciudad Juárez area team. This role provides advanced technical support for validation activities, including developing IQ/OQ protocols, supporting pre-validation experiments, and preparing validation completion reports.

The position ensures compliance with GMP, GDP, and current regulatory requirements in manufacturing and medical device environments, using Minitab for data analysis and contributing to continuous improvement initiatives.