▪ Represent validation department as cross-function team lead and SME for product portfolios, new product introduction, sustaining projects, and continuous improvement▪ In charge of managing a team to perform validation activities for Validation Plans and IQ/OQ/PQ protocols▪ Perform gap analysis review of Corporate and Site Level Quality/Validation documents and procedures▪ Author of Site Level validation procedures and documents including commissioning plan, validation plan, FAT/SAT, IQ/OQ/PQ, traceability matrix, summary report template, and deviation report template▪ Validation Team Lead and SME for ten automation lines used to manufacture medical devices for diabetic care and needleless drug delivery devices▪ Responsible for developing, authoring, executing, and analyzing validation activities (VP/FAT/SAT/IQ/OQ/PQ) for multiple automated equipment for different factories▪ Responsible for developing, authoring, executing, and analyzing validation activities (IQ/OQ/PQ) for injection molding processes for molded components used to manufacture reconstitution devices, drug delivery pipettes, and single-dose prefilled cartridges for use in medical treatments▪ Perform data analysis for injection molding processes using statistical methods

▪ Developed, authored, and executed IQ/OQ/PQ protocols for aseptic blow/fill/seal equipment, formulation tanks, and post-packaging equipment▪ Supported room commissioning and qualification activities for new manufacturing suites▪ Analyzed and summarized results for vapor phase hydrogen peroxide studies used during product sterility testing▪ Executed temperature mapping for environmental/temperature controlled warehouse rooms, autoclaves, and laboratory refrigeration equipment

▪ Authored and executed software validation (IQ and PQ) for statistical software (MINITAB 15 and SDI Software Tools 3) and IBM Rational ClearQuest used in development and testing of company-wide medical devices▪ Leveraged Six Sigma methodology DMADV in implementing 300 test cases into HP Quality Center for the validation and verification functionality testing of a then still-in-development small volume infusion pump▪ Supported and collaborated in the development, revision, and modification of the Design for Reliability (DFR) plan, the Reliability Analysis Report, and associated reliability prediction models generated using RELEX for a new infusion pump▪ Supported the Design Transfer Team as validation liaison for cross-function teams▪ Coordinated and facilitated all activities (Team Lead) for CAPA-issued engineering change requests across multiple business functions with a team comprised of seven colleagues

▪ Authored, executed, analyzed data collected, and summarized results for PQ and PPQ protocols as part of a company-wide Process Validation Remediation project▪ Developed and executed PQ and PPQ tests involving pressure and vacuum, occlusion, fluid flow, and device/needle length measurements for endoscopic products▪ Investigated and summarized results of the extrusion annealing process to determine whether a correlation existed between annealing and extrusion length of the device▪ Developed, executed, and summarized results for test method validation protocols▪ Developed and executed PQ and PPQ tests for bond pull, tip pull, inner/outer diameter (ID/OD) and length/spacing measurements for Nasobiliary and Biliary stents

DiGiorno Self-rising Crust Pizza• Perform study to gage sodium perception amongst consumers by observing sodium reduction in chief pizza components.• Collaborate with statistician to develop design of experiment for sodium reduction study.Jack’s Pizza crust• Research sodium reduction in pizza crusts and its effects on manufacturing process issues.• Successful plant trial on Jack’s pizza crust in a worst case scenario setting, with no observable process issues present.California Pizza Kitchen• Assist in commercialization of two new SKUs under California Pizza Kitchen brand by representing R&D function at weekly cross-functional team meetings.• Lead pizza formulation development for new SKUs, produce pizzas in pilot plant, and achieve understanding in pizza formulation and nutrition drivers during formulation process.• Schedule and facilitate team showings for pizzas developed in pilot plant, using feedback to refine pizza formulations.

• Design and development of ingredient formulation to incorporate Omega-3 fatty acids into Kraft Mayo Light as part of a Health and Wellness Initiative, ensuring recommended amount meets requirements set by the Food & Drug Administration (FDA).• Development, execution, and analysis of pilot test study to determine optimal amount of antioxidants to mitigate the oxidation of Kraft Mayo Light.• Research the benefits of adding Omega-3 fatty acids into Kraft Light Done Right Salad Dressings.