Summary

Experience

Mar 2021Present

Senior Validation EngineerThermo Fisher Scientific

Greenville, NC

Jun 2017Feb 2021

Validation EngineerCatalent Pharma Solutions

Morrisville, NC

Projects

Jan 2022Nov 2022

Automated Bioreactor Qualification Project

Mar 2020Jan 2021

Data Integrity Program Implementation

Education

Aug 2013May 2017

North Carolina State UniversityB.S. Biomedical Engineering

Raleigh, NC

Publications

Aug 2023

Risk-Based Approaches to Computer System Validation in Aseptic Processing

Apr 2021

Optimizing Equipment Qualification Protocols for Accelerated Biologics Manufacturing

Nov 2019

Impact of Data Integrity on GMP Compliance: A Case Study

Skills

Equipment Qualification (IQ/OQ/PQ)Process ValidationCleaning ValidationComputer System Validation (CSV)Test Method ValidationQuality Management Systems (QMS)GxP (GMP, GLP, GCP)FDA 21 CFR Part 11/210/211EU Annex 11/15ISO 13485Risk Assessment (FMEA)Audit Support

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