Summary
Highly accomplished Validation Engineer with 6 years of experience specializing in GxP environments within the biopharmaceutical and medical device industries. Proven expertise in developing and executing comprehensive qualification protocols (IQ, OQ, PQ) for critical equipment, facilities, utilities, and software systems. Adept at ensuring compliance with FDA regulations, EU Annex 11, and company standards, consistently delivering projects on time and within budget. Seeking to leverage strong analytical skills and a meticulous approach to validation to contribute to innovative manufacturing processes.
Experience
Mar 2021Present
Senior Validation EngineerThermo Fisher Scientific
Greenville, NCJun 2017Feb 2021
Validation EngineerCatalent Pharma Solutions
Morrisville, NCProjects
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, NCPublications
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