Senior Validation Engineer

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.

BEPC has a Ciudad Juarez area OPEN POSITION for Senior Validation Engineer to join our fast-growing team of consultants!

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 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).
• 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)
• 4 - 6 years of experience in the manufacturing industry and/or 5 – 6 years of experience in medical industry
• Good presentation skills before groups/clients.
• Solid skills in developing Factorial Experiments (DOE).
• Extensive knowledge in Lean.
• Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
• Intermediate knowledge in Project Management.
• Extensive knowledge in statistics.
• Advanced English level (reading and writing) with intermediate conversation skills.