Raye Field

Raye Field has been providing engineering and validation services in the medical and pharmaceutical industries since 1984. From 2001 to 2002, Raye worked as a Validation Consultant at Abbott Laboratories, where they authored Software Design Documentation and redlined existing pneumatic and electrical drawings for several packaging lines and Line 2 pregnancy diagnostic wrapper line and automation in Building K, Waukegan IL. Additionally, they performed medical device validation documentation and testing of diagnostic pregnancy test kits, biliary and vascular stents. From 2002 to 2006, Raye was a Validation Consultant at Pfizer Portage Michigan, where they completed and played a lead role in the remediation activities for the Pfizer PACT process for all 97 legacy Siemens TI plc control systems within the API plant. This included authoring of remediation documentation consisting of User Requirements and Specification Documents, Traceability Documents, Gap Analysis, Gap Matrix, 21CFR Part 11Gap Analysis, IQ/OQ/PQ and the Final Validation Report. They also executed the IQ/OQ/PQ tests with Pfizer personnel for the remediation activities, as well as completed the Allen Bradley SLC500 plc and source code remediation for site wide Fermentor, Seeding centers, and agitator controls systems. From 2006 to 2009, Raye worked as a Consultant Engineering of CIP Systems at PDL Biopharma, where they were a CIP validation engineer responsible for Val Plan, IQ,OQ,PQ, Deviations, Test Matrices, Final Summary Report of Clean In Place systems. From 2009 to 2010, Raye was a Validation Consultant at GSK Biologics Hamilton Montana, where they were assigned to commissioning and validation of legacy bio tech equipment and freezer equipment in existing Building 5 MPL® adjuvant production facility using GAMP methodologies. Additionally, they were assigned to complete the IQOQ scripts and Final Report for Building 12 lyophilizer and Gravimetric Filling System for MPL®, HPLC, chromatography and GLP assignments. From 2010 to 2011, Raye worked as a GAMP 5 Automation and Validation Consultant at Medtronics Spinal and Biologics, where they provided software validation of plant wide Indysoft Gage Insite Calibration control database MES system. They also provided engineering and software validation service for RODI retrofit, consulting engineering for multistation vision inspection system, and validations for multistation assembly systems, and RODI water equipment and CSV. From 2011 to 2011, Raye was a Consultant/Engineer at GlaxoSmithKline Toronto Canada and an Engineering Consultant for Equipment and Compliance at Xoran Technologies in Ann Arbor Michigan, solving device and electronic controls quality and compliance issues for unique computer tomography (CT) products. Quality System analysis, Gap analysis, VMP, and risk assessment supported the effort to provide the proper SDLC validation documents in order to move the product to the marketing stage, as well as solving device issues for both electrical and PEMS software.

Raye Field attended Ryerson University from 1985 to 1987, where they earned a BSc.EE in Electrical Engineering. Raye also attended Fanshawe College, though the duration of their attendance is unknown.