Ingeniero de Validacion II

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 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:

• Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Support validation activities and pre-validation experiments within manufacturing processes.
• Generate validation reports and maintain accurate technical documentation.
• Support in the execution of experiments during the pre-validation phase.
• Utilize Minitab and statistical tools for data analysis and process evaluation.
• 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).
• Support continuous improvement initiatives and process optimization activities.
• 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
• Knowledge and hands-on 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 level (reading and writing) with intermediate conversation skills.