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Ruben Capo                                                                              

Project Mgr./Sr. Quality Engineer

Ruben co-Founded BioTeknica, a firm that provides multi-disciplined engineering services. He has 19 years of experience in engineering and manufacturing in the pharmaceutical/biomedical//medical device industry.  Responsibilities have included design, development, installation, and validation of large-scale equipment and process validation. Ruben has designed and developed automated systems for in-line weight checks (including SPC monitoring), liquid level, and in-line sampling during filling/capping/labeling operations.   He is highly skilled with PLC systems (for example, Allen Bradley, Siemens, Modicon, etc.) design and troubleshooting.  

EXPERIENCE ...

• Developed Master Validation Plans and led the validation teams for numerous pharmaceutical and medical device manufacturing companies.
• Hands on turnkey validation experience with facilities, utilities, equipment, software, and processes utilized in the pharmaceutical and medical device industries.
• Designed and developed a custom automated control system, utilizing Allen Bradley technology, for large scale freeze dryers.
• Designed and developed custom equipment for the manufacturing and packaging of new products in a clean room facility for an IVD manufacturer.
• Designed automatic inspection, sampling and SPC monitoring of filling and labeling equipment to increase production efficiencies and product quality.
• Managed the transfer of large-scale lyophilization equipment including the de-commissioning, rigging, installation and troubleshooting, commissioning and validation.
• Developed equipment functional specifications (system requirements), prepared capital appropriation justification, installed new production equipment.
• Managed the refurbishment and validation of refrigeration and heat transfer media utilized for lyophilization.
• Developed operating and maintenance procedures for manufacturing equipment and processes.
• Managed Maintenance, Central Supply and Sterilization departments for a diagnostic reagent company.
• Developed and maintained manufacturing documentation systems.
• Participated in development of new product packaging.

POSITIONS HELD...

• Project Mgr/Sr. Quality Engineer                            BioTeknica, Inc.
• Staff Engineer                                                        Dade International, Inc.
• Associate Engineer                                                Baxter Diagnostic, Inc.                                  
• Unit Leader                                                            American Dade, Inc.
• Senior Engineering Technician                              American Dade, Inc.                                                  

EDUCATION...

• B.S.   Electrical Engineering                                   Florida International University

CONTINUING EDUCATION...

• Allen Bradley PLC5 and SLC500 Systems programming and troubleshooting
• Total Productive Maintenance (TPM)Train-the-Trainer
• 6-sigma quality/SPC
• Packaging Systems Validation workshop
• Design of bar-code reading system workshop