Consultant, Kevin Kennedy Associates Inc.
Providing expertise in computer systems validation, process control system qualification, mechanical and computer systems for manufacturing and packaging equipment, utilities and processes, and related expertise to a wide variety of clients.
Project Leader 2, Bristol Myers Squibb, Manati, Puerto Rico
Process Automation System (PAS) Qualification Project Developed and executed IQ/OQ for the Process Automation System (PAS) serving the Formulation, Filling, CIP/SIP and Quality Utilities (QUMS) Areas in the Manati Sterile Expansion Project. Was responsible for designing and writing the Control Modules (CM) and Equipment Phases (EP) testing. Coordinated the schedule and validation activities. Prepared Validation Reports and Deviation Reports as necessary. Conducted investigations for the generated incidents that includes troubleshoot.
PR5 Delta V Upgrade Project, Lilly del Caribe, Carolina, Puerto Rico
Developed Test Cases for the Fermentation and Utilities Areas screens being changed as part of the PR5 Delta V Upgrade Project. Prepared a Project Plan for the testing activities required as part of the PR5 Delta V Fermentation/Utilities Areas screens upgrade project.
Senior CSV Specialist, Tyco Healthcare (Medical Device Industry), Juarez City, Mexico
CSV Remediation Project during a FDA consent decree. Performed and executed computer validation protocol. Coordinated the schedule and validation activities.
Process Control System (PCS) Qualification Project, Start-up of the Epogen Facility (Biotechnology Industries), Amgen, Juncos, Puerto Rico
Coordinated validation activities with the validation specialist, System Owners and Manufacturing Supervisors. Developed and/or executed CSV Installations and Operational Qualification Protocols for the PCS Control Panels (PLCs), Bioreactors, Tanks, Filtration Skid and Chromatography Columns in Media Preparation, Cell Culture, Harvest and Purification Areas.
Automation Qualification Project, Start-up Project in the Neupogen Facility (Biotechnology Industries)
Coordinated validation activities with the validation specialist, System Owners and Manufacturing Supervisors. Executed and reviewed CSV Installations and Operational Qualification Protocols for the Clean in Place Systems, Bioreactors, Tanks, Filtration Skid and Chromatography Columns in Media Preparation, Cell Culture, Harvest and Purification Areas. As part of Performance Qualification protocol, performed sterilization studies (SIP) using the Kaye Validator 2000. Prepared final validation reports using the gathered data during the protocol execution.
Senior CSV Specialist, GlaxoSmithKline, Cidra, Puerto Rico
Commissioning/Qualification Remediation Project during the FDA consent decree. Developed and executed Mechanical and/or CSV Installation and Operational Qualification protocols for Coater Machines, Solution Preparation Systems, Wash in Place System and Drum Lifter Inverters. Prepared exceptional condition reports and summary reports as necessary. Executed Commissioning Protocols (IV and OV) for HVAC system.
Commissioning / Qualification Project, Bulk Humira® Facilities, Abbott, Barceloneta, P.R.
Developed and executed Commissioning and IQ/OQ/PQ protocols for Clean in Place Systems, portable tanks, buffer holding tanks and buffer prep tanks at a new biotechnology manufacturing facility (Humira Project). Prepared Validation Reports and Exceptional Condition Reports as necessary. Conducted investigations for the generated incidents.
Senior Validation Specialist, Schering Plough LLC, Manatí, P.R.
Hands on experience leading computer systems validation processes in a FDA related environment. Remediative Action Project for the site EDMS (Documentum). Part 11 Gap Analysis Project. LAN Upgrade Project - Preparation, coordination and execution of IQ/OQ for network component as switches, routers, servers, KVM, UPS, LAN drops, and Fiber Optic runs. MP2 Qualification Project - Preparation and execution of SAT and Validation Protocols (IQ, OQ, and PQ). WFI System Qualification Project - Development of documentation (Validation Plan, URS, FRS, DS and RTM) required by the SDLC approach. Preparation, coordination and execution of IQ, and OQ protocols.
