Experience

CTK Biotech, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Validation Engineer

  • Jun 2021 - Present

  • Managed on-site validation activities, supporting quality assurance and manufacturing, for an in-vitro diagnostics chemical reagent manufacturer. Authored validation protocols, coordinated execution, created/edited relevant SOPS/WIs, assembled ancillary documentation (training/calibration/batch records, manuals, specifications, supporting literature, et al,) and authored final reports. Researched methods/standards and performed studies to determine performance/acceptance criteria. Tracked validation activities with Validation Log and Master Equipment List/Master Validation Plan, and maintained validation records. Assisted QA with the resolution of CAPAs. • Managed (interim) operations and facilities activities, including equipment calibration and repair, environmental monitoring, and site compliance with city/county/state regulators and/or permitting agencies (e.g. Cal-EPA, CERS, San Diego County HMD/DEHQ and the City of Poway.) Managed vendors, obtained quotes for calibration/repair or other services, and created purchase requests/orders using ERP system (SAGE.) Show less



Quidel

• United States
• Medical Device
• 400 - 500 Employee

• Project Engineer, New Product Validation

  • Apr 2018 - Mar 2019

  • Supported validation requirements for the Triage® TOX DS 94600, a novel drug screening device manufactured at QCI (San Diego, CA). Authored validation protocols (IQ, OQ and PQ/PV) and managed training of personnel on SOPs and validation documents to support validation execution. Coordinated the resolution of validation deviations by performing investigations, impact assessments and by creating action plans to resolve each deviation. Authored final reports and included the data analysis, results summary and final conclusion for each validation. Key Achievements: • Authored and implemented overall process validations (PQ/PV) supporting device assembly, assay chemistry tuning and calibrator manufacturing for the Triage® TOX DS 94600 drug screening device. Show less



Alere Inc.

• United States
• Medical Device
• 700 & Above Employee

• Project Engineer, Process Transfer and Validation

  • May 2016 - Oct 2017

  • Supported the consolidation of device manufacturing from Branan Medical Corporation to Ameditech (Alere) by leading the process validation for the assembly of two product families. Consolidation was completed within an aggressive twelve month timeline, requiring significant effort in resolving validation and equipment related issues. • Supported QA/Regulatory/Marketing, for the transition of all product SKUs to meet FDA labelling requirements for Unique Device Identification (UDI,) allowing the sell product after the mandated time frame (September 2016). Key Achievements: • Authored protocols and managed ancillary activities for the transfer and validation of assembly processes and equipment. Converted product labeling for all finished goods to meet the FDA’s mandated UDI requirements. Show less



Halliburton

• United States
• Oil and Gas
• 700 & Above Employee

• Lead Field Engineer-LWD/MWD

  • Jan 2012 - Jun 2013

  • Lead Measurement While Drilling (MWD) activities, supporting the directional drilling of oil wells. Specified, assembled, tested and installed logging equipment. Supervised and trained field engineers. Managed inventory, including sensors, drill collars, and ancillary equipment. Collected and analyzed real-time data, allowing for drilling adjustments. Prepared reports and well-logs for site manager, geologist and state government agencies. Key Achievements: • Conducted root-cause analysis for tool failures, resulting in the improvement of field tool assembly processes. Show less



Beckman Coulter Diagnostics

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Technical Operations Engineer

  • Jan 2007 - Nov 2010

  Directed projects to identify and implement improvements to processes, plant equipment, and facilities in support of Company strategic objectives to enhance manufacturing. Scoped, designed, and conducted experiments to ascertain process capability and overall equipment effectiveness (OEE), and used the results to recommend process changes and upgrades to manufacturing equipment. Compiled user requirement specifications (URS), request for quotes (RFQ), and justifications for equipment procurement, and identified, evaluated, and selected vendors for capital improvement projects. Provided engineering support for lean manufacturing and six sigma initiatives. Key Achievements: • Supported quality assurance and validation functions by serving as the Subject Matter Expert on the performance of FMEAs, CAPAs and by developing, reviewing, and implementing Installation, Operational, and Process Qualifications (IQ/OQ/PQ). Show less



Toppan Group

• Printing Services
• 400 - 500 Employee

• Lead Process Engineer

  • Mar 2005 - Jan 2007

  Enhanced processes in the manufacture of acrylic resin molded rear projection television screens (FC Screens), and trained and managed the Process Technicians supporting the manufacturing processes. Supported all automated process equipment, which included resin coating, screen molding, lamination, and UV activated resin curing, and laser cutting (Mitsubishi laser system), performed troubleshooting of mechanical or material-related process issues, and provided 24-hour process support. Developed procedures and trained Production staff in the latest techniques for machine operations and process troubleshooting. Visited the sites of customers such as Sony, JVC, Samsung, and Baja California for the purpose of resolving process and quality-related issues. Key Achievements: • Conducted experiments, analyzed data, and implemented initiatives to boost process yield, output, and overall product quality from each process unit. • Served as a Subject Matter Expert on process quality issues ranging from supplier quality to end user quality and thus supported Quality Assurance. • Formulated plans for the transfer of the die assembly process from Toppan, Japan to Toppan, Poway, prepared the necessary documentation, compiled written progress and status reports, and prepared data analyses for weekly presentations to Management and peer Engineers. Show less



Lam Research

• United States
• Semiconductor Manufacturing
• 700 & Above Employee

• Process Engineer

  • 2000 - 2002

  Designed, optimized, and implemented processes run on plasma etch reactors, with the purpose of selectively removing thin dielectric films from wafer substrates, for the production of microchips. Designed, optimized, and implemented processes run on plasma etch reactors, with the purpose of selectively removing thin dielectric films from wafer substrates, for the production of microchips.