Senior Validation Engineer - Medical devices

BEPC has a Ciudad Juarez area OPEN POSITION for Senior Validation Engineer to join our fast-growing team of consultants! This role is responsible will be working on the shop floor to define the impact of the variant part and components, directly working with associates, group leaders and supervisors. • 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 Total Maintenance 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, 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) Engineering Degree (master’s in science is a plus) • Responsible for the execution of validation, including the creation of forms to create calibration At least 5 years of experience in medical industry as validation/process engineer. Good presentation skills before groups/clients. Solid skills in developing Factorial Experiments (DOE). Extensive knowledge in Lean. Intermediate knowledge of Six Sigma, DMAIC and Kaizen. Intermediate knowledge of Project Management. Extensive knowledge in statistics. Advanced English level (reading and writing) with intermediate conversation skills.

Location: México, MX

Posted Date: 4/26/2025