About
Born and raised in San Francisco, I grew up observing the expansion of the Bay Area's technology hub. I naturally developed a curiosity for figuring out how things worked, often tinkering with devices around the house. My mom would occasionally ask me to fix our home appliances, which I was happy to do, as that fed my interest in technology and the role it played in our lives. I continued to pursue this interest at UC Davis, graduating with a major in Mechanical Engineering and a minor in Technology Management. Throughout my career, I aim to positively impact lives with the work that I do.
Resume
Amy_Phan_Resume.pdfSummary
Amy Phan
Validation Engineer experienced in the Biotechnology and Pharmaceutical industries. A highly motivated self-starter and effective collaborator with technical background that allows for execution of several projects on time while delivering high quality work. Experience working on cleaning and sterilization validation as well as temperature mapping projects with a high degree of competence and knowledge.
- San Francisco Bay Area, CA
- (415) 713-7260
- amyphan16@gmail.com
Areas of Expertise
- Cleaning/Sterilization/Decontamination Validation
- Controlled Temperature Environments
- Temperature Mapping
- Revalidation
- Installation/Performance Qualification
- Data Analysis
- Technical Report Writing
- Knowledge of cGxP Standards
Skills
- Technical: LIMS, Veeva QualityDocs, Lives International Data Loggers, Sensitech, SolidWorks, Fusion 360, MATLAB, Microsoft Office Suite, HTML/CSS (Working Knowledge)
- Personal: Problem-solving, critical thinking, effective communication, integrity, organization, collaboration, attention to detail
- Fabrication: 3D Printing, Mill, Lathe, Drill Press, Band Saw
- Languages: English, Cantonese, Mandarin
Education
Bachelor of Science, Mechanical Engineering
2017 - 2021
University of California, Davis
- Minor: Technology Management
- Activities and Societies: Theta Tau (Co-ed Professional Engineering Fraternity)
- Positions Held: President, New Member Educator, Recruitment Chair, Webmaster
Certification
Engineer In Training (EIT)
2021
California Board for Professional Engineers, Land Surveyors, and Geologists
- License #174045
Professional Experience
Validation Engineer
Sep 2023 - Present
BioMarin Pharmaceutical, Inc.
- Developed and implemented robust cleaning and sterilization protocols for pharmaceutical manufacturing equipment, ensuring compliance with industry standards and regulatory requirements.
- Conducted rigorous validation studies for cleaning, sterilization, and decontamination processes in pharmaceutical manufacturing facilities to maintain product integrity and patient safety.
- Collaborated with cross-functional teams (Quality Assurance, Production, and Automation) to troubleshoot and resolve issues, optimize cleaning and sterilization processes, and enhance overall operational efficiency.
- Performed in-depth analyses to identify and resolve the root causes of deviations detected during testing.
- Authored comprehensive validation documentation, such as protocols and reports, to support regulatory submissions and audits, ensuring thorough documentation and traceability.
- Participated in continuous improvement initiatives, leveraging lean manufacturing principles to streamline cleaning and sterilization workflows, reduce downtime, and achieve cost savings.
Validation Engineer
Jan 2022 - Sep 2023
Verista (acquired Delta Project Management in Jul 2022)
- Executed protocols to perform revalidation of Controlled Temperature Environments, including freezers, incubators, cold rooms, and warehouses.
- Conducted investigations to determine root causes of excursions observed during testing.
- Identified system nonconformities to specifications and offered recommendations for solving deviations.
- Summarized study results analyzed in Microsoft Excel through formal reports to clientele.
- Balanced several deliverables and managed timelines for each individual project to meet client needs and deadlines.
- Facilitated training of new team members and provided guidance to ensure adherence to industry guidelines.
Microbiology & Molecular Genetics Student Assistant
Sep 2017 - Jun 2021
University of California, Davis
- Prepared for the upcoming quarter's courses within the academic department by keeping track of 40+ instructors and teaching assistants.
- Oversaw the department's website by updating and creating content.
College of Biological Sciences Dean's Office Student Assistant
Mar 2020 - Jun 2021
University of California, Davis
- Created the study abroad webpage and subpages for the College of Biological Sciences.
- Periodically updated the site with course offering information.
Mechanical Engineering Intern
Jun 2019 - Sep 2019
Nelson & Associates - IDEX Health & Science
- Conducted Highly Accelerated Life Testing (HALT) on valves used in High Performance Liquid Chromatography (HPLC) applications to test the reliability of rotor seal components.
- Executed a Design of Experiments (DOE) to find causes of difference in the stator lapping and polishing processes at the Rohnert Park IDEX site.
- Investigated an issue with a sticking phenomenon observed in valves used in biological sample applications. Tested the specific hypothesis that introducing Bovine Serum Albumin (BSA) would cause sticking on internal valve components, indicated through high torque readings.
- Collected and analyzed test data with Microsoft Excel to report findings and make recommendations through formal written test reports.
- Designed a tool in SolidWorks to be used in the Engineering Lab for easier torqueing of the MarvelXact fitting. Revised and refined design through multiple iterations, with feedback received from each 3D printed prototype.
