MICHAEL D. BAIN

*** ********* *****

Harriman,TN 37748

acflvs@r.postjobfree.com

410-***-****

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

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