Jeff Cobos Email & Phone Number

Santa Ana, California, United States

-Provide leadership, mentorship, and support for the Quality Engineering & Validation group, leading equipment & process validations and ongoing support for production operations and quality systems for aseptic injectable drug manufacturing and compounding pharmacy.-Lead for autoclave revalidations, revamped acceptance criteria to align with industry standards, and improved analysis spreadsheet tool to make user-friendly and reduce analysis time.-Revalidation including temperature mapping of warehouses, refrigerators, incubators, depyrogenation ovens & tunnel.-Automated Packaging Line: IOQs for Labeler and Cartoner, automated visual inspection validations (5 stations), PPQ of full integrated packaging line including serialization management ensuring DSCSA compliance, secured FDA approval, ongoing support for production runs.-Validation lead for semi-automated and automated aseptic process simulations/media fills, including protocol design for semi-automated operator and process qualification.-Developed isolator glove management program, including procedures, forms, development and validation of automated pneumatic glove leak testing cycle.-Subject matter expert for calibrations, worked with Quality Manager to hire & train Metrology Technician.-Validation lead for transitioning compounding pharmacy from 503A to 503B designation.-Overhauled cleanroom facility specifications to meet FDA & CA Board of Pharmacy requirements for facility shared between pharmaceutical manufacturer & compounding pharmacy.-Served as SME for multiple topics for inspections by FDA and CA Board of Pharmacy.

Santa Ana, California, United States

Greater Los Angeles Area

Orange County, California Area

I implemented process improvements and conducted root cause investigations for Voyant electrosurgical medical devices in a FDA-regulated environment

Compton, Ca

Provided engineering support for Operations & Maintenance team at waste food-to-energy plant located at Ralphs Grocery Distribution Center, which used anaerobic digestion to generate biogas for utilization in microturbines and boilers.

Greater Los Angeles Area

Coordinated teams of mechanical designers, electrical engineers, pressure vessel/heat exchanger engineers, and equipment buyers to develop specific design and procure engineered equipment for skid based industrial gas screw compressor packages according to customer specifications within allotted schedule and budget constraints.

Rialto Slurrycarb Facility

I was hired initially to aid in the commissioning of new equipment for a large-scale plant expansion. This included cataloging and labeling pipes and valves, directing and supervising maintenance and operating crews in equipment commissioning, and equipment troubleshooting. My final role in the commissioning phase was to collect, interpret, and present data from a 30-day test to establish new operational limits, material consumption rates, and environmental compliance figures for the plant.Since the completion of the plant expansion, my position has transitioned into a much broader role. In addition to day-to-day responsibilities of addressing technical plant maintenance issues and working with vendors to replace and upgrade equipment, I also have managed the last two plant outage projects from scheduling to execution. I have adopted a couple pet projects, including optimizing our biogas flare for environmental compliance and commissioning a heat exchanger to regulate our aerobic digester temperature.

Tutored high school seniors in chemistry, pre-calculus, calculus, and physics at a community educational center.

Instructed high school students in independent sessions in Spanish, geometry, algebra, and calculus.