Rene is a quality professional with 11 years of progressive experience in the medical device and pharmaceutical industries. He has hands-on experience with engineering projects including validation commissioning, (IQ/OQ/PQ, & cleaning), quality improvement, incoming inspection, and equipment calibration/maintenance.
- Performed temperature mapping study evaluations for environmental clean rooms, warehouses and clean corridors.
- Developed and executed IQ /OQ /PQ for heating ventilation and air conditioning systems (HVAC) to support ISO class 7 & ISO class 8 environmental clean rooms.
- Performed remediation of entire calibration site instrumentation ensuring that all instrumentation met 4:1 calibration accuracy ratio and process range.
- Developed test method validation documents for attribute or variable inspection processes (i.e., incoming inspection and manufacturing processes).
- Developed and executed cleaning validation protocols for pharmaceutical manufacturing equipment.
- Developed cleaning validation procedures including identification of critical parameters for water flow, temperature, and pressure as well as wash and rinse times.
- Developed and executed installation, operation and performance qualification protocols for packaging equipment prior to equipment start-up.
- Developed standard operating procedures and trained staff required to successfully close out protocol qualifications (IQ/OQ/PQ) and final reports.
- Experienced with development of user requirement specifications, functional specifications, room qualification protocols, commissioning protocols and validation master plans for new and existing facilities and equipment.
- Experience with PLC backups using Siemens and Allen Bradley software.
- Performed hands-on trouble shooting for equipment used in parenteral manufacturing areas.
- Performed inspection and tested cardiovascular and interventional devices at various stages of process (i.e., incoming, sub-assembly, in-process, QA test, final QA).
- Responsible for maintenance of QA files (i.e. specifications, batch filing, history records, etc.)
- Closed protocol deviations as part of the equipment qualifications including corresponding corrective actions and resolution.
- Hands-on experience with the performance of equipment calibration and preventive maintenance for production equipment.
- Performed first and last piece inspection of thermoplastic resin panels and visual inspection of injection molded panels.
- Performed in-process inspection of advanced composite prepregs utilizing physio-chemical, mechanical, chemical, environmental, electrical, and flammability test equipment.
- Responsible for set-up and alignment of diverse production equipment as well as troubleshooting and repairing any mechanical and electrical problems encountered during production.
- Experienced with diverse measuring instruments including micrometers, calipers, headspace gauges, force testers such as Rockwell and Britnell, impact testers, and harness testers
- Validation Engineer – BioTeknica, Inc.
- Quality Assurance Technician/ Inspector/Tool Coordinator – Bolton Medical
- Quality Control Inspector – Nailite International
- In-Process QA Technician – Fibercote
- Industrial Mechanic – Coats North America
- Quality Control Inspector – Latecrete International
- B.S., Engineering Technology- Naugatuck Valley Technical College