Eduardo has 2 years of experience in engineering and manufacturing in the pharmaceutical and medical device industries. He also has expertise in the development and execution of validation protocols.
- Delivered full validation projects crucial to the manufacturing of medical devices, including:
o Installation Qualification (IQ),
o Operational Qualification (OQ)
o Performance Qualification (PQ)
o Completion Summary Reports
o Standard Operating Procedures (SOP)
o Preliminary Maintenance Standard Operating Procedures (PMSOP)
o Process Set-up Sheets
o Manufacturing Instructions (MI)
o User Requirements Specification (URS)
o Process Failure Mode Effects Analysis (PFMEA)
o Process Flow Diagram (PFD), Test Methods
o Quality Impact Assessment (QIA)
o Environmental Health and Safety Assessment
o Traceability Matrix
o Validation Plans
o Project Timeline
o Material Requisition Forms
o Change Authorization Forms
o Gage R&R
- Directed training activities for over 700 company employees on procedures introduced to the manufacturing floor.
- Saved half-million dollars annually in the use of low cost efficient raw materials.
- Led validation efforts for various pharmaceutical and medical device operations, including equipment commissioning and validation master plans.
- Developed engineering specifications and validated packaging equipment for medical device and pharmaceutical operations.
- Facilitated development of defect classification activities driven by failure mode & effects analysis.
- Created and implemented a new training program with 90% participation of employee population to enhance Good Manufacturing Practices.
- Increased machine production by 20% with the completion of time studies.
- Assisted in the introduction of Regulatory Asset Manager (RAM) program into the company for improvements of inventory control.
- Quality Engineer – BioTeknica, Inc.
- Manufacturing Engineer – CareFusion Corporation
- Engineering Intern – CareFusion Corporation
- M.S., Electrical Engineering – The University of Texas at El Paso
- B.S., Electrical Engineering – The University of Texas at El Paso