Jorge Rodriguez                                                                             

Project Mgr/Sr. Quality Engineer

Jorge has seventeen years of experience in the pharmaceutical, medical device and diagnostics industry with experience in both instruments and reagents manufacturing. Jorge has led all facets of projects from conception, implementation, and validation.

EXPERIENCE...

• Performed validation of complex packaging machinery (ampule filling, robotic pick/place packaging, high speed cap/label, high speed filling w/ robotic check-weighing) including protocol development, execution and final report.
• Identified and implemented packaging process improvements that led to over $1.0 Million in annual savings for a leading Pharmaceuticals manufacturer.
• Performed validation of several building automation systems (software and hardware) that monitor and controls environmental conditions for a various classifications of cleanrooms for Class III medical device manufacturing facilities.
• Overall Validation QA responsibility including Master Validation Plan development and execution, Protocol Approvals, Final Report Approvals for a leading diagnostics manufacturer.
• Overall responsibility for all technical aspects of hematology instrument manufacturing process for three product lines in the focused factory.
• Conducted process validation of final test process for hematology analysis systems.
• Participated in “Blitz” Team that reduced manufacturing related discards and customer complaints by 50% for a leading medical device manufacturer by implementing process improvements in extrusion, component fabrication, and finishing areas.
• Managed $2MM budget and member of project team to consolidate 220K sq. ft. R&D facility including all supporting equipment (i.e. hoods, washers, sterilizers, tablet press, fluid bed granulator, refrigerators/freezers, etc.) and utilities (compressed air, vacuum, purified water, electrical, steam).
• Developed line balancing models using computer simulation programs to optimize efficiency and reduce overall cycle times.
• Overall project responsibility for the transfer of a $7MM/yr product line to European plant.
• Managed day-to day operations of bulking, filling, quality control, and materials planning groups for respiratory care product line.
• Conducted process flow analysis and develop improved methods of current systems.
• Developed storage capacity plans for WIP and finished goods inventories determining impact on overall plant refrigeration storage capacity.

POSITIONS HELD...

• Project Mgr/Sr. Quality Engineer                   BioTeknica        
• Senior Manufacturing Engineer II                  Beckman Coulter Corporation                             
• Senior Staff Engineer                                   Dade International Inc.                           
• Staff Engineer                                              Baxter Diagnostics Inc.
• Associate Engineer                                      Baxter Diagnostics Inc.
• Senior Engineering Technician                     Baxter Diagnostics Inc .                          

EDUCATION...

• B.S. Industrial and Systems Engineering    Florida International University
• A.A., Biology                                               Miami-Dade Community College

CONTINUING EDUCATION...

• Just-In-Time (JIT) Manufacturing Philosophy
• Pharmaceutical Water Systems Seminar
• Design, Operation, and Validation of Steam Sterilization Systems Seminar
• Contamination Control in Clean Rooms
• Statistical Process Control (SPC) - Six Sigma Quality
• HACCP – Hazard Analysis and Critical Control Points