At BEPC Inc., we are looking for a Validation Engineer II with strong expertise in IQ/OQ execution, Computer Systems Validation (CSV), Test Method Validation (TMV), and pre-validation experimentation. This role will lead complex validation activities, support calibration and preventive maintenance documentation, and apply statistical analysis and continuous improvement methodologies (Six Sigma, DMAIC, Kaizen) in regulated manufacturing 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 Computer Systems Validation (CSV) protocols. Provide technical engineering support for validations, write and execute Test Method Validation (TMV) protocols.



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.

MAIN QUALIFICATIONS: Engineering Degree (master’s in science is a plus) 3 - 5 years of experience in the manufacturing industry and/or 3 – 4 years of experience in medical industry Good presentation skills before groups/clients. Intermediate knowledge of statistics. Intermediate knowledge in Six Sigma, DMAIC and Kaizen. Intermediate English level (reading and writing) with intermediate conversation skills.

MXOPS

Job Type: Contract

Pay: $100.00 - $200.00 per month

Work Location: In person

📌 Ingeniero de Validación II - (Medical Devices) (México)
🏢 Bepc
📍 México