• Worked thoroughly with filling technicians and mechanics to revise operational SOPs for the Flex-50 vial filling machine to accurately reflect current procedures. Prepared and revised SOPs and logbooks for product refrigerators and freezers.• Prepared Engineering Study (ES) for the Flex-50 to optimize recipes and test the filling speed and accuracy of larger tubing sizes. Assisted in the execution of the ES and prepared the summary report. Results from the ES showed that with the larger tubing, the machine output can be more than doubled without any impact to fill accuracy.• Assisted in preparing a user administration SOP and protocol for CSV testing of the Flex-50 and participated in CSV execution.• Performed an assessment on the qualification documentation of critical equipment and utilities including compressed air, WFI, HVAC, Building Management System, Lighthouse Monitoring System, and Blue Mountain Regulatory Asset Manager.• Managed CAPAs and CAPA execution activities for the Facilities Department and helped drive overdue CAPAs to closure. Performed investigations and root cause analysis for several deviations for the Facilities Department.• Prepared IQOQ protocol for glassware washer and PQ protocols for purified water system, checkweigher, labeler, and mixers. Reviewed qualification protocols for several equipment such as autoclaves and mixers.• Revised the PQ protocol for the Flex-50 and assisted in the execution of the PQ. Prepared the PQ summary report and used the data gathered from the PQ to establish and justify an in-process sampling plan.• Prepared URSs for vial filling machines, labeling machines, and packaging machines for the client’s manufacturing suite expansion project.

Under AVS, worked with the following clients in the biotech and pharmaceutical industry:ImprimisRx (Ledgewood, NJ)March 2022 - presentNational Heath Research Institutes, Taiwan January 2022 - March 2022• Prepared URS for Manufacturing Execution System (MES) for the client’s electronic batch record upgrade project.Genentech, Inc. (Vacaville, CA)November 2019 - December 2021Adimmune, Inc. (Taichung, Taiwan)June – November 2019• Reviewed/revised Validation Master Plans (VMPs) for the client’s new syringe filling and packaging line.• Prepared URSs for packaging equipment including syringe assembly machine, thermoformer, cartoner, casepacker, and drug traceability serialization system.• Prepared impact and risk assessments for packaging equipment, buffer prep and formulation systems, and CIP system.EirGenix, Inc. (Xizhi Facility in New Taipei City, Taiwan)February – May 2019• Reviewed/revised Cleaning VMP, Cleaning Validation protocols, and cleaning SOPs for process equipment including glassware washer, chromatography skids, and ultrafiltration system. These tasks helped the client establish a sitewide plan and standard for Cleaning Validation that can also be applied to their new manufacturing facility in Zhubei, Taiwan.EirGenix, Inc. (Zhubei Facility in Zhubei, Taiwan)July 2018 – January 2019• Prepared IQOQ protocols and summary reports for Emerson DeltaV DCS and AHUs for the client’s new manufacturing facility. Prepared PQ protocol and summary report for the QC laboratory AHU.• Prepared Requirements Traceability Matrixes for process equipment such as bioreactors and chromatography skids which provide evidence that all the client’s requirements for each equipment have been tested.

• Revised functional specs to include process descriptions for equipment phases and created flowcharts to illustrate phase functionality for downstream cell culturing process equipment including pool tanks, ultrafiltration system, bulk dispensing unit and fill station, and freeze-thaw skids.• Wrote process descriptions for each line of code in the automation pseudocode pin charts for downstream equipment. The updates to the functional specs and pin charts allowed people without a background in automation to easily understand how each equipment phase works.• Maintained tracking spreadsheet for change records and action items for a new product. Redlined and updated functional specs and pin charts for chromatography, pool tanks, viral filtration, and ultrafiltration systems to incorporate changes made for the new product.• Analyzed existing operator prompts to simplify and streamline prompting for the Emerson DeltaV/Syncade DCS/MES upgrade project. Reviewed control module documents provided by Emerson to confirm that the functionality matches the existing Honeywell system.

• Oversee and assist students during their training to ensure their safety and prevent damage to the tools or machines.• Help students find and check out tools, answer questions, and provide machining assistance.• Perform routine maintenance on the lathes and mills such as oiling and checking coolant levels.• Help clean and organize the shop and examine the condition of various cutters and tools.