Packaging Engineer

Amalie (Hui) Shi

**** * ********** **. *** **** 443-***-****

Easton, MD 21601 ******@******.**.***

OBJECTIVE

Biomedical Engineer with FDA regulation and cGMP knowledge and ASQ Certified Six Sigma Yellow Belt EDUCATION

JOHNS HOPKINS UNIVERSITY, Whiting School of Engineering, Baltimore, Maryland Master of Science in Biomedical Engineering: December 2019 Thesis: The Use of 3D-Printed Phantoms for Evaluating CT Image Quality GEORGIA INSTITUTE OF TECHNOLOGY, Atlanta, Georgia

Bachelor of Science in Biomedical Engineering with Highest Honors: December 2016 EXPERIENCE

Packaging Engineer APHENA PHARMA SOLUTIONS January 2020 - Present

• Execute and deliver project specification to the customer

• Use tech transfer package to design formulations and processes for lab-scale commercial products, including four (4) cosmetic creams, two

(2) E-liquids, and one (1) electrolyte drink

• Develop and author master batch record (MBR), engineering scale-up (ENG), process performance qualification (PPQ), process verification (PV) protocols and reports for the blending, packaging, filling, serialization, and cleaning processes

• Apply root cause analysis (RCA) to troubleshoot Sartorius blending batching system, Optel serialization system, Pouchmaster form-fill- seal packaging system in downtime and complete corrective actions and preventive actions (CAPA)

• Coordinate the communication between the cross-functional team (QA/QC, project management (PM), operations, and microbiology and analytical chemistry lab) in the pharmaceutical manufacturing process

• Document the development and field execution of Installation & Operational Qualification (IQOQ) test protocols, preventive maintenance (PM) and set-up instructions

• Set up preventive maintenance schedule, procure materials that support production and arrange raw material delivery and final product shipment

JOHNS HOPKINS UNIVERSITY, Baltimore, MD

Medical Image Analyst ADVANCED IMAGING ALGORITHMS & INSTRUMENTATION LAB April 2018 - Dec 2019

• Designed 3D-printed vascular stenosis, liver, and lung nodule CT target with Solidworks, MATLAB, and AutoCAD.

• Molded, machined, and cast anthropomorphic phantoms and spherical targets for CT image quality assessment.

• Assessing the image quality of the different CT modalities with the designed phantoms using radiomics to extract & characterize features with MATLAB.

Graduate Research Assistant MYOCARDITIS LABORATORY January 2018 - April 2018

• Programmed ANCOVA with MATLAB to prove the significance of a hypothesis-driven clinical data sets

• Annotated human heart samples with a high-resolution microscope and characterized the distribution of cardiac cells and invading autoimmune cells.

• Administered therapeutic agents through different routes; performed survival animal surgeries in creating heart failure and cardiac arrest models in mice/rats (intubation/mechanical ventilation and arterial/vein cannulation).

• Harvested heart and spleen and cultured cell in vitro; purified and isolated cells and prepared the histology sample of the heart; performed molecular biology experiments such as real-time PCR, ELISA, flow cytometry, Western Blot, and immunostaining. SKILLS

Software: R, Python, MATLAB, SolidWorks, AUTOCAD, LATEX, Minitab, JMP, Microsoft Word, PowerPoint, Excel, Visio, and Project, Illustrator, EndNote, LaTeX, ChemBioDraw

Activities: Vice President at Georgia Tech Women’s Chorus, Secretary at Biomedical Research Opportunities Society, Staff Writer at Pioneer Publication

Instrumentation: Oscilloscope, Function Generator, Digital Multimeter, NI myDAQ PUBLICATIONS

[1]. Shi, H., Gang, G., Li, J., Liapi, E., Abbey, C., Stayman, JW., Performance Assessment of Texture Reproduction in High-Resolution CT, SPIE 2020 conference proceeding

[2]. Li, J., Gang, G., Shi, H., Stayman, JW., 3D-printed Texture Phantoms for Assessment of High-Resolution CT, AAPM 2019 annual meeting presentation

[3]. Shi, H., Lyle, M., Turtill, C., Nichols, R., Positive force feedback may ameliorate muscle weakness, 2017 SfN’s 47th annual meeting poster

[4]. Lyle, M., Shi, H., Anderson, H., Rapsas, B., Nichols, R., Behavioral adaptations during downslope walking after cross-reinnervation of medial gastrocnemius and the pretibial flexors, 2017 SfN’s 47th annual meeting poster

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