Engineer Project Manager
Resume:
Kevin W. White, PE
**** **** ***, *******, ** ***07
*****-*****@**.**.***
Profile Certified Lean Leader and Six Sigma Black Belt with over million dollars in project
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savings
*-**us years experience in manufacturing management with increasing roles and
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responsibilities
10-plus years experience as project manager in engineering across multiple disciplines and
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industries
Goal-oriented individual with strong leadership capabilities
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Organized, highly motivated, and detail-directed problem solver
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Proven ability to work in unison with staff, peers, and management
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Education M.B.A., University of South Carolina
B.S., Electrical Engineering, Clemson University
Relevant Experience & Accomplishments
Manage operations with cost of production over $150M
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Department Profit and Loss responsibility for overhead budget of $10.1M
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Oversight of 25% improvement in operating efficiencies, including 33% in labor variances
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and 22% in material variances
Sustained customer service level of greater than 98% through schedule attainment objectives
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Regularly lead department through successful regulatory audits, including authorities from
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ANVISA, the FDA, EMEA and GCC
Implemented successful transition of Syringe Packaging operation from 2-shift operation to 3
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shifts through recruitment of personnel, revision of procedures, and coordination of
resources.
Successfully managed and implemented $400,000 cost-savings project in reduction of fill
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volume variance utilizing Six Sigma methods and analysis
Incorporated 5S program at site to aid in Lean Manufacturing initiatives with sustained audit
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results above 90%
Championed extensive overhaul of plant Engineering Change Control procedure to facilitate
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improved documentation flow and approval processes
Management of multi-discipline projects ranging to $500K in capital, including:
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o Makeup Tank Clean-In-Place System
o Sterile Container Fill Verification System
o 21 CFR Part 11 Distributed Control System Upgrade project
Creation, execution and review of IQ/OQ/PQ validation protocols utilizing Good Automated
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Manufacturing Practices (GAMP)
Professional Licensed Professional Engineer in North Carolina – Certificate # 25440
Achievement Certified Six Sigma Black Belt
Certified Lean Leader
At-Large Member of the Board of Directors for the Carolina-South Atlantic Chapter of
the International Society for Pharmaceutical Engineers (ISPE)
Kevin W. White, PE *****-*****@**.**.*** Page 1 of 3
Employment COVIDIEN (formerly Tyco/Healthcare – Mallinckrodt), Raleigh, NC Since 2000
Production Manager 2006-present
• Responsible for management of a multiple-shift pharmaceutical
manufacturing operation for formulation, filling, sterilization and
packaging of plastic syringes and glass vials and bottles of contrast
media in an ISO class 5 sterile environment
• Oversee department of 149 employees for strategic implementation and
adherence of operating philosophies and objectives to meet corporate
and plant initiatives regarding quality, safety and financial performance
• Develop and manage the department capital and expense budgets to
meet plant financial goals, such as spending, transfer, material and
overhead variances
• Provide support to R&D and management of projects involving new
product development, scale up, stability, and clinical manufacturing
• Schedule operation to optimize raw material use, maximize asset
utilization, and maintain inventory of finished goods
• Ensure adherence to and compliance with current Good Manufacturing
Practices (cGMPs) and regulatory agencies
Production Superintendent 2004-2006
• Responsible for management of a multiple-shift pharmaceutical
manufacturing operation for filling, sterilization and packaging of
plastic syringes of contrast media in an ISO class 5 sterile environment
• Assure staff of 75 employees adhere to operating procedures and
processes, and that product quality is maintained at or above established
federal and international regulatory standards
• Ensure Core production schedules are linked and necessary resources
are utilized for weekly attainment
• Review Standard Operating Procedures and validation protocol for area
equipment and processes, revise as needed and ensure compliance with
current Good Manufacturing Practices (GMP)
• Coordinate investigations on process variations and deviations
• Work closely with maintenance, quality assurance, financial services
and HR in order to maintain quality and operate efficiently
Engineering Manager 2003-2004
• Management and supervision of plant engineering staff and instrument
mechanics for facility
• Responsibility of plant control system projects and plant
instrumentation calibration and maintenance
Controls Engineer 2000-2003
• Oversight of configuration and maintenance of plant Distributed
Control System (DCS) and Programmable Logic Controller (PLC)
equipment
• Coordination and management of the calibration requirements for 1300
instruments throughout facility
INTERNATIONAL PAPER COMPANY, Roanoke Rapids, NC 1999-2000
Senior Controls Engineer
UCB CHEMICALS, North Augusta, SC 1995-1999
Automation Controls Engineer
ROBERT E MASON COMPANY, Charlotte, NC 1993-1995
Kevin W. White, PE *****-*****@**.**.*** Page 2 of 3
Systems Engineer
Kevin W. White, PE *****-*****@**.**.*** Page 3 of 3
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