pharmaceutical, biotechnology validation specialist, expert consultant resume
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Resume of CHJ Consultant
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  • Biotechnology
  • Pharmaceutical
  • Manufacturing
  • Validation
  • Quality

This expert has a B.S. in Chemistry from the Turabo University in Gurabo, Puerto Rico.

Pharmaceutical, Biotechnology Validation Specialist, Expert Consultant Resume
 

This expert specializes in the pharmaceutical/biotechnology manufacturing environment. This consultant provides experience in validation, qualification, and commissioning environments involving critical aspects of facilities, utilities, computer systems and manufacturing equipment focused on product and process quality.

Additional experience of this expert includes coordinating personnel in the execution of protocols and gathering of test data in accordance with the client and GMP requirements. Specialization of this consultant includes writing and executing commissioning, validation and qualifications protocols that challenge the critical parameters related to installation, operation, and performance of the related systems

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in pharmaceutical and biotechnology manufacturing, validation, qualification, commissioning, product and process quality, and related expertise to a wide variety of clients.

 

Validation Specialist III, Avon Products Inc., Rye, NY / Morton Grove, IL

Performed Computer System Validation execution to ERP Oracle software. IBM JD Edwards Enterprise One (E1) application validation execution.

 

Validation Specialist III (Project Leader), Glaxo Smith Kline, Inc. Cidra, Puerto Rico

Performed commissioning and qualification activities to an automated Fluid Bed Drier. Performed commissioning and qualification activities of four automated suites of Solution Preparation systems. In charge of the coordination and execution of the mechanical and control system qualification for "Accela Cota 60 DXL" Coater System II and Wash in Place systems. Supervised the execution of validation activities and coordinate activities with the vendor and project managers to ensure that the project schedule and cost estimates are maintained. Assisted in resolving project delays and changes in order to comply with the customer satisfaction.

 

Validation Specialist, Pfizer, Brooklyn NY

PIAB Conveyor System IOQ protocol generation and execution. 340 Qt. Glen Mixer IOPQ /Commissioning protocol generation. Operational SOP generation. SRS/VCP generation. System/Component Impact Assessments generation. Automated Tablet Inspection System PQ execution.

 

Validation Specialist, Bristol Myers Squibb, Manatí

IQ/OQ Execution Spray Film Vapor Compression Evaporator Model PR1000 Distillation Unit and Pre-Treatment System. Commissioning document generation for Spray Film Vapor Compression Evaporator Model PR1000 Distillation Unit and Pre-Treatment System. Operational, Administrator and Security, and Back up and Restore SOP's generation.

 

Validation Specialist, Biovail, Dorado, PR

Qualification of Lock Met 30+ Metal Detector. IOQ Protocol generation and execution. O'Hara Labcoat III IOQ Protocol generation and execution (CSV). SDS/FRS/URS generation. Tablet Press System URS generation (Rotapress Mark IV). CSV- FETTE 2200 IQ/OQ execution. FETTE 2200 Operational SOP and TM generation.

 

Validation Specialist (Project Leader), Watson Pharma, Corona CA

HVAC/Dust Collector/Compressed Air and Facility modification protocol amendments generation and execution. Collette GRAL granulator and Vector Coater System protocol generation and execution. Glatt Mini-Fluid Bed Dryer/Granulator/Coater IOPQ Protocol generation. Dioxna Pharma P 1/6 Mixer IOPQ Protocol generation.

 

Validation Specialist (Project Lead), Watson Pharma, Gurnee, IL

IOQ Protocol generation and execution for a Pharmaceutical Distribution Center Facility. Size 232,000 sq. feet. IOPQ Protocol generation and execution of 18 units of HVAC System. IOPQ Protocol generation and execution for Pharmaceutical Cold Room. CSV-BMS IOQ Protocol generation and execution for HVAC Systems control. FRS/URS/Traceability Matrix generation.

 

Validation Specialist (Project Lead), Watson Pharma, Copiague, NY

CompuLab 36" Coating Machine IOPQ Protocol generation and execution. Delta Printing Machine IOPQ Protocol generation and execution. Ackley Printing System IOPQ protocol execution. Ingersol Rand Compressed Air/Hankinson Air Dryer System IOQ Protocol generation and execution.

 

Validation Specialist, Watson Laboratories, Humacao, PR

IQ/OQ Protocol generation and execution for Facility for Building 1 Phase. IQ/OQ/PQ Protocol and Final Report generation and execution of 100 cu.ft. Gemco Blender. IQ/OQ Protocol generation and execution for AC Unit 37 HVAC. CSV -IQ/OQ protocol execution for Glatt-60 Fluid Bed Dryer with Data Plus 2000 AF Control, System. SOP generation for Stokes Tornado Mil grinding, HT035E Tumble Dryer and Milnor Washer.

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FEATURED CONSULTANT

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

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