Francisco Leon, EIT                                                                                                                                                    

Validation Engineer

Frank is a Validation Engineer with over 13 years combined validation and production maintenance experience within the pharmaceutical industry. Equipment, utilities and facilities qualification experience includes development and execution of protocols for Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, Computer System Validation, and Performance Qualification.

EXPERIENCE…

• Executed IQ and OQ for solid dose, fluids, and ointments packaging equipment (Unscrambler, Filler, Capper, Pledget Packager, Marsh Printer, Label Printer, and Bar Code Scanner).
• Wrote and executed Site Acceptance Test (SAT), IQ, OQ and Computer System Validation (CSV) protocols for solid dosage packaging equipment (Bottle Feeder, Snap Capper, Neckbander, Cartoner Shrink Wrapper, Case Packer).
• Wrote and executed equipment IQ and OQ protocols for solid dosage packaging line equipment as well as Performance Qualification of solid dosage presentations (tablets, capsules) used in bottle and blister packaging lines.
• Wrote and executed PQ protocols for solid dosage presentations (tablets, capsules) used in bottle packaging lines.
• Wrote and executed Engineering Studies to determine the operational ranges of packaging line equipment.
• Executed IQ for process equipment (centrifuges, hydrogenerator, extractor, still) used in the elaboration of parenterals dosages.
• Reviewed computer application test scripts and participated in the validation of the computer application (Patient/Doctor/Pharmacy Registration Database / Integrated Voice Response System).
• Wrote SOPs required for the validation of MAXIMO computerized maintenance management system.
• Executed IQ for both storage and manufacturing tanks.
• Participated in the execution of Facilities Qualification protocols for compressed air systems, USP water system, HVAC and gowning areas.
• Developed software and hardware Change Control documentation related to the qualification of a Distributed Control System (DCS) of a pharmaceutical chemical plant facility.
• Performed Computer System Validation for a new pharmaceutical manufacturing facility.  The system included Supervisory Control and Data Acquisition (SCADA) Intouch Wonderware and RSView programming.  The new system architecture combined the use of data servers, process and utilities I/O servers, industrial computers, workstations, and PLCs.
• Wrote and reviewed Equipment Specifications documents, Installation and Operational Qualification protocols, and Summary Reports of solid dosage, fluids, and ointments packaging equipment.
• Performed preventive maintenance, technical troubleshooting, mechanical adjustments, and repairs of computerized equipment, pneumatic systems, and custom made machinery used in the manufacturing of blood and respiratory filtration devices in a medical device environment.

POSITIONS HELD…

• Validation Engineer                                                                   BioTeknica
• Validation Consultant                                                                Steelex
• Validation Consultant                                                                Washington Group
• Production Maintenance Technician                                         Pall BioMedical
• Staff Sgt.  Avionics Navigation Systems Spec.                       United States Air Force 

EDUCATION

• Bachelor of Science in Civil Engineering                                  Polytechnic University of Puerto Rico
• Certified 21 CFR Part 11 Professional                                      Stelex University
• Aviation Electronics                                                                  United States Air Force Technical Training School
• Electronics Technology                                                            Miguel Such Vocational School

CONTINUING EDUCATION…

• Engineer-In-Training (EIT) Certification No. 19333, Puerto Rico
• Introduction to 21 CFR Part 11
• Validation of Computer Systems Part 11 Compliance IT Infrastructure & 21 CFR Part 11
• Compliance & Remediation Strategies for 21 CFR Part 11
• Good Manufacturing Practices
• Good Documentation Practices
• Technical Writing
• Certifed Design Control/Validation