Professional Summary
Process Engineer with a quality-focused, detail-oriented mindset. Proven success in: technical writing, deviation investigation, driving process improvement through corrective and preventative actions, experimental design, and data analysis. Strong ability to collaborate and work in a team environment on multi-disciplinary projects.
Education: Bachelor of Science in Chemical Engineering
Northeastern University – Boston, MA August 2013
Member of the American Institute of Chemical Engineers (AIChE)
Massachusetts Institute of Technology EdX May 2016 – August 2016
Completed courses on Astrobiology and The Principles of Biopharmaceutical Manufacturing
Skills
- Accomplished author of Technical Reports, Investigations and CAPAs (Corrective / Preventative Actions)
- GMP Skills: AKTA, Explorer, ELISA, LAL Assay, SDS-PAGE gels, HPLC, Column Chromatography, TFF, UF/DF, UV Absorption, Aseptic and Purification Techniques; Clean Room, Respirator & PAPR Certified
- Computer: JMP 11, Trackwise, MasterControl, LIMS, PI Historian, ASPEN, Microsoft Office
Professional Experience
Par Pharmaceutical – Irvine, CA
Associate Process Engineer October 2016 – Present
- Recipient of the Endo Shining STAR Award for “exceptional and noteworthy contributions to the goals and success of [the] company” for conducting investigations resulting in the release of lots from QA Hold
- Collaborates with Quality Assurance, Analytical Services, Engineering and Manufacturing to conduct and prepare technical investigations on Production Deviations, including evaluating and troubleshooting manufacturing equipment and process issues, conducting interviews, and collecting and analyzing current and historical data in order to determine root cause and drive process improvement through corrective and preventative actions (CAPA)
- Prepares experimental batch records and associated protocols (raw material evaluation protocol, manufacturing process study protocol, intermediate and bulk holding studies) for submission to FDA
- Tracks lifecycle of investigations, and compiles monthly and yearly metrics on Production Deviations
- Reviews and revises Standard Operating Procedures for Biennial review
Pfizer – Andover, MA
Associate Scientist December 2014 – February 2015
- Designed and executed experiments to aid in defining biopharmaceutical manufacturing processes
- Performed chromatography, centrifugation, precipitation, and filtration experiments, an...
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