- International Society for Measurement and Control (ISA)
- International Society for Pharmaceutical Engineering (ISPE)
Wyeth BioTech, Sanford, North Carolina
Wyeth Vaccines in Sanford, North Carolina has experienced tremendous growth over the last 10 to 15 years. The facility systems are modularized in order to expedite the fabrication and to provide for enhanced Factory Acceptance Testing speeding validation activities that are conducted on site. As a result, there are many equipment and system skids that are using different manufacturers for the same application. This causes a problem with the stocking of spare parts and maintaining a “like-for-like” replacement program. Wyeth recognized the need to develop and deploy an instrumentation standardization system.
Performed an assessment and set standards for the facilities instrumentation and control systems. The facility has approximately 10,000 instruments.
The utilization of the assessment would itemize each area’s instrumentation count as well as the specifics of the devices. The information was then entered into the company SAP system for future applications reference or parts procurement. The utilization of the device standardization project was to limit vendors and expedite engineering device specifications for existing and future projects.
Bayer Bio-pharmaceutics (now Talecris), Clayton, North Carolina
Managed and negotiated contracts as a working Site Manager for a team of as many as fifteen employees to install, start up, IO check, calibrate, and assist in validation of four Calumatic prototype sterile liquid filling lines. Included were the rinser/ washers, sterilizing tunnels, fillers, stopper delivery and stopper systems, over sealers and ASE built cage loader systems. Also included two Gettinge pure steam generators, three Allpax pasteurizes with automatic loader / unloaded systems, three Serial Lyophilizers, Revco Freezers, AWFI, HWFI, cooling tower and glycol systems, MetOne particulate monitoring system, fifty two associated Allen Bradley PLC 5 operating systems. Andover HVAC Environmental Control system and low and medium voltage Allen Bradley switch gear.
Development assistance of instrumentation standard calibration procedures for above listed facility and process systems. Class 100-room gown certified.
GlaxoSmithKline, Zebulon, North Carolina
Managed staff for instrumentation installation of a new Bailey InFi90 DCS systems for complete facility control. The system installation effort included a hot changeover of an existing commercial HVAC control system to a new qualified Distributed Control System. The changeover included over 50 air handling systems and 1500 instruments in an operating facility.
Organized and managed changeover preplanning activities for weekend shutdowns and systems start up and commissioning.
Colonial Carton Company, Clayton, North Carolina
Developed a facility Validation Master Plan to direct the Colonial Carton QA team. Managed the qualification effort for various carton manufacturing efforts that included printers, folders, die cutting and proofing machines. Efforts include writing and executing validation protocols as well as establishment of a QA/QC program for this vendor to the pharmaceutical industry.
Ethicon Endo-Surgery, Cincinnati, Ohio
Performed the GMP calibration for 8 anesthesia machines and 5 EKG machines in preparation for validation activities that would bring the equipment to a clinical trial applicable level.
Site Services, various locations
Biogen IDEC, Research Triangle Park, North Carolina
Merix Bioscience, Durham, North Carolina
Covance Pharmaceuticals, Research Triangle Park, North Carolina
Apex Bioscience, Research Triangle Park, North Carolina
Élan Pharmaceuticals, Gainesville, Georgia
Imed Laboratories, Glen Allen, Virginia