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.
- 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.
- 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.
- B.S., Electrical Engineering – Florida International University
- 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