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**:
- Engineering Degree (master’s in science is a plus) **4 - 5 years of experience in medical industry** Proven experience in Software Development Life Cycle (SDLC) validation. **Experience working with ETQ plataform** Good presentation skills before groups/clients. **Advanced English proficiency (Must)**
MXOPS
Pay: $100.00 - $200.00 per hour
Work Location: In person

📌 Senior Validation Engineer - 30236 (Ciudad Juárez)
🏢 Bepc
📍 Ciudad Juárez