SUMMARY:

• Over 17 years combined experience in FDA regulated medical field supporting Non Profit Start - Up’s, Pilot Process Plants, and Commercial Manufacturing.
• Supported equipment and process designs, international knowledge transfer, Design of Experiments, gage repeatability and reliability studies, IQ/OQ’s, Engineering Test Methods, and Engineering Test Protocols.
• Recent experience supporting Cardio Stent Startup, Low Cost HIV detection device, an aortic AAA stent graft system, coronary guide catheter’s, angioplasty balloon catheters, and vascular closure device’s including development and design processes.

TECHNICAL SKILLS:

Microsoft Based Software applications: Word / Excel / PowerPoint / Visio / Office Project

Calibration and Maintenance Management: Pilgrim / Calman / Maximo

Software based training systems: Enable / gLearn / Kaplan Engineering

Materials and Procurement Management: Empac / Ariba / JDE

Document Control: gMMS / Core / Cpdm

Software Automation: RS Logix / Wonderware / Honeywell

Data Processing: SAP

PROFESSIONAL EXPERIENCE:

Confidential, Foster City, Ca

Maintenance Manager & Team Lead

• Supporting in the design, installation, modifications, and maintenance of pilot - plant and laboratory equipment.
• Working on start-up activities for new equipment (installation qualification).
• Performing custom fabrication of process devices, parts, accessories and equipment with various types of materials of construction.
• Locating and diagnosing mechanical, electrical and plumbing failures associated with pilot-plant and laboratory equipment, replacing defective components and performing basic troubleshooting using standard electronic equipment, detailed drawings, diagrams, sketches, specifications, prints, manuals and verbal and/or written instructions.
• Preparing required engineering and manufacturing documentation. Performing activities to support pilot plant operations. Procuring spare parts, labor, special tools, contracts, documentation and equipment availability for Preventative Maintenance.
• Executing PM s as coordinated with Maximo. Source, schedule, assist and monitor the work of contract service providers for repairs and services in the pilot plant.
• Maintaining appropriate pilot-plant equipment maintenance and repair logs.
• Compiling with all safety and cGMP regulations.
• Responding to emergency notifications via phone and performing required emergency repairs.

Principal Technician Facilities & Equipment Maintenance

• Coordinating and assisting in site facilities repairs, including building utilities and facilities equipment.
• Performing Preventative and Corrective repairs on equipment in R&D labs and CER environments.
• Performing equipment calibration activities on manufacturing equipment.
• Implementing and maintaining equipment and spare parts inventory.
• Designing and modifying machine parts and fixtures through the use of machine shop equipment, (Lathe, Mill, and Presses).
• Installing and qualifying Manufacturing and R&D equipment.
• Shipping & Receiving of Equipment, Product, and Materials.

Facility, Equipment, Calibration Technician/Coordinator

• Maintaining and repairing site facilities, including utilities and facilities equipment.
• Performing regular, routine PM on Facility and Manufacturing equipment including work in CER.
• Coordinating equipment and facilities maintenance and calibration activities.
• Maintaining and updating calibration database and scheduling calibration work through vendors.
• Implementing and maintaining equipment spare parts inventory.
• Performing routine troubleshooting and repairs to Manufacturing equipment.
• Monitoring and maintaining EHS inventory and supplies.

QA Principal Technician

• Conducting technical quality assurance inspections and tests, documenting results and performing investigations
• Completing record of inspection results, acceptance, rejection and disposition
• Performing complex tests and analyses to assure that products comply with established specifications
• Conducting scheduled calibration and maintenance on test equipment
• Coordinating specialized product/customer quality testing and prepares reports on results
• Troubleshooting defective products to determine root causes of failure and compiles data to identify trends and proposes corrective action’s

R&D Principal Technician

• Supporting engineering in process characterization of hydrophilic coating
• Designing tooling and fixtures for a catheter dip coating and drying systems
• Developing process standards for a lubricious coating, drying and cleaning process
• Assisting in the design and development of hydrophilic coating, drying and wash station equipment
• Designing and executing Engineering test protocols
• Supporting R&D activities in the test method validation of new products

Principal T echnician

Responsibilities:

• Applied non-standard electrical, mechanical, electromechanical, optical, and test duties in such areas as manufacturing, maintenance, quality, testing and engineering
• Constructed, inspected, calibrated, adjusted, tested, documented, and maintained equipment, components, devices and systems
• Assisted in the process of releasing validated equipment and processes to production, including documentation releases, production personnel training and production problem troubleshooting
• Directly involved in the design, prototyping, and pilot testing of new products, processes, test methods and procedures

Sr. Maintenance Mechanic

• Performed repairs, fault diagnostics and troubleshooting of industrial electrical systems and equipment
• Completed tasks and work orders with appropriate documentation according to standard operating procedures, applicable standards, guidelines, practices, and policies
• Utilized ability to read and understand Electrical Drawings & P&ID's for support of field installed equipment
• Prepared and organized technical documentation, operational procedures, and preventive maintenance procedures for industrial electrical systems and equipment
• Coordinated contractors performing repairs, modifications, and installation of electrical equipment
• Inspected new installations and modifications by contractors and executed the necessary changes to comply with industry and company standards

Senior Process Maintenance Technician / Mechanic

• Worked in a GMP environment, wrote maintenance procedures for equipment and utility systems as well as performed their preventive and corrective maintenance.
• Supported engineering, calibration, and R&D through project improvements and equipment repairs (electrical, pneumatic, and hydraulic systems)

Residential / Commercial wireman Foreman

Responsibilities:

• Managed work on both High and Low Voltage Systems for commercial, industrial, and residential
• Facilitated on-call repair work and troubleshooting of electrical, mechanical equipment and supply power systems
• Assisted in customer support for project improvements as well as job estimating and cost analysis
• Coordinated installation as well as repair work in clean room environments