FDA Consultant and Procurement and Sourcing Expert (1124)
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.
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)