Emily W. Email & Phone Number

United States

• Designed and standardized work plan templates for preventive maintenance, recommending calibration intervals in alignment with NIST standards and process specifications for Good Manufacturing Practices (GMP) equipment, thereby enhancing reliability and performance.• Analyzed HEPA filter service reports for critical parameters such as airflow, velocity, air changes per hour, airborne particle counts, air pressure differentials, and filter leakage, ensuring compliance with ISO standards for cleanroom environments.• Diligently ensured regulatory compliance through the systematic resolution of deviations, proactive management of change controls, and meticulous drafting and revision of Standard Operating Procedures (SOPs) to uphold quality assurance.• Strategically proposed, managed, and executed multiple Capital Expenditure (CAPEX) projects, focusing on utility process enhancements to optimize operational efficiency.• Executed Failure Mode and Effects Analyses (FMEA) and Instrument Criticality Assessments (ICA) for site equipment, thereby enhancing risk management protocols and ensuring operational integrity.• Maintained and developed detailed system specification packages, delivering recommendations for clean utility systems, including Water for Injection (WFI), Reverse Osmosis Deionized Water (RODI), Clean Steam, and Compressed Dry Air (CDA), while adhering to ISPE guidelines.• Developed and implemented comprehensive commissioning, qualification, training, and periodic reviews for various systems, ensuring rigorous compliance with cGMP and regulatory standards

Morrisville, North Carolina, United States

• Drafted and refined asset record, work orders, and scheduling event documentation within Blue Mountain Regulatory Asset Manager (BMRAM) to ensure accurate tracking and operational efficiency.• Created comprehensive troubleshooting guides for engineering teams, significantly reducing machine downtime and enhancing operational reliability.• Initiated, investigated, and resolved Trackwise deviation records for assets identified as out of tolerance, ensuring compliance with quality standards and facilitating corrective actions.• Developed a strong understanding of cGMP, SOPs, 5S methodologies, and Six Sigma practices in a pharmaceutical environment, observing continuous improvement initiatives.

Raleigh, North Carolina, United States

Master Of Science - Ms, Chemical Engineering

Bachelor'S Degree, Bioengineering And Biomedical Engineering

Bachelor'S Degree, Bioengineering And Biomedical Engineering