Michelle Brown

Commissioning, Qualification, and Validation (Cqv) Engineer @Eli Lilly and Company

Durham, NC, US

Supervise contractor access to clean manufacturing spaces, ensuring adherence to gowning and controlled-area protocols.• Oversee the preparation and installation of OEM packaging equipment, ensuring compliance with operational standards.• Lead equipment qualification (URS/FAT/IQ/OQ/PQ) for OEM packaging systems, ensuring regulatory compliance.• Monitor and maintain controlled-area requirements for tools and materials during equipment installation.• Develop, review, and gain stakeholder approval of User Requirements Specifications (URS) to define system and equipment needs. • Coordinate and oversee Factory Acceptance Testing (FAT), ensuring that vendor‑supplied equipment meets all functional and quality criteria.• Plan, execute, and document Installation Qualification (IQ) activities to verify proper installation of equipment and systems. • Conduct Operational Qualification (OQ) testing to confirm that equipment operates according to its intended operating ranges. • Lead Performance Qualification (PQ) protocols to validate consistent, reproducible performance under real‑world conditions. • Review and approve Master Batch Records, executed records (IQ/OQ/PQ logs), and technical documentation for FDA compliance.• Validate and file all Executed Records—IQ/OQ/PQ logs, FAT reports, and related testing documentation—to ensure traceability.• Author, review, and approve technical protocols (validation, calibration, cleaning) and their corresponding summary reports. • Manage change controls: assess impact, draft change requests, secure approvals, and ensure implementation in accordance with SOPs.

Durham Technical Community College

Certificate: Aseptic Gowning, Clean Room Techniques, BioWork, BioWork

University of North Carolina at Greensboro

B.A, Psychology

North Carolina Central University

Master of Library & Information Science - MLIS, Information Science- Biomedical Informatics