Ruben Capo

Ruben Capo

Principal/Project Manager/Senior Quality Engineer

Co-Founder Ruben Capo brings 19 years of experience in engineering and manufacturing in the pharmaceutical/biomedical//medical device industry to BioTeknica.  His 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.  Additionally, he is highly skilled with PLC systems (for example, Allen Bradley, Siemens, Modicon, etc.) design and troubleshooting.

EXPERIENCE…

  • Principal, BioTeknica, Inc.
  • 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…
  • Principal/Project Manager/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