Staff Validation Engineer (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 Staff Validation Engineer with deep expertise in end-to-end validation strategies, including process, equipment, computer systems, and maintenance validations. This role will lead DOE development, Lean Six Sigma initiatives, and project-level execution, while collaborating closely with Operations, Design, and Engineering teams to ensure products meet regulatory, quality, and design requirements.

KEY RESPONSAIBLITIES:

• 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 Test Method 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, running 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.
• Support for the development of the production of new products.
• Responsible for the analysis and development of manufacturing functions, capabilities and facilities necessary to produce the client's product.
• Work with the Operations and Design team to verify and validate that the product under development meets regulatory and design requirements.

QUALIFICATIONS:

• Engineering Degree (master’s in science is a plus)
• 6 – 9 years of experience in medical industry (Must)
• Good presentation skills before groups/clients.
• Solid skills in developing Factorial Experiments ( DOE ).
• Strong knowledge in Lean Six Sigma, DMAIC and Kaizen.
• Strong knowledge in Project Management.
• Extensive knowledge of statistics.