Cornelious Williams, P.E. Email & Phone Number

Norcross, Ga

=>Technical Writer-Wrote and managed the execution of protocols to determine if lot to lot variation exists for removal torque of filling/capping components -Wrote and managed the execution of airflow visualization studies for controlled manufacturing areas=>Process Validation and Mechanical Design Analyst-Responsible for the validation of equipment used in the production of the Solid Phase product line with capital cost of $400K that produces sales in excess of $3 million annually-Responsible for executing dye immersion and torque relaxation studies on vial components used in the filling process=>Project Manager-Team member of Elevated Investigation for low fill volume complaints with vialed products and particulates in vialed products-Lead Engineer on Elevated Investigation teams responsible for analyzing the mechanical function of the fill and capping process to determine the source of non-viable air action limit excursions and low volume fill complaints-Lead project to re-design procedures for the purchase of capital equipment=>Process Developer-Developed and implemented method to verify and document that facility improvement plans were carried out per the Immucor specifications-Developed and implemented method to validate new filling and capping lines introduced to the manufacturing process-Developed and implemented method to validate new components on all of the vial filling and capping lines at the Norcross, Georgia location-Developed Standard Operating Procedure (SOP) to establish specifications for production equipment purchase

Greater Atlanta Area

-Assisted with the manufacture of transdermal patches that included producing the solvent suspension and processing of the transdermal films that contained either active API or placebo formulations=>Manufacturing Designer-Designed small scale equipment used in the manufacture of numerous cGMP batches of transdermal patches in class 100,000 clean room for indications such as diabetes and Parkinson’s used in Phase I/II clinical trials-Designed and built an array screening device for functional testing of two configurations of the electrical component of the PassPort™ Patch system-Designed a retro-fit for an Ivek slide to accept either an applicator knife or a Meyer rod for solvent casting-Designed an enclosure used to guard a robot used in the assembly of the PassPort™ Patch system=>Process Developer-Developed method to introduce nitrogen to packaging of drug film to extend shelf-life-Conducted process development work to establish parameters for cGMP manufacturing-Wrote development reports that document the steps taken to determine the appropriate conditions for cGMP manufacturing of products used in clinical trials

Fairburn, Ga

=>Project Manager/Designer/Product Developer-Lead Product Development Engineer of filtration media for pools that resulted in annual sales of $300000.-Lead Design Engineer of tooling and a semi-automated rotary table platen heated production tooling for polyurethane potting process for potable water filter production. -Lead Design Engineer of injection molded stopple used in serum samplers for plastic blood collection tubes-Lead Design Engineer of stepper motor driven ball screw linear actuator for pick and place device used in the production of medical devices for transport of tooling.-Lead Design Engineer of IQ/OQ/PQ validated bellows damped molding process that reduced intra-tool part variation of class III medical devices.-Lead Product Development Engineer of FDA regulated plasma blood product filtration device used in the removal of byproducts created as a result of pathogen inactivation and the manufacturing process that generates $75000 in annual sales.-Lead Design Engineer of heat transfer system for extrusion process that increased underwater pellet production of medical device components by 300%.-Lead Design Engineer of tooling for underwater pellet production of EVA used in the manufacture of class III medical devices.-Lead Design Engineer of mold tooling for medical device production that reduced maintenance downtime by 95% by using the DMADV methodology.-Lead Design Engineer of PLC controlled and pneumatically actuated production equipment that increased output of IQ/OQ/PQ validated FDA regulated class III medical devices from 80000 units to 200000 units annually by using the DMAIC methodology. -Lead Product Development Engineer of FDA regulated platelet blood product filtration device used in the removal of byproducts created as a result of pathogen inactivation and the manufacturing process which included extrusion/pelletizing that generates $550000 in annual sales.

Master'S Degree, Materials Engineering

Bachelor Of Science (B.S.), Mechanical Engineering

Bs, Math

Activities and Societies: Alpha Phi Alpha Fraternity Inc.