Project Manager Engineer
Resume:
Keith Lutz
Kirtland, Ohio 44094
*****.******@*****.***
CAREER SUMMARY
Professional Engineer and Project Manager with demonstrated expertise in
initiating, designing, and implementing improvements in pharmaceutical
process, specialty chemical systems, and building systems. Experienced in
creating value while conforming to the requirements of large and small
capital projects. Knowledge of regulatory requirements associated with
pharmaceutical manufacture, design and building of facilities and process
plants. MBA with pharmaceutical industry experience.
PROFESSIONAL EXPERIENCE
Ben Venue Labs, Bedford, OH - 2001-2009
Senior Project Engineer
Responsible for project management, equipment specification, design,
installation and commissioning of process equipment, facility projects, and
site improvements. Role included obtaining project acceptance with project
team including operations, maintenance, building contractors, and
Quality/Regulatory groups concerning scope, budget and schedule. Projects
included aseptic filling lines, terminal sterilizers, sterility test
isolators, inspection machines, HVAC renovations, and facility room
modifications.
. Coordinated installation, and commissioning of four aseptic filling lines
over five year cycle 2002 thru 2007 including vial washers,
depyrogenation tunnel, vial filling, and vial sealer; completed on
schedule, supporting qualification and regulatory filing schedule for
each line.
. Led multi-functional team to evaluate safety issues on vial washing
process. Facilitated the removal and replacement of Line 5 Tunnel-Washer
with a safety upgraded system during holiday 2007 shutdown.
. Directed Quality Improvement Team to revise equipment process, reducing
water consumption and saving more than $24,000 per batch.
. Designed and Commissioned Terminal Sterilizer Control Conversion to
eliminate the "loss of batch" associated with control blackouts.
Conversion installed, and qualified within ten day schedule, eliminating
risk of batch loss associated with products valued over 1 million dollars
during July 2006 shutdown.
. As Project Engineer, implemented design solution for facility renovation
of Formulation Suite to address operator exposure to cytotoxic powders;
completed on schedule during holiday 2005 shutdown.
STERIS Corporation, Mentor, OH - 1998-2001
Project Manager, Capital Equipment
Responsible for capital equipment projects in Eastern half of the United
States, Puerto Rico, and South America. Provided technical direction and
support to end users, field sales, and engineering firms with preparation
of proposals and presentations.
. Coordinated design and testing of a dual process terminal sterilizer for
a start-up pharmaceutical company, allowing replacement of competitor
equipment and satisfying end user qualification schedule.
. Directed testing and installation of custom water for injection
distillation unit, utilizing local water restrictions and leading to the
sale of a $400,000 unit.
. Supported ten regional field account managers with equipment proposals,
project fabrication and educational presentations.
Keith Lutz, Page Two
Middough Associates, Cleveland, OH - 1990-1998
Mechanical Project Engineer
Responsible for development of engineering scope, project requirements and
project proposals. Activities included coordination and preparation of
engineering drawings and design for process and facilities.
. Coordinated design fabrication and start-up of process line for Corning
Fallbrook Lead abatement project which included the renovation of the
facility and process; reduced operator exposure to air borne
concentrations of lead.
. Diagnosed problems related to successful facility expansion and
installation of renovated equipment for the Corning Refractory Expansion,
contributing to completion of project on time and within budget.
. Supervised the mechanical renovation of building systems to control
contractor scope change orders on the BFGoodrich Louisville, CPVC
Expansion. Directed the scope review and education of the contractors
relating to the specific design requirements and maintain piping package
budget.
MK Fergusson Engineers, Cleveland, OH - 1986-1989
Mechanical Engineer
Development of engineering specifications, project drawings and project
proposals. Activities included engineering drawings and design for process
and facilities.
EDUCATION
Master of Business Administration, Case Western Reserve University,
Weatherhead School of Management 1990
Bachelor of Science, Case Western Reserve Univeristy, School of Mechanical
Engineering 1986
PROFESSIONAL DEVELOPMENT
- Project Management Fundamentals, Continuing Education CWRU
- Team Building Fundamentals, Continuing Education CWRU
- Aseptic Process and RABS, International Society for Pharmaceutical
Engineers
- Potent Compounds Safe Handling Practice, International Society for
Pharmaceutical Engineers
TECHNICAL SKILLS
- MSWord, Excel, Power Point
- MSProject
- Risk Analysis, Failure Mode Evaluation and Analysis
ASSOCIATIONS/ORGANIZATIONS
- Professional Engineer, State of Ohio
- International Society of Pharmaceutical Engineers
COMMUNITY INVOLVEMENT
- President of Kirtland Soccer League 2004 thru 2009
- Youth Basketball Coach Willoughby 2004 thru 2009
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