- Pharmaceutical Process Validation (PV)
- Equipment validation (IQ,OQ,PQ)
- Cleanroom certification
- Pharmaceutical Preventive maintenance programs
- CMMS (Computerized Maintenance Management Systems) implementation
- Quality and reliability, training management: ASQ Series, Certified Quality Engineer
- Business operators performance improvement: Baldrige and 6 Sigma Implementation
- Manufacturing strategy: Capacity and consolidation
- Pharmaceutical warehouse and material management
- Energy and utilities; management, operation and conservation
- Process capability analysis - SPC
- Lean and cellular manufacturing
- Maintenance - facilities and engineering
- Capacity and consolidation analysis
- Building commissioning
- TPM (Total Productive Maintenance) for operators.
Undisclosed Company, Operations Management Consultant, 2010 - Present
- Turnaround of a 500 person consumer goods packaging operation; filled in during search for new manager over 2-month period.
- Assessment of 26 mechanics and disciplinary processes; re-implementation of an abandoned PM program, initiate corrective action on top 10 sources of equipment failure; initiate PLC programming repairs on 12 packaging lines; initiate temporary staffing and 7 permanent hires; implement downtime tracking and root cause analysis for each packaging line; measuring ramp-up cycle times; complete baseline assessment and work plans for 12 month improvement program.
- Global Asset Change Control (ACC) Program: Supporting major pharmaceutical company with 23 manufacturing locations to implement a global SOP for asset change control.
- Design status report protocol, survey 5 locations in the Americas bi-weekly and report implementation progress. Developed ACC baseline assessment tool and follow-on ACC workshop to support implementation.
- Capital rationalization and capacity assessment: Definition of 5-year supply chain strategy for a generics pharmaceuticals manufacturing (3 sites); project scope included definition of corporate imperatives through executive focus interviews, an external scan of the competitive landscape to identify industry trends.
- Managed the "as-is" assessment of manufacturing capacity vs. 5-year product focus which determined that existing manufacturing capacity was adequate to handle the forecast, with operations improvements, without the cost of a new factory ($375 million); 17 charter teams defined to close compliance gaps identified.
- Manufacturing baseline assessment: As a part of due diligence post-acquisition, performed a manufacturing baseline assessments of 3 solid oral dose manufacturing operations including: quality systems, engineering and maintenance, equipment condition, quality control laboratories, procurement, and S&OP (Sales and Operations Planning) processes.
- Developed gaps analysis and recommendations for closure to set stage for multi-year operations improvement effort.
- 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 and packaging and bulk manufacturing, according to 21 CFR Parts 210 and 211 (cGMP).
- Provided content expertise in clean room certification.
Shire Pharmaceuticals, Owings Mills, MD, Director of Engineering and Maintenance, 2008 - 2010
- Managed 3 departments with a staff of 60 in charge of facilities, maintenance, metrology, utilities, security, janitorial, and grounds.
- As Interim Director supporting this site in a transition to transfer products to 3rd party and planning for site closure.
- Site continued to break safety records; training compliance was up from 84% to 93%; reduced manpower by 18% through task consolidation and elimination of open positions; and eliminated environmental excursions.
- Transition Program Leader: In addition to acting as Director of E&M, coached 5 teams in charter definition, work planning, execution and progress reporting to successfully launch the transfer of 4 products from this facility.
- QA and QC; pilot plant; manufacturing and E&M: As leader of the E&M team, developed charters and work plans to reduce (47) staff, decommission (900) pieces of equipment and cancel licenses and permits over the two year period.
- Initiated equipment sales; emptied (2) off-site storage locations; completed space planning for a facility in transition.
Quantic Regulatory Services, Livingston, NJ, 2002 - 2004
- GMP validation: 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 and packaging and bulk manufacturing, according to 21 CFR Parts 210 and 211 (cGMP); provided content expertise in HVAC operations and clean room certification.
Independent Consultant, 1997 - 2008
Pasadena Refining (Petrobras)
- CMMS/EAMS implementation: Acting as owners representative and program architect, provided change management leadership support for the launch of a Maximo Enterprise Asset Management System (EAMS) for refinery operations management.
- Formed teams, planned program, developed communications strategy, and embedded change through formal training, job descriptions, and metrics.
- Integrated the operations, maintenance, procurement, and accounting departments; startup achieved 2 months ahead of schedule.
- Lean manufacturing and optimization: Implemented Lean in a 350-person biotech manufacturing operation. Launched improvement teams, defined product families, documented value streams, established KPI metrics, implemented daily schedules, visual display boards, and TAKT (Taktzeit-meter) boards.
- Redesigned work cells. Launched 3 Kaizen events. Achieved 22% throughput increase with existing staff.
- SKU (Stock Keeping Unit) rationalization project launched to save $1 million per year.
- MRO (Maintenance, Repair, Operations) purchasing: Spend database team lead for a strategic sourcing project.
- Led the development of the spend database for a $1 billion in pulp and timber products company.
