Professional Summary
Problem solving Automation/Software/Manufacturing Engineer with extensive experience in process automation, technology transfer and manufacturing operations. Skilled in all areas of GMP manufacturing: development, prototyping, scale-up, commissioning, validation, process improvement and sustaining operations. Excellent communicator, bridging geographical and organizational boundaries to solve complex problems. Consistently enhances operations through creative thinking, collaborative action and process improvement.
Technical Proficiencies
• Automated Vision Inspection (Cognex/PPT/DVT/Adept)
• Programmable Logic Controllers PLC (AB/Rockwell/Siemens)
• Human Machine Interfaces HMI (Rockwell/Wonderware/LabVIEW)
• Manufacturing Execution Systems MES
• Sensing Technologies/Motion Control/Safety Circuits & Fail-Safe Operation
• Graphic Design (Adobe InDesign/Illustrator)
• Standard Office & Statistics Apps
• Software Development & Validation (CSV/GAMP5/CMMI)
Manufacturing Proficiencies
• Rapid Prototyping and Scale-up
• Technical Transfer (offshoring)
• Training and Certification
• LEAN/JIT/DFT Manufacturing
• 6 Sigma Process Excellence/ Design Excellence
• 5 S’s/Kaizan/Self-directed Work Teams
• CAPA/MRB/NCR/IR/DHR/SOPs/MWIs
Validation Proficiencies
• IQ/OQ/PQ protocol and report generation and execution
• Process characterizations/DOEs
• Factory Acceptance Testing
• Computer System Validation methodologies (CSV)
• Change Control Board administration
• Authored numerous franchise methods/SOPs
• Failure Mode Effect Analysis, Risk Analysis/CTQ Flowdown
Experience
Alexza Pharmaceuticals: Manufacturing Engineer (consultant) 6/2012-8/2012
Supported commercialization projects for capacity expansion, validation projects and quality and compliance projects. Led PLC/HMI & capital equipment projects. Analyzed validation projects and gap mitigations. Performed quality investigations & CAPAs projects.
QualComp Consulting: CAPA/QA Engineer (consultant) 5/2012-6/2012
Process and Equipment Engineering support for major CAPA reduction project for large Pharma Company in Puerto Rico. For a company operating under consent decree, I supported a large concerted effort aimed at quality and compliance improvement.
Cordis (Johnson & Johnson): Principal Process Engineer 2007-2011
Successfully led Technical Transfer: coordinating role for transfer of manufacturing operation from US to Ireland. Responsible for shipping, installing and validating a complete manufacturing process for drug eluting stents:
• FAT/IQ/OQ/PQ protocol authoring and execution, MES/EBR Implementation
• LEAN Manufacturing Layout Graphical Operati...
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