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
Job Type: Full-time
Pay: $100.00 - $200.00 per hour
Work Location: In person
