Bruce Reynolds Email and Phone Number

-Supervise Packaging Engineers -Core team member for new product development projects-Lead for Continuous Improvement projects

 Packaging Engineer lead for Mechanical Instruments and Suture products.  Procure and validate sealing and printing equipment for both flexible and rigid packaging systems, FAT, DOE, IQ, OQ and PQ. Validation of test methods for package integrity testing to meet ASTM standards.

 Provide daily Engineering support in the packaging of absorbable and non absorbable sutures. Team member for new production equipment installations in North Haven, packaging and non packaging related. Project leader for equipment improvements within North Haven, write and execute protocols for qualification. Core team leader for the Polysorb Injection port project

 Coordinate all Engineering activities in Solid Dose area. Provide daily direction to union mechanics, electricians, and other staff in support of manufacturing relative to granulation, tableting, coating, and filling equipment, and general facilities maintenance. Provide Engineering support for large scale projects, FAT, SAT, Commissioning and Validation efforts for Facility and Production equipment. Support all building design and construction efforts taking into consideration, room layouts, utility requirements, cleaning and operating capabilities for Manufacturing. Responsible for review and approval of record drawings of manufacturing area. Develop preventative maintenance programs for facility and production equipment. Ensure area compliance with all regulatory requirements mandated by FDA (cGMP) for pharmaceutical manufacturing, SOP review and changes.

 Responsible for automated form, fill, and seal equipment used to package absorbable and non absorbable sutures. Write specifications for new equipment, perform FAT, SAT, and commissioning. Coordinated and execute Validation for packaging equipment, including writing and execution of equipment and performance qualification protocols, IO/OQ/PQ. Designed and implemented process and equipment modifications, update SOP’s, training of operators and maintenance staff.