Hung Minh Le
Sr. Reagent Manufacturing Technician
32218 Teri Ct.
Union City, CA 94587
,CA
Summary
To seek opportunity for growth in an organization where I can grow professionally and further enhance my skills, knowledge and experience within my career.
Overview
5
5
years of post-secondary education
14
14
years of professional experience
Work History
Sr. Reagent Manufacturing Technician
Pacific Biosciences
02.2023 - Current
- Perform assigned duties according to production schedule and manually fill tubes using bulk reagents and final packaging by following work instructions.
- Perform RIR (Receive incoming Report), monthly cycle count of inventory, QC tubing and kits.
- Formulate bulk reagents using aseptic techniques according to manufacturing instructions.
- Assist in Preventative Maintenance of Zebra Printers.
- Testing and updating all required Batch Records on MES.
- Participate in process improvement projects to improve efficiencies and support business needs.
- Support QC testing and release of reagent products as assigned.
- Order lab supplies and manufacturing materials as needed or directed by Manager.
- Follow all established lab procedures and using GMP.
- Support Chip Department by performing and inspecting for chips. Process includes Dry Sort Prep, Wafer Binning and Final Packaging.
- Operate production equipment (Thermal Press Sealer) and hand tools while maintaining safe cleanroom practices.
- Recorded process data, lot information, and work orders in MES.
- Prepared materials, kits, and workstations to sustain uninterrupted production flow.
- Followed GMP, ISO, and safety procedures to maintain consistent product quality.
- Collaborated with cross-functional teams to resolve build issues and improve manufacturing efficiency.
- Troubleshoot equipment issues, minimizing downtime and keeping production on track to meet deadlines.
- Increased overall productivity by training new technicians and providing ongoing support to team members.
- Help improve production efficiency by implementing standardized procedures and streamlining workflow.
Reagent Manufacturing Technician III
Pacific Biosciences - Menlo Park, CA
12.2017 - 02.2023
- Understand lab procedure by following GMP and work instruction.
- Assist and perform in setting-up and operate automated plate filling equipment using Scinomix.
- General housekeeping.
- Print and apply labels for all production work orders such as boxes, bags, plates and tubes.
- Responsible for manual filling or using automated equipment for capping, labeling tubes and kits for production order on a daily basis.
- Perform final packaging using cold tables.
- Assist in process improvement for work instruction.
- Perform Wafer Handling by using vacuum wand.
- Perform Contact Angle on chips using a microscope.
QC Micro Technician
Grifols - Emeryville, CA
11.2016 - 12.2017
- Follow SOPs and GMP
- Inspect incoming materials for production use
- Perform proper cleaning techniques for work area and equipment
- Perform daily, weekly and monthly monitoring of Air particles and Utilities.
- Assist with sample receipt as directed by supervisor
- Collect samples of Air particles and Utilities from various sites for testing purposes.
- Using Aseptic Technique when collecting samples and processing samples
- Assist in Process Validation
- Utilize GLIMS program to create worklists, print labels and data entry
- Comply with Environmental Health & Safety (EH&S) requirements
Manufacturing Instrument Tech I
Abaxis - Union City, CA
04.2016 - 10.2016
- Maintain compliance with QMS of ISO 9001:2008 and ISO 13485:2003
- Document activities using MProg, AMS and ARS programs
- Perform safely within a biohazard environment
- Perform electromechanical assembly or disassemble of instrument
- Able to read and understand the assembly drawing
- Follow GMP, general safety rules and SOPs
- Set-up, operate and monitor production equipments until run is complete
- Package instruments for shipping
- Update software from the instrument to the latest version
- Able to troubleshoot instrument if errors present
QC Inspector
Pacific Die Cut Industries - Hayward, CA
02.2015 - 12.2015
- Comply with QMS of ISO 9001:2008 and ISO 13485:2003
- Understanding of sampling plan using ANSI/ASQ Z1.4-2008
- Assist in internal auditing
- Perform incoming and receiving inspection of raw materials with accuracy and verifying documents
- Perform in-process inspection to ensure products meet quality specifications and record onto PPM spreadsheet
- Create "Certificate of Compliance" as required
- Understanding of customer drawing
- Perform First Article Inspection Report (FAIR) using MicroVU instrument
- Create DMR for MRB and assist in CAR if there is any nonconformance within the production
- Perform in-house calibration tools by using gauge blocks for calipers and cleaning of any debris
Product Builder I
Penumbra - Alameda, CA
02.2014 - 03.2015
- Comply with Federal QSR of ISO 13485
- Assemble catheter in clean room environment
- Record the lot history records
- Follow work instructions, SOPs and safety policies
- Perform in-process inspection using microscope, caliper, snap gauge and ruler
- Set-up and operate manufacturing equipment
- Maintain housekeeping practices
- Package and label for shipment according to work instructions
Reagent Production Technician
IntegenX - Pleasanton, CA
08.2012 - 05.2013
- Clean work area before starting the production by using 70% IPA spray bottles and wipes
- Operate automated dispensing pipette or manual pipette in clean room environment
- Perform packaging and labeling according to work instruction
- Using Expandable Software program for tracking work orders and making transaction
- Support QC if needed
- Provide new input on SOPs
- Prepare buffers for production using work instruction
Education
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Fresno State, Athletic Training
09.2007 - 05.2012
Skills
Bilingual (English and Vietnamese)
Timeline
Sr. Reagent Manufacturing Technician
Pacific Biosciences
02.2023 - Current
Reagent Manufacturing Technician III
Pacific Biosciences - Menlo Park, CA
12.2017 - 02.2023
QC Micro Technician
Grifols - Emeryville, CA
11.2016 - 12.2017
Manufacturing Instrument Tech I
Abaxis - Union City, CA
04.2016 - 10.2016
QC Inspector
Pacific Die Cut Industries - Hayward, CA
02.2015 - 12.2015
Product Builder I
Penumbra - Alameda, CA
02.2014 - 03.2015
Reagent Production Technician
IntegenX - Pleasanton, CA
08.2012 - 05.2013
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Fresno State, Athletic Training
09.2007 - 05.2012