- Identified cost and what was purchased, by location, from a database of 125,000 purchase orders.
- Reduced the cost of procurement by 15%; identified a 5% reduction in electric power purchase by taking advantage of better rate structures.
The University of Chicago
- Facilities management: As acting Director of Operations for The University of Chicago leading a staff of 80 responsible for 100 building campus of 5MM square feet serving a student population of 10,000.
- Restructured the maintenance organization; resolved steam plant reliability issues that had shut down the entire campus; launched 5 continuous improvement teams.
- Maintenance planning processes: Assessed refinery maintenance operations and identified opportunities for improvement; Designed and delivered a one-week maintenance planner training course; designed process map to guide implementation of change.
Gemini Consulting, Morristown, NJ , 1994 - 1995
- Materials Management: Atlantis Diesel Engines, Republic of South Africa: Implemented a continuous improvement program within the materials management function; Increased engine on-time delivery service levels from 70% to 95%; reduced inventories by 40%: Rationalized implementation of MRP system in order to reduce the cycle time of daily schedule update; implement plan-do-review with team centers.
AT Kearney, Chicago, IL, 1988 - 1994
- Operations management consultant supporting numerous industries: Pharmaceuticals, Refining, Chemicals, Food and Consumer.
- Functions included maintenance, quality, manufacturing and supply chain; assignments included; benchmarking, cost reduction, capacity and consolidation, continuous improvement, purchasing, reengineering, activity-based costing, CMMS Implementation, uptime Improvement, and inventory management.
- Led a team of 3 consultants in assessing the manufacturing operations of 2 GM manufacturing plants; Identified $60 million cost reduction on cost base of $250 million.
- Opportunities included streamlined organizational structure, reduction in the cost of quality, maintenance productivity, synchronous manufacturing and uptime improvement.
- Managed 4 consultants and a team of 100 client staff to implement changes over a 12 month period.
- Operations assessments: Member of team that assessed manufacturing operations of $4.7 billon automotive parts manufacturing division, (Inland Fisher Guide) whose operating profits were negative.
- Performed 1-week assessments at 6 of the largest plants and performed capacity and consolidation analysis on seven plants that resulted in the recommendation to close two locations.
- Overall recommendations identified $1.2 billion in cost reduction along with closing 7 of 23 locations and exiting $275 million non-profitable business. Improved gross profits to 24%.
- Maintenance management systems: Redesigned and implemented maintenance work processes for Canadian petrochemicals operation; work backlogs were reduced by 80%; contractor workforce of 120 eliminated due to improved internal productivity.
- Reliability focused manufacturing: Led the assessment of Reliance Industries (Mumbai) petrochemicals operation using Overall equipment effectiveness concepts; identified $25 million in profit improvement and an increase in plant throughput of 12%.
- Maintenance management: Assessed Upjohn (Pfizer) chemicals division, 520-person maintenance operation; measured effectiveness at 26% vs. objective of 60%; identified $15 million opportunity.
- Re-focused organization from functional to customer focused teams.
- Benchmarking: Surveyed manufacturing practices of Boise Cascade's 5 pulp and paper mills and compared findings with industry leaders; recommendations included the addition of 17 planners and engineers in order to increase mill uptime and yield.
- Maintenance reorganization: Designed new organization for the downsizing of Dole Foods 250-person maintenance support organization in Honolulu, HI.
- Outsourced common tasks to local suppliers formed central planning group, implemented systems support and designed and implemented planning processes; Manpower reduced by 40%.
- Manufacturing strategy: Developed strategy for a $200 million division for medical devices division of Baxter International.
- Refocused operations into separate high-volume or low-volume manufacturing; activity-based costing analysis showed that 55% of product gross margins were in error by more than 50%.
Abbott Laboratories, North Chicago, IL, 1977 - 1988
- Operations management: For this $14 billion health care products supplier; provided support to Pharmaceuticals, Diagnostics, Fermentation, Nutritional, Hospital Products and Chemicals divisions.
- Four years in the International Manufacturing Division; held positions as Project Engineer, Plant Engineer, Energy Engineer and Maintenance Manager; created, staffed, and managed a 15 person environmental (HVAC) support group for pharmaceutical manufacturing, bio-hazardous operations and clean room (HEPA) certification.
Honors & Publications
- Certified in Production and Inventory Management (CPIM), APICS
- Certified Quality Engineer (CQE), ASQ 2004
- Certified Six Sigma Black Belt (CSSBB), ASQ 2005
- Examiner, New Jersey Award for Performance Excellence (Baldrige)
- Professional Engineering License
- Ph.D. Industrial Engineering - Operations Management, Northwestern University, Evanston, IL
- MBA Financial Analysis, University of Chicago, Booth School of Business, Chicago, IL
- M.S. Mechanical Engineering, Thermodynamics, Northwestern University, Evanston, IL
- B.S. Mechanical Engineering, University of Iowa, Iowa City, IA