Process Plus, June 2010 - Present Cincinnati, Ohio
Validation Specialist/Engineer/Project Lead
• Qualification of high containment pharmaceutical equipment including Single Pot Processors, Roller Compactors, Comils, Tablet Presses, Isolators, Encapsulators, Bin Tumblers / Blenders, and Blister / Bottle Packaging equipment.
• Project lead from startup to close out on a full solids packaging line including equipment testing at vendor sites and full qualification at owner site.
• Developing Standard Operating Procedures (SOP), User Requirement Specifications (URS), Trace Matrices (TM), Functional/Design Specifications (FS/DS) for pharmaceutical process and packaging equipment, supporting utilities, electrical control systems, and HVAC / Environmental Control Systems.
• Developing and executing Installation/Operational/Performance Qualifications (IQ/OQ/PQ) protocols and commissioning documents for pharmaceutical manufacturing facilities, lab equipment, electrical control systems, process and packaging equipment, supporting utilities, and HVAC / Environmental Control systems.
• Creating Validation Summary Reports (VSR) following validation activities of pharmaceutical grade equipment and utilities.
• Planning and executing construction segregation plans (CSP) for cGMP production areas.
• Developing and executing Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) protocols.
• Development and planning of Validation Master Plans (VMP).
• Inspection of Process and Instrumentation Diagrams.
• Proposal development, estimating, and project leading.
• Development and execution of temperature mapping protocols and studies.
PharmaForce, Incorporated, June 2009 – June 2010 Columbus, Ohio
Validation Specialist/Metrologist
• Qualification of pharmaceutical equipment including autoclaves, dry heat ovens, terminal sterilizers, utilities, purified water systems, compressed air systems, and pharmaceutical lab equipment.
• Performing of calibrations and preventative maintenance.
• Executing and developing IQ/OQ/PQ protocols and SOPs.
• Performing of process validation and cleaning validation.
• Sterile environment qualifications and monitoring.
• Design projects such as product manufacturing enhancements and room design.
• Validation of sterile products and sterile manufacturing equipment.
• Creating VSRs following validation activities of pharmaceutical grade equipment and utilities.
• Develop and execute temperature mapping protocols
Riverside Hospital, February 2009 - April 2009 Columbus, Ohio
Intern
• Shadowed Biomedical Engineer’s and learned equipment such as Dialysis, fraternal medicine, surgical, anesthesiologist, and patient monitoring.
• Performed preventative maintenance procedures on equipment.
• Completed repairs and qualification/testing of medical equipment.
EDUCATION
Thomas Worthington High School Worthington, Ohio
High School Diploma, 2006 Graduate
• Varsity Boys Golf Letterman
• Scholar Athlete
DeVry University Columbus, Ohio
Bachelor of Science, Biomedical Engineering Technology, 2009
• Dean's list Honoree for Academic Exc...
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