Senior validation engineer (medical industry) (Isla Guadalupe)

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 aSenior Validation Engineerwith deep expertise in process, equipment, and computer systems validation, includingIQ/OQ/PQ, CSV, TMV, and SAT. This role will lead validation strategies, execute Design of Experiments (DOE), apply Lean and Six Sigma methodologies, and support validation projects from planning through execution in regulated medical device 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 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 executeTest Method Validation (TMV)protocols.
• Provide technical engineering support for validations, write, and executeSAT (Site 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 – 5 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 of Project Management.
• Extensive knowledge of statistics.

• Advanced English proficiency