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CENTER FOR RAPID RESPONSE ENGINEERING® SOLUTIONS

ENGINEERING AND SCIENTIFIC CONSULTING SERVICES

Resume of MRT
Consultant

EXPERTISE AND SERVICES

Verification, Facilities Qualification, Expert Consultant
Expertise in validation, IQ /OQ executions and other testing related to the validation process.

This consultant specializes in execution of qualification documents of new clean room facilities. In addition to validation activities, and document review, this consultant is an experienced quality engineer, with background in training personnel and performing departmental audits.

This consultant also offers expertise related to performing time studies and line balancing

PRINCIPAL INDUSTRIES SERVED
Pharmaceutical, Medical, Manufacturing, Electrical

EDUCATION
B.S., Industrial Engineering, University of Puerto Rico, Mayaguez Campus

PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.

Providing expertise in industrial engineering, quality engineering, pharmaceutical consulting, utilities and facilities qualification / validation, clean room and water purification qualification, and related expertise to a wide variety of clients.

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Case Studies

Validation Engineer, pharmaceutical manufacturing firm

Executed the qualification documents of the following equipment: Ribbon Blender, Torque Machine and Metal Detectors. Coordinated the validation activities, document reviewing. Executed IQ/OQ protocols. Solved and investigated deviations found during qualification activities. Involved in development and routing of final reports. Gave support to the technical services department. Gave support to packing line protocol execution.

Qualification Consultant, Filter Manufacturing Facility, Pall Life Sciences, Fajardo, Puerto Rico

Responsibilities included the execution of the qualification documents of the new Clean Room facilities. This qualification included Utilities Verification such as: electrical, shop air, pharm air, high vacuum and hose vacuum. It also included material of construction verification and environmental monitoring. Coordinated the validation activities, document reviewing. Executed the facility qualification protocols. Developed the Final Report. Solved and investigated deviations found during qualification activities. Executed the re-qualification documents of the equipment used in the secondary area of Kleenpak nova such as: Laser marker, Leak Tester, bag sealer, T-Platen Welders and Induction welder. Coordinated the validation activities, document reviewing. Executed the IQ/OQ protocols. Involved in the development of Final Report. Solved and Investigated Deviations found during qualification activities.

Qualification Consultant, Patheon Mova, Manati, Puerto Rico

Responsibilities included development and execution of the qualification documents of the following equipments: Hata Tablet Press Machine, Eliza Test 3+ tablet vision system, Metal detectors, Russell Sieve machine, Drum crusher and Ultrasonic Cleaners. Coordinated the validation activities, document reviewing. Developed the qualification documents. Executed IQ/OQ protocols. Solved and investigated deviations found during qualification activities. Was involved in the development and routing of final reports. Gave support to the technical services department.

Qualification Consultant, Filter Manufacturing Facility, Pall Life Sciences, Fajardo, Puerto Rico

Responsibilities included execution of the Qualification documents of the new purified water system. This System included equipments such as: Duplex Softeners, Duplex RO units, Duplex Mixed Bed, Ozone Generator, Ozone Destructor, Degas module and UV lights. Coordinated the validation activities, document reviewing. Executed the IQ/OQ protocols. Executed the qualification documents of the equipment used in the secondary area of Kleenpak and Kleenpak nova such as: Laser marker, Spin welders, Leak Testers, Burst test and bag sealers machines. Coordinated the validation activities, document reviewing. Executed the IQ/OQ protocols.

Industrial Engineer, Breaker manufacturing facility, General Electric, San Germán, Puerto Rico

Performed time studies and line balancing to reduce inefficiencies in the AFCI manufacturing line. Performed and implemented a new lay out for the manufacturing line. Coordinated the time studies activities. Analyzed data to perform line balancing. Performed layouts alternatives.

Quality Engineer, Filter Manufacturing Facility, Pall Life Sciences, Fajardo, Puerto Rico

Standardized all department metrics including PVRs and CORs. Trained personnel. Performed audits in all departments. Worked with equipment procedures and update them. Executed OQ test and stress test of the Criterion Vantage Acquire program used to SPC monitoring. Worked with non-conformance and supported investigations of customer occurrence.

PROFESSIONAL AFFILIATIONS
Six Sigma Black Belt Certification (on going)
CAPA Root Cause Analysis for FDA Regulated Industries Training

Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.

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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax

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