pharmaceutical, medical device validation expert consultant resume
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Resume of HNO Consultant
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  • Chemical
  • Manufacturing
  • Medical Devices
  • Pharmaceutical

This expert has a B.S. in Chemical Engineering from the University of Puerto Rico.

Pharmaceutical, Medical Device Validation Expert Consultant Resume

This associate is an expert in validation for solid dosage manufacturing, chemical plant, and medical devices.

Further areas of expertise include equipment and computer validation, utilities and facilities qualifications, commissioning and qualification of manufacturing, and packaging areas in solid dose manufacturing.

As a validation scientist and validation engineer, this consultant has extensive experience in areas related to and including process equipment such as holding tanks, mixers, fluid bed dryer, and high shear granulator. Additional background experience includes bin blenders, tablet press machines, and coating machines. This includes development and execution of equipment requirements, functional specifications, equipment vendor testing, and standard operating procedures for cGMP applications. This consultant is also experienced in FDA regulatory compliance.

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in validation for solid dosage manufacturing, chemical plant and medical devices industries, and related expertise to a wide variety of clients.

 

Validation Consultant, Schering-Plough, Las Piedras, Puerto Rico

Was assigned to perform equipment and computer validation, utilities and facilities qualifications for pharmaceutical and medical devices industries. Responsibilities included execution and review of Site Acceptance Test (Installation and Functional Verification) for a Spectrum Tablet Film Coater, Air Preparation Unit and Solution Preparation System for the Small Scale Facility project in adherence with project schedule. Developed and executed IQ/OQ/UAT (Mechanical and Computer Validation) for a Spectrum Tablet Film Coater, Air Preparation Unit and Solution Preparation System for the Small Scale Facility project. Also, generated the summary report and Requirement Traceability matrix for this equipment in adherence with project schedule. Conducted technical review of the executed OQ/UAT for Niro MP4 Fluid Bed Dryer and generation of the Requirement Traceability matrix for this equipment. Generated summary reports for Intermediate Bull Containers (IBC’S) and Intermediate Bull Containers Wash Station.

 

Commissioning & Qualification Team Leader, Glaxo SmithKline Pharmaceuticals, Cidra, Puerto Rico

Led the Commissioning and Qualification group that support the manufacturing and packaging areas in solid dose manufacturing GSK Cidra Site. Special Assignment – Dedicated to lead all commissioning and qualification activities for the New Dispending Area as part of Cidra Compliance Capital Program (CCCP) project. Was in charge of implementation of the best practice for commissioning and qualification base in the risk base approach to improve the qualification timeline schedule and reduce the validation contractor costs. The overall project cost was over 30 million, where 2.6 million was assigned to commissioning and validation activities. Supervision of two (2) GSK C&Q scientist and over eight (8) validation contractors in charge of the commissioning and qualification activities of the project. Was responsible for direct supervision of eight (8) GSK commissioning and qualification scientists and one technician in charge of the qualification activities for the equipment, facilities and utilities of the GSK Cidra Site. Managed a $750K budget for the Commissioning and Qualification Area contractors. Evaluated the Technical Change Controls and established the qualification requirements to comply with GSK SOP’s and FDA regulations. Participated in the revision and implementation of the New Standard Operating Procedures (SOP’s) for the validation area as part of GSK Cidra Consent Degree Remediation Program. Led the GSK commissioning & qualification scientist in the qualification activities and technical review of the validation binders of the new packaging lines installation and two new coating suites as part of Capital Compliance Program (CCCP) project. Met expected results with the third party auditory.

 

Validation Scientist

Was assigned to perform equipment and computer validation, utilities and facilities qualifications for solid dosage manufacturing process. Supported Process Validation area (Granulation/Compression/ Coating) and sterile area equipment re-qualification. Performed equipment and computer validation for process equipment (Holding Tanks, Mixers, Fluid Bed Dryer, High Shear Granulator, Bin blenders, Tablet Press Machines & Coating Machine). Performed utilities (HVAC’s, Compressed Air System, Purified Water Systems, Dust Collection) and facilities qualifications. Supported Process Performance Validation area (Granulation/Compression/ Coating). Performed and executed Autoclave re-certification for sterile area. Developed and executed equipment requirements, functional specifications, equipment vendor testing, and standard operating procedures for cGMP applications. Developed and managed equipment technical changes (change control documentation) to comply with FDA regulations and protected quality of product – at the same time these ease the manufacturing process. Examples include implementation of the control system for compression equipment and control system changes for coating system. Provided technical support to the manufacturing operation areas in troubleshooting equipment, SOP revisions, while guaranteeing the quality of the product.

 

Validation Engineer, Wyeth, Guayama, Puerto Rico

Developed and executed IQ/OQ (Mechanical and Computer Validation) for Coating Machine and Solution Preparation System for Protonix Expansion Project. Developed and executed IQ/OQ for Bulk Solvent and Solution Preparation System, Granulation Charging System, QA Laboratory Facility Qualification for Effexor XR expansion projects. Laboratorios Behrens, Caracas, Venezuela Designed, generated and executed IQ/OQ/PQ protocols and reports for the solution preparation tanks, bottle washer machine, filler and Sealer machine, Capper Machine and packaging line (labeler machine and printer encoder). Bristol Myers Squibb, Mayaguez, Puerto Rico Designed, generated and executed IQ/OQ/PQ protocols and reports for the validation of Manufacturing Execution system (MES). Ocular Sciences, Juana Diaz, Puerto Rico Developed and executed IQ/OQ/PQ protocols and reports for utilities (HVAC and Compressed Air) as part of the Juana Diaz Building start up. Developed and executed IQ/OQ/PQ protocols and reports of equipment (Blister Machines, Labeler Machines, Vial Washer Machine, Branson Ultrasonic System and Injection Molding Machines, Ovens, Filling and Close Machine). Mova Pharmaceuticals, Caguas, Puerto Rico Performed Performance Qualification for Depyrogenation Tunnel. This included temperature distribution and temperature penetration profiles. IVAX Pharmaceuticals, Cidra, Puerto Rico Responsible for the validation activities (protocol development and execution) of a facility expansion that included IQ/OQ of Utilities (Boilers, Chillers, HVAC system, Compressed Air, Dust Collector), equipment (Compression Machines, Metal Detectors, High Shear Mixer Granulator, Milling Machines, Coating Machine, Vacuum Charging Systems, Blenders). In addition, performed Facilities Qualifications for new and remodeled rooms.

 

Contractor Engineer, Engineering Sales & Services – Dorado, PR

Responsible for performing equipment qualification and support the activities of the Engineering Capital Project group at Merck Sharp & Dome, Barceloneta P.R Developed and executed IQ/OQ protocols for chemical plant process equipment (tanks, pumps, reactors). Reviewed and updated P&I Drawings, supported the equipment and instrumentation purchase and field installation supervision.

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Peter specializes in welding and metallurgical engineer with 40 years industry experience in commercial nuclear power plant construction.

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