Expertise

More than 20 years of operations and engineering with a focus in the healthcare/pharmaceutical industry; 6 years of post-graduate education in engineering and business; 8 years with top operations management consulting firms. Expertises in:

• Manufacturing Facility Commissioning
• Pharmaceutical Process Validation (PV)
• Equipment Validation (IQ/OQ/PQ)
• Clean room Certification
• Preventive Maintenance Programs
• CMMS Implementation
• Quality & Reliability Training/Management: ASQ Series
• Business Operators Performance Improvement: Baldrige & 6 Sigma Implementation
• Manufacturing Strategy: Capacity & Consolidation
• Warehouse and Material Management
• Energy & Utilities Operation & Conservation

Experience

2002 - Present Consultant

• As an FDA designated consultant, certified that the production equipment and processes used to manufacture sterile and non-sterile drug products have been qualified and validated by the client, including the IQ/OQ/PQ/PV phases of validation for Process Equipment, HVAC, Water, Filling & Packaging and Bulk Manufacturing, according to 21 CFR Parts 210 and 211 (cGMP).
• Provided content expertise in clean room certification.

1994 - 2002 Performance Excellence Partners

• Consulting services focused on Performance Excellence across all business processes, including Customer Focus, Strategy, Organization, Methods, Processes, Systems, Metrics and Results.
• Provided expertise in identification of opportunities, program design and solution implementation in order to reduce costs, decrease cycle time, improve customer service, and reduce defects.
• Chevron in El Segundo, CA, Planning & Scheduling: Assessed maintenance operations and identified opportunities for improvement for: delivered customized planner training course; designed best-in-class process map to support implementation.
• The University of Chicago, Facilities Management: Operations Manager for leading a staff of 80 responsible for 100 building campus of 5MM square feet serving a population of 10,000; restructured the organization; launched 5 Continuous Improvement Teams.
• Atlantis Diesel Engines, Cape Town Materials Management: Implemented a Continuous Improvement Program at; increased engine on-time delivery service levels from 70% to 95%; reduced inventories by 40%; rationalized implementation of MRP system.
• Forest & Paper Products Company, Procurement & Sourcing: Led the development of the purchasing database for competitive bidding for a $1B; delivered a 10% reduction in purchased goods cost; identified 5% reduction in electric power purchase.
• Reliance Industries, Bombay, Reliability Focused Manufacturing: Led the assessment of petrochemicals operation using Overall Equipment Effectiveness (OEE) concepts; identified $25MM in profit improvement and an increase in plant throughput of 12%.

1988 - 1994 A.T. Kearney, Management Consultant: Operations improvement support for Pharmaceuticals, Chemicals, Food and Consumer industries.

1977 - 1988 Abbott Laboratories: Provided support to Pharmaceuticals, Diagnostics, Fermentation, Nutritional, Hospital Products and Chemicals divisions. Spent four years in the International Manufacturing Division.

Honors & Publications

Education

• Ph.D. Industrial Engineering, Northwestern
• MBA Finance, University of Chicago
• MS Mechanical Engineering, Northwestern
• BS Mechanical Engineering, University of Iowa
• Licensed Professional Engineer (PE)
• ASQ Certified Quality Engineer (CQE)
• ASQ Certified Six Sigma Black Belt (CSSBB)