Name: Kevin Harris
Home Location: US-PA-Furlong-18925 (US Citizen)
Will Relocate To:
Most Recent Title:
Experience: 19 Years
Most Recent Pay:
Sec. Clearance: NO
Start Date: January 1998 ~ End Date: January 2002
Company Name: eSpec
Job Title: eSpec/MES/CMS Product Manager
Start Date: January 1996 ~ End Date: January 1998
Company Name: Consilium
Job Title: Project Manager
Start Date: January 1995 ~ End Date: January 1997
Company Name: Jacobs
Job Title: Triad – Lead Automation Engineer/Project Manager
Start Date: January 1990 ~ End Date: January 1995
Company Name: McNeil Consumer Products
Job Title: Systems Engineering Manager
Start Date: January 1988 ~ End Date: January 1990
Company Name: Johnson Matthey
Job Title: Principle Process Control Engineer
Start Date: January 1984 ~ End Date: January 1988
Company Name: The West Company
Job Title: Senior Process/Project Engineer
Start Date: January 1983 ~ End Date: January 1984
Company Name: American Float Glass
Job Title: Plant / Project Engineer
Graduation Date:January 1983
Desired Pay: 120,000 USD per year
Travel Preference: Up to 50%
Provide systems / solutions to solve manufacturing and business problems.
Twenty years of diverse manufacturing systems implementation and project management experience, including fifteen years in the Pharmaceutical industry. Creative, results-oriented professional with strong expertise in business process re-engineering, process/packaging automation, manufacturing execution systems, clinical systems and computer system validation. Strong interpersonal and communications skills, with ability to interact effectively across multiple disciplines & organizational levels.
Honeywell-POMS – eSpec/MES/CMS Product Manager (1998-2002)
Responsible for the overall product definition for POMS eSpec (specification management), POMS MES (manufacturing execution system) and POMS CMS (clinical supplies management). Deliverables include product contract, requirements, process models, use cases, design reviews, press releases, white papers, product positioning, plus many others. Support sales activities, train sale personnel, lead due diligence for acquisitions, provide 21 CFR Part 11 expertise, and participate in Six Sigma activities.
Honeywell-POMS – Project Director
Responsible for successful (quality / schedule / budget) implementations of Manufacturing Execution Systems (MES) for many Pharmaceutical manufacturers. Train new hires. Support pre-sales efforts.
– Created Implementation Methodology (POMS FasTrack) and templates for related deliverables.
– Project Manager for multiple highly successful projects. Projects included weigh & dispense with SAP interface (3 sites), clinical supplies tracking system (1 site) and multiple material tracking.
– Deliverables include proposals, project & quality plans, validation master plans, requirements, designs, and testing (FAT, SAT, IQ, OQ and PQ). Lead requirements, design and testing activities.
– As Project Director, provided sales and implementation support for all clinical projects.
Consilium – Project Manager (1996-1998)
Responsible for successful (quality / schedule / budget) implementations of Manufacturing Execution Systems (MES) for multiple Pharmaceutical manufacturers. Manage and develop a staff of consultants.
– Created business assessment that identified up to $20 million / year in savings for a single client.
– Led multiple “As-Is” and “To-Be” business process re-engineering activities.
– Provided technical leadership for system design, development methodologies, and integration.
– Created multiple project plans, requirement and design specifications, and test documents.
Jacobs•Sigel•Triad – Lead Automation Engineer/Project Manager (1995-1997)
Responsible for managing, designing and implementing multiple Pharmaceutical process / packaging automation projects. Support MES implementation activities. Provide technical leadership for computer system validation of PLC, SCADA, & MES (POMs) systems.
– Created multiple Project Plans, Quality Assurance Plans, Validation Master Plans, Requirements Specifications, Design Specifications, Acceptance Test plans (FAT/SAT), and qualification protocols (IQ/OQ/PQ).
– Performed multiple source code reviews. Developed multiple Automation Master Plans.
– Created multiple Pharmaceutical packaging strategies and cost estimates (> $20 million).
J&J – McNeil Consumer Products – Systems Engineering Manager (1990-1995)
Responsible for managing the development and implementation of all PLC and SCADA based control systems for a $1.5 billion consumer products company. Supported MES implementation (Palette). Managed and developed a staff of engineers. Managed automation portion of capital forecast.
– $1 million savings from vendor negotiations and system design enhancements (MES Integration).
– Created Electrical, PLC, SCADA and documentation standards. Developed “in house” PLC training. Created and lead multi-site Manufacturing Execution Systems Best Practices team.
J&J – McNeil Pharmaceutical – Staff Automation Project Manager
Responsible for designing and implementing all PLC and SCADA based control systems for a $250 million pharmaceutical manufacturer.
– Designed, implemented and validated the following automated control systems: Fluid Bed Granulators, Microwave Granulator, Cream Processors, Coating Pans, Bosch Thermoformer.
– Designed, implemented and validated multiple Vision and Bar-code inspection systems.
– Enhanced computer validation guidelines and project management methodology. Created PLC and “C” programming standards. Performed multiple software vendor audits.
– Active member of J&J Computer System Validation Task Force. Provided certification training.
– Recognition included: McNeil Optimus award, J&J Achievement award, and three Quality at Work awards. Active member of 6 Statistical Based Continuos Improvement teams that saved McNeil over $2 million in yield improvements and $800,000 in material savings. As member of “Reduce Time to Market” SBCI team identified key roadblocks to the new drug development process.
Johnson Matthey – Principle Process Control Engineer (1988-1990)
Project Manager for $3 million project to “close the loop” in Auto Catalyst manufacturing process.
– Created approximately 50 P&IDs and project Requirements Specifications.
– Created CAD department, procured CAD hardware, trained drafters, and created standards.
– Performed GE PLC Series 6 and Basic Module programming.
The West Company – Senior Process/Project Engineer (1984-1988)
Responsible for the design, through start-up and training, of standardized computer-based control systems for all processes used in the manufacture of Pharmaceutical closures.
– Designed or assisted in the design of ten different automated process control systems, that were installed in over 100 machines world-wide. Including: Molding Presses, Autoclaves, Mixers, Dispensers, Calendars, and Vacuum Deposition Coating.
– Directed the mechanical redesign/refurbishment of existing rubber molding presses to integrate automated control system. Directed design and fabrication of utility cabinets / process skids.
– Interfaced automated process control systems to host computers for process traceability and supervisory control. Wrote over 50,000 lines of source code using real-time multi-tasking operating systems. Provided training for process engineers and plant maintenance personnel.
American Float Glass – Plant / Project Engineer (1983-1984)
Responsible for projects from conceptions through completion. Selected vendors, supervised up to 20 contractors and technicians, and trained operators.
– Installed $1 million computerized glass cutting systems, without any lost production time.
– Replaced every AC and DC motor and variable speed drive on a 900 foot long conveyor with minimal lost production. $1 million project.
– Reprogrammed off-line glass cutting system to improve productivity / cycle time.
– Designed new automated on-line glass stacking system to improve reliability / cycle time.
– Implemented periodic circuit breaker, substation and switchyard maintenance.
– Multiple continuous and batching instrumentation projects. Installed new nuclear level gauge.
1983 BSEE – Drexel University, Philadelphia, PA
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