Senior Validation Engineer

• Dec 2021 - Present

Engineer III

• Apr 2016 - Dec 2021

• Developed validation protocols, reports, and validation master plans (IQ / OQ / PQ and Cleaning Validation) • Analyzed sample results in relation to cleaning validation acceptance criteria (i.e. conductivity, endotoxin, bioburden, TOC limits) • Utilized various project management tools to track progress of multiple project assignments • Generated, tracked, and investigated protocol deviations and CAPAs • Engaged with cross-functional departments to determine RCAs and corrective actions • Prepared and reviewed validation packages (i.e. developing data trends, good documentation practice) • Performed engineering tests and analyzed test data to recommend remediations to existing systems • Executed temperature mapping and steam testing protocols using Kaye Validator • Redlined P&IDs to provide As-Built drawings for TOP packages Show less

Validation Engineer

• Dec 2014 - Aug 2015

• Prepared technical reports, summaries, and protocols • Redlined piping and instrumentation diagrams for revision purposes • Performed field verification of equipment and components in comparison to vendor documentation • Generated and executed commissioning and qualification protocols (i.e. IV/OV, IQ/OQ/PQ) related to process systems and equipments • Generated and prepared equipment identification and calibration forms • Documented experiments and results in engineering protocols using good documentation practices Show less

Air Resources Technician II

• 2014 - 2014

• Reviewed and processed applications of portable engines and equipment registration packages • Managed company accounts within the PERP database • Assisted engineers in generating registration documents and registration stickers • Reviewed and processed applications of portable engines and equipment registration packages • Managed company accounts within the PERP database • Assisted engineers in generating registration documents and registration stickers