Huntington Beach, CA 92646
SUMMARY OF SKILLS: Detail-oriented professional engineer with strong technical/metrological background. Experience in troubleshooting circuits/electrical components, interpreting mechanical drawings/schematics, calibrating/repairing testing equipment, and project management. Certified in PLC 5, Control Instrumentation, Calibration in the FDA Regulated Industry, OSHA, Metrology Principals.
Gilead Sciences Inc., San Dimas, CA ( Sterile Injectables Rx)
Senior Maintenance Technician/Acting Lead (Metrology) 2007 - Present
Work on assignment that is complex in nature where independent considerable judgments and a high degree of initiative are required in resolving problems and making recommendations.
Lead and provide oversight daily Metrology Operation including hands-on calibration, repair and provide technical supports for numerous types of equipment and test devices used throughout the Biotech Pharmaceuticals Company.
Write, review and approve CAPAs and QA Investigation Reports, Standard Operation Procedures (SOPs) and formal reports.
Resolve quality (Out of Tolerance) and reliability issues related to Metrology CALPM Instrumentations and HEPA Testing and Certifications.
Administrator for the Maximo/GMax ECMMS. Provide training and customer supports for all users. Create infrastructure for Metrology instrumentation. Implement CMMS Migration to completion. Execute Validation IQ/OQ/PQ scripts per approved protocol. Generate, review and approve work orders.
Work on numerous types of special projects as assigned by the department director/manager.
Administrator for the HEPA Program. Direct all activities for Cleanroom HEPA Filters and Hoods/Ovens Testing and Certification Projects. Review and approve all Certification Reports.
Provide technical training, qualifying and ensuring that all staffs adhere to safety protocols and cGMP requirements to comply with FDA and ISO standards. (Qualified Trainer)
Manage SOPs and systems related to Calibration and HEPA Certification and support the group with efficiently improvement efforts.
Edwards Lifesciences, Irvine, CA
Senior Technologist (QA Metrology) 2003 - 2007
Provide hands-on calibration, repair and technical supports for numerous types of test electronic, physical dimensional, and facility instruments and test devices used throughout the plant facilities.
Develop calibration test methods, SOPs, and reports.
Resolve quality (Out of Tolerance) and reliability issues related to instruments.
Planning and interacting with all levels of production, maintenance, and laboratory management to perform calibration services so as not to impede the production process.
Assist the organization in interpreting and selecting measurement and calibration options that provide required accuracy.
Manage SOPs and systems related to calibration, and support the Metrology group with efficiently improvement efforts.
Provide technical training and ensuring that all staffs adhere to safety protocols and cGMP requirements to comply with FDA, ISO 17025 and ANSI Z540 standards.
TevaPharmaceuticals Inc., Irvine, CA (former GensiaSicor) (Sterile Injectables Rx)
Senior Metrologist III 1999 - 2003
Responsible for calibrate, troubleshoot, repair, and provide technical supports for numerous types of equipment and test devices used throughout the plan facilities.
Conduct internal audits of Metrology documentation.
Develop calibration procedures, SOPs, and reports.
Schedule and coordinate equipment calibration projects with other department managers and outside vendors.
Provide technical training and ensuring that all staffs adhere to safety protocols and GMP requirements to comply with FDA and ISO standards.
Responsible for directing all activities for cleanroom HEPA Filters Certification projects.
CALIFORNIA STATE UNIVERSITY OF LONG BEACH
B.S. degree in Electrical Engineering Program
SANTA ANA COLLEGE
A.S. degree in Electronic Industrial Technology
PROFESSIONAL SKILLS AND QUALIFICATIONS
Excellent analytical and interpersonal skills, self-motivated, detail oriented and professional reliable.
Knowledge of engineering principals. Ability to interpret mechanical drawings, test specifications, SPC methodologies, and electronics schematic diagrams.
Skillful in troubleshoot electronics circuits and electrical components by using different types of test instrumentation.
Experienced in using variety of computer software such as MS office, Auto-Cad, C, Lab-view, Allen Braley PLC, SCADA, Oracle, GTrack, Blue Mountain Calman, Fluke Met/Cal, GageTrak and Maximo/GMax ECMMS.
Skillful in team project management, and coordinating staffs to effectively achieve tight deadlines.
Certified training certificates for PLC 5, Control Instrumentation, Testing HEPA Filtered Systems & Clean-Rooms, Calibration in the FDA Regulated Industry, OSHA, Hart Scientific Temperature Calibration, Met/Cal Procedure Writing, Metrology Principals, NIST seminars, NCSL/ MSC workshops, Electricity Seminar, Blue Mountain Calman, and Maximo ECMMS.
Professional references available upon request.