Automation Validation Engineer

• Aug 2023 - Present

-Design and develop manufacturing control systems in support of process operations -Interact with client personnel to identify and analyze continuous improvement through automation upgrades risks assessments and participates in Quality/Regulatory audits -Develop and execute validation documents (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA cGMP and GAMP standards, functional and design specifications, and requirements trace matrices -Design, program, test and validate process control automation systems, automation qualification and validation protocols -Manage, document, and implement automation upgrades through changes control procedures -Execute capital projects including: control system software development, control system hardware and network design, MES system implementation, recipe management and user requirement specification development, and process equipment installations -SOP development and training on Automation Systems -Troubleshoot, analyze, and resolve field control system issues -Design, develop, and implement technical solutions by establishing integration strategies, configuring and programming PLCs, DCSs as well as design, build, install and integrate automation control system hardware, panels and field devices Show less

Validation Engineer

• Jan 2022 - Jul 2023

-Supports the execution of small projects or portions of larger projects -Supports the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures -Conducts risks assessments and participates in Quality/Regulatory audits -Develops and executes qualification protocols and final summary reports and participates in commissioning activities -Supports the execution of small projects or portions of larger projects -Supports the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures -Conducts risks assessments and participates in Quality/Regulatory audits -Develops and executes qualification protocols and final summary reports and participates in commissioning activities

Assistant Scientist

• Jan 2021 - Dec 2021

•Performed a variety of sample preparation and analysis procedures to quantitatively measure pharmaceutical/biopharmaceutical compounds in a variety of formulations and biological matrices for stability and analytical testing •Reviewed, interpreted, and analyzed data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) •Executed and trained on routine start-up, shutdown, and maintenance for analytical instrumentation as well as SOPs and regulatory guidelines •Performed self and peer review of data generation for accuracy and compliance with reporting requirements prior to submission to QA and issuance to clients Show less

Math tutor

• Apr 2020 - Jan 2021

-one on one tutor specializing in high school math -homework and test prep -one on one tutor specializing in high school math -homework and test prep

Undergraduate Lab Assistant and Freshman Teaching Assistant

• Jan 2016 - May 2019