Pharmaceutical Software Engineer

Expertise

Specializes in consulting and project management for Supervisory Control and Data Acquisition (SCADA), System Integration and Industrial Controls including pharmaceutical industry regulatory compliance, 21 CFR Part 11 and controls for clean rooms. Specific expertise in :

• Good Automated Manufacturing Practices (GAMP).
• 21 CFR Part 11 Training. Computer Validation Training by PDA.
• PLC hardware and software
• Pharmaceutical Current Good Manufacturing (cGMP) and validation of computer software
• Good Automated Manufacturing Practices (GAMP) and Good Electronic Records Management (GERM) methodologies for compliance with FDA software regulations

Experience

• Consulting and project management for Supervisory Control and Data Acquisition (SCADA), System Integration and Industrial Controls including pharmaceutical industry regulatory compliance, 21 CFR Part 11 and controls for clean rooms.
• Strong technical background in SCADA and PLC computer-based industrial controls and networks.
• Extensive experience with hardware and software for Allen Bradley (Rockwell Automation) Programmable Logic Controllers (PLC & SLC), Wonderware and Intellution graphical interface products and ABB Distributed Control System (DCS).
• Experienced with Pharmaceutical Current Good Manufacturing (cGMP) environment and validation of computer software for Pharmaceutical and Biotechnology process controls.
• Expert with Good Automated Manufacturing Practices (GAMP) and Good Electronic Records Management (GERM) methodologies for compliance with FDA software regulations.
• Also experienced with contracting and competitively bid projects.,
• Expert witness on several cases involving control systems using PLCs, SCADA, ABB DCS, and patents for pharmaceutical process control computing.
• In major international consulting roles, arranged SCADA and Telecom procurement for $2 billion Greek pipeline.
• Performed analysis of Geographic Information Systems for Turkey for World Bank and US Trade Development Agency (US TDA).
• Performed analysis of Electronic Data Interchange (EDI) in Chile for UA TDA.
• For World Bank, reviewed plan by Poland for gas transmission SCADA project.
• Wrote procurement specification for backup SCADA for Saudi Electric Company East.

Honors & Publications

• 1 Patent
• Many published articles

Education

• BSEE, University of Washington, Seattle, Washington
• MSEE, University of Washington, Seattle, Washington
• Registered Electrical Engineer (P.E.), California