Project Manager Engineer
Resume:
MICHAEL D. BAIN
Harriman,TN 37748
********@*****.***
PROFESSIONAL PROFILE
Detail Oriented, Motivated Individual
Experience as Design Engineer,
Project Engineer, Project Manager
Career Overview
Merck Pharmaceuticals
Validation Engineer Consulatant January 2014 August 2014
. Validation Engineer for a large pharmaceutical company responsible for
installation validation and performance qualification for
manufacturing equipment and facilities support equipment.
. Responsible for startup and test runs for manufacturing cancer
treatment drugs. Ensure all documentation and validation
documentation prepared by startup team members if correct and
verified.
Confidential Client
Systems Engineer Consultant September 2011 November 2013
. Responsible for IQ/OQ of new process equipment and ensure all
equipment is installed correctly and ensure performance criteria are
met.
. Prepare and deliver all startup documentation and performance trends
are met and delivered to FDA inspectors.
Process Engineering Consultant November 2010 September 2011
Pharmaceutical Process Systems Validation Engineer
Confidential Client
. Commissioning And Validation Engineer for pharmaceutical processing
equipment. IQ/OQ of processing equipment, startup and operating
procedures training for plant personnel.
. Startup of equipment to ensure functionality and performance
requirements are met.
Tuchenhagen Systems Engineering, LLC July 1999 to January 2010
9160 Red Branch Road
Columbia, MD 21045
Senior Project Manager
Project manager and designer for manufacturing/process related capital
projects for pharmaceutical and beverage manufacturing plant process system
designs from conceptual to final design, installation, startup (IQ/OQ) and
training of plant personnel of system operation.
Develop system validation documentation, control system functional and
process specifications
Develop P&ID, equipment floor plans and installation drawings using
AutoCad.
Submit written project overview and project funding request including
presentation to capital project review committee.
Process engineering manager for support system design and installation of
spray dryer system for a large pharmaceutical manufacturer.
Responsible for design and installation, scheduling, maintaining budgets,
equipment procurement, review meetings with the customer.
Specify maintenance procedures for equipment and recommended spare parts
Manage project engineering department consisting of 15 project engineers
and process projects with budgets 1M - 15M.
Projects include having 3A, FDA, and GMP knowledge and meeting state and
federal regulations.
DSI Process Systems, Inc. October 1997- July 1999
405 Harbor Way, Woodstock, GA 30189
Corporate Office - 4630 W. Florissant Ave. St. Louis, MO 63115
Regional Engineer / Project Manager
Conveyor system designer for automated packaging system for cottage cheese,
sour cream lines.
Process design of steam pasteurization system for cottage cheese line
including steam filtration and instrumentation.
Develop equipment layouts and P&ID drawings using Autocad
Design 150 microsiemen Water System for ejecting contact lenses from mold
to package. Maintain schedule, develop IQ/OQ documentation, and develop
control system process description.
Capital Project manager for beverage and pharmaceutical manufacturing
process systems maintaining project timelines and budgets.
Experience in FDA approval documentation and requirements
Technical liaison for project engineering to determine cause and cure for
production and quality related issues and procure/recommend equipment or
design changes and initiate proper disciplines to mobilize and configure.
SESCO, Inc. March 1992 - October 1997
2145 Barrett Park Drive Suite 103, Kennesaw, GA. 30144
Project Engineer. Project Manager
Project engineer for evaporator system including budget, schedule, training
associates in system operation, installation and startup for a major food
manufacturing plant consisting of modifying existing processes. modifying
existing piping layout, relocating centrifuge systems and correcting piping
issues as to conform with FDA, 3A and USDA regulations to incorporate new
equipment and increase production output of plant.
Designed and managed system for unloading HFCS from railcars consisting of
utilities (steam, water, drains, overhead man-way access platforms) for
major beverage syrup manufacturer.
Develop process flow schematics and equipment floor plans, using
AutoCad, develop schedule and detail functional description for system
operation for plant personnel training
Construction/Site manager for installation and commissioning process
systems
General Dynamics-Electric Boat Division October 1983 - February 1992
Atlanta Engineering Office, Atlanta, GA Secret Clearance
Mechanical Designer, Piping and Ventilation systems for the US nuclear
submarine program
Designed mechanical torpedo handling systems for the TRIDENT program.
Liaison between disciplines to recommend corrective action for design
issues during construction phases including modified piping/ventilation
layouts, writing description of modifications and scheduling activities to
correct discrepancies.
Assigned to the inspection team to conduct on board inspections of piping
and ventilation systems to reconcile problems incurred while at sea trials.
EDUCATION
Tennessee State Technical Institute - Mechanical Engineering
Roane State Community College - Mechanical Design
SOFTWARE KNOWLEDGE/CONTINUING EDUCATION
AutoCad
AUTOCAD Advanced Teacher Training
Microsoft Word, Excel, Project, Power Point
Novell Netware CNE
Windows NT Server Operating Systems
Computervision CADDS 4x Mechanical Design
CADDS 2D and 3D Mechanical Design
Advanced Mechanical Detailing
Rockwell International - Goss Press Division Machine Design Apprenticeship
General Dynamics - HVAC and Piping Systems Design Apprenticeship
General Dynamics - Basic Nuclear Powered Submarines Apprenticeship
Contact this candidate