PROFESSIONAL SUMMARY:

Over 20 years technical experience with the Biotechnology, Diagnostic, Medical Products, and Pharmaceutical Corporations. Very knowledgeable with the calibration of pharmaceutical and manufacturing process equipment, and with using HART protocols. Exceptional mechanical aptitude utilized to support Engineering, R&D and Manufacturing operations.

SUMMARY OF SKILLS:

• Microsoft Office
• Blue Mountain (Calman)
• Procal
• Project Management
• cGMP/ISO 9001
• Clean Room Operations
• FDA
• Basic Microbiologyg
• Code of Federal Regulations - 21 CFR Part 11
• Validation Requirements & Practices
• Palltronic & Millipore Filter Integrity Testing

EXPERIENCE:

Electro-Mechanical Instrumentation

Confidential - Broomall, PA

Responsibilities:

• Perform high pressure transducers calibrations on gas mixing stations.
• Perform parameter captures on all pressure and temperature controllers.
• Perform preventative maintenance on vacuum pumps and repairs as needed.
• Work with Electrical Engineering on special projects assigned by Plant Manager to be completed by end the quarter.
• Clean manifold and rebuild gas mixing valves.
• Enter finished work orders into CMMS database (Maximo).

Maintenance Mechanic

Confidential - Wayne, PA

• Repair of packaging line equipment (syringe filling).
• Work with Engineering to resolve complex problems utilizing a high speed resolution camera and make necessary adjustments or repairs

Senior Calibration Technician

Confidential - Morris Plains, NJ

• Repair and calibration of process, lab equipment, utilities and facilities, related to manufacturing process but not limited to, autoclaves, incubators, Rosemont transmitters, pressure transmitters and Honeywell recorders.
• Loop and electronic calibrations performed.
• Assure that all standards used are in compliance.
• Arrange with R&D personnel prior to any work being performed, utilizing Procal Database.

Maintenance Mechanic

Confidential - New Brunswick, NJ

• Perform and execute unscheduled repairs and preventative maintenance for all process equipment, utilities equipment, facilities equipment, and air handling units.
• Assist external contractors to complete their PM for respective systems/equipment.

Calibration Specialist

Confidential - Ft Washington, PA

McNeil CPC

• Establish a calibration program by reviewing all newly installed instruments and verify information such as; serial numbers, manufacturer’s information and input this data into the database.
• Establish operations tolerances by using manufacturing data instrument tolerances.
• Work with Process Engineering to establish process tolerances.

Instrumentation Technician

Confidential - Branchburg, NJ

• Repair and calibration of process, lab equipment and utilities related to manufacturing process but not limited to; autoclaves, incubators, Rosemount transmitters, pressure transmitters and Honeywell recorders.
• Loop and electronic calibrations performed.
• Assure that all standards used are in compliance.
• Arrange with contractors, Quality, Production, Facilities, Utilities, and Engineering/R&D personnel prior to any work being performed.

Engineering Technician

Confidential - Philadelphia, PA

• Inspected facility related manufacturing support systems on a daily basis.
• Set-up, adjust, repair, and maintain all compression and coating equipment in accordance with diagrams, sketches, operation manuals, and manufacturer’s specifications, machinery and mechanical equipment, such as engines, motors, pneumatic tools, conveyor systems, and production machines and equipment, using hand tools, power tools, and precision measuring and testing instruments.

Consultant - Senior Calibration Technician

Confidential - Lansdale, PA

• Repair and calibration of process, lab equipment and utilities related to manufacturing process such as; autoclaves, incubators, Rosemount transmitters, pressure transmitters and Honeywell recorders.
• Loop and electronic calibrations performed.
• Assure that all standards used are in compliance.
• Arrange with contractors, Quality, Production, Facilities, Utilities, and Engineering/R&D personnel prior to any work being performed.
• Calibration data template design utilizing the Blue Mountain Data Base and Historical Calibration Documentation. Along with instrumentation specification sheets.
• Extend calibration intervals by reviewing prior calibration records and initiating change controls.
• Responsible for the calibration of manufacturing, and R&D equipment, calibration and maintenance of waste water system within the facility service department.

Project Specialist

Confidential - Lawrenceville, NJ

• Work with engineering on the purchase of new equipment.
• Evaluate processing equipment to be installed before and after purchase.
• Work with engineering on installation of equipment according to IQ validation protocol.
• Perform OQ validation and adjust according to the company’s needs for processing.
• Train operators on the safety and procedure of new equipment and process qualification.

Consultant - Maximo Consultant Specialist

Confidential - New Brunswick, NJ

• Verification and determination of data and engineering specifications according to P&ID for all the mechanical and manufacturing equipment in the pilot plant and research areas.
• Collecting technical data in the field and extracting data from vendor documentation to provide equipment data input for the Computer Management and Maintenance System (Maximo Software) database according to FDA, and cGMP.

Consultant - Validation Specialist

Confidential - Chicago, IL

• Responsible for the validation of process, facilities and equipment.

Instrument Engineer

Confidential - Spring Valley, NY

• Responsible for the calibration of manufacturing equipment, R&D, Quality Assurance and Quality Control.
• Assist in-house engineer with validation studies on manufacturing equipment.
• Assist maintenance department when needed, with mechanical troubleshooting and repairs.
• Update calibration SOP’s.

Consultant - Validation Technician

Confidential - Edison, NJ

• Assist in Validation Department with review and updating validation protocols.
• Perform validation IQ, OQ, PQ, cleaning, computer, and process validation within granulation, coating and LOC departments.
• Worked with operators in performing W.F.I. validation transfer from department to department and in taking samples over 36 hours.
• Perform as well as supervise operation personnel.
• Worked on summary reports and closeout.
• Review with department supervisor SOP’s and update as needed.

Consultant

Confidential – New Brunswick, NJ

• Verification and determination of data and engineering specifications for all the mechanical equipment on site, located in manufacturing, pilot plant, research areas, and in office buildings.
• Collecting technical data in the field and extracting data from vendor documentation to provide equipment data input for the Computer Management and Maintenance System (Maximo Software) database according to FDA, and cGMP.
• Make necessary adjustments and repairs to minimize downtime.
• Perform all duties as described in the Preventive Maintenance Program.
• Follow instructions and prints from Manager, group leaders, or engineers to maintain repair, install, or alter production equipment.
• Operate production equipment after PMs, repairs, and adjustments to ensure machine is operational.