Validation Engineer III (Medical Industry)

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 Mexico and around the globe.

At BEPC Inc., we are looking for a Validation Engineer III 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.

QUALIFICATIONS :

• Engineering Degree (master’s in science is a plus)
• 3 – 4 years of experience in medical industry
• Good presentation skills before groups/clients.
• Intermediate knowledge in statistics (Cpk, PPK, DOE´s)
• Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
• Upper-Intermediate English proficiency