Consultant, Kevin Kennedy Associates Inc.
Providing expertise in facilities, utilities, process, equipment/systems, and computer system validation (CSV), qualification/validations, manufacturing and packaging, and related expertise to a wide variety of clients.
Validation Consultant, Pall Life Sciences, Filter Manufacturing Facility, Fajardo, Puerto Rico
Developed installation and operational verification reports for the Clean rooms including room utilities (Electrical, DI water, chilled water supply, chilled water return, compressed air, clean air, hose vacuum, and process vacuum). Developed engineering study and summary report for manufacturing and packaging facilities. Executed Installation and Operational Reports.
Validation Consultant, Bristol Myers Squibb, Pharmaceutical Facility, Humacao, Puerto Rico
Updated, compared and matched retrospective protocols data from 10 year ago to present with the Maximo Program, drawings and field verified the following equipment: Vessels, HEPA, Transmissions, Valves, HVAC, Motor, Instruments, General (Auto clave, Blender, Reactor, Air Handing Unit, Turbine Agitator)
Qualification Consultant, Amgen Manufacturing Limited, Biotechnology Facility, Juncos, Puerto Rico
Developed installation and operational qualification protocols (IOQ) for manufacturing equipment within the Fill and Finish plant including Computer System Validation (CSV). Developed Requirement and Design Specification documents for manufacturing equipment. Executed installation and operational protocols.
Documentation Consultant, IPR Pharmaceuticals
Prepared project close-out documentation: Equipment Data Books for Pharmaceutical Process. Collected and revised technical and vendor specifications, vendor and project drawings, submittals among others.
Documentation Consultant, Schering Plough Corporation, API and Aerosols Facility, Manati, Puerto Rico
Developed critical utilities certification statement for DI water, HVAC, Nitrogen, Negative Exhaust, Central Vacuum and Solvent System as part of the actions agreed in the Consent Decree of permanent injunction. Gathered and evaluated utilities performance data. Assessed cGMP's compliance of supporting documents. Assessed systems control status. Issued relevant utilities control statements as required. Interacted with utilities owner for the resolution of noted deviations. Developed commissioning and IOQ report for the solvents system supporting the API Manufacturing Operations. Executed Process Validation Protocols, Development Studies, Primary and Secondary Packaging Validations and Special Packaging Testing. Provided support to technical services department for the product transfer and validation of the Afrin (aerosols) presentations. Also participated on Special Study conducted to identified and isolate problems on the primary packaging area. Provided summary reports preparation for the related protocols.
