At BEPC Inc., we are looking for a
Senior Validation Engineer
with deep expertise in process, equipment, and computer systems validation, including IQ/OQ/PQ, CSV, TMV, and
SDLC.

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.

• Develop, review, and execute Computer Software Validation (CSV) documentation aligned with SDLC principles.

• Ensure validation activities comply with Software Development Life Cycle (SDLC) requirements and regulatory standards.

• Experience using the ETQ platform for managing quality events,



including Nonconformances (NCRs), CAPAs, and quality-related activities.

• 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, 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.

MAIN QUALIFICATIONS:

• Engine

📌 Senior Validation Engineer SDLC (México)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 México