David Bellucci Email & Phone Number

Winchester, Ca, Us

Irvine, California

Establish Facility, Utility and Equipment Qualification program. Write SOPs for specifications development, qualification systems, deviations handling and related documentation requirements. Managed contract Engineers in the Qualification of Facility, Utility and Process Equipment projects. Establish metrology systems. Write SOPs related to metrology systems, instrument calibrations, contract calibrations and related documentation requirements. Manage contract calibration providers in the course of metrology work performed at Anchen. Specify and validate computer systems for control of metrology. Establish Engineering Documentation control system. Active member of Engineering review board for facility, utility and equipment specifications. Work with General Contractors and Sub-Contractors in the development of plans and specifications for new facility construction projects.

Developed and Rolled Out Validations Systems for Facility, Utilities, and Equipment.Developed and Rolled Out Metrology Systems for the calibration of 3,000 + instruments.Developed and Rolled out Computer Validation Systems.Managed: 7 Staff Engineers, as many as 7 to 12 Consultant Engineers, and 2 Administrative individuals.Managed the Validations of the following Systems: Building Management, Purified Water, Purified Air, Autoclaves, HVAC, Dust Collection and Environmental Monitoring.Managed the Validation of the following Equipment: Tablet Presses, Encapsulators, Blenders, Environmental Chambers, Mills, Chilisonators, Check Weighers, Moisture Analyzers, Soild Dose and Oral Liquid Packaging Equipment and more...Managed the qualification of the following Laboratory Instruments: HPLC, Dissolution Systems, Gas Chromography, and others.I enjoy working with all types of people. I have presented my work to the FDA many times in the course of audits.

Corona, California

Selected to be a member of Watson's computerized system assessment team. Team performed assessments and remediation of GMP computer systems, qualification reports, and related systems. The team membership requires working knowledge of 21 CFR Part 11 and general computer validation principles.I did the research and development work required to start the Watson Calibration Laboratory in conformance to ANSI / NCSL Z540C & ISO Guide 17025. I wrote primary SOPs for the Calibration Laboratory's operation. I developed the procedures and systems related to the Watson Metrology Laboratory. I rolled out the Watson Metrology Laboratory and managed its daily activities. The lab manages the calibration of over 3000 instruments. The Watson Metrology Laboratory has passed audit by FDA and other regulatory agencies numerous times. I managed 3 Calibration Technicians.

I supervised three Quality Control Inspectors and one Receiving Inspector. Specified dimensional instruments required for the receiving inspection and first article inspection of sheet metal and plastic parts. Developed process cycles for the Ethylene Oxide and Gamma Sterilization of Surgical Medical Devices and Gowns. I specified plastic materials that could stand up to Gamma Sterilization. I developed validation protocols for the two sterilization methods. I executed the validation protocols in conjunction with contract laboratory and sterilizer services. Wrote and obtained approval for Final Reports for Sterilization Validations. Approved and Maintained Sterile and Non-Sterile production batch records. Wrote company SOPs for Quality Control and Manufacturing Operations. I drafted the company shipper carton labels with the aid of label design software. Issued Engineering Change Controls and proper submission documents required to approve over 150 Shipper Carton labels. Initiated and managed the company's automated shipper carton label system. Initiated and managed the company's customer complaint system. Initiated and managed the company's calibration system.

Tested tactical jet radar units and modules in a custom test station designed to simulate the aircraft. Trouble shot the modules to component level. Made component installation selections based on electronic performance of the units under test. Trouble shot the test station Basic software test programs in order to debug new versions. Maintained module and unit production records to conform to Air Force and Department of Defense requirements. I ensured that production hardware met Air Force and Department of Defense acceptance requirements. I analyzed electronic schematics, electrical, and mechanical drawings to ensure conformance to specifications. Followed custom software test scripts requiring the use of a variety of computer interfaced microwave and radio frequency test instruments. I used environmental test chambers to test modules and units in simulated airborne conditions.

Bs, Industrial Engineering

Associate Of Science, Electronics Engineering Technology