Project Manager - Automation
Automation Engineering Professional with over 20 years supporting all aspects of process measurement and control in pharmaceutical manufacturing. He has efficiently and effectively worked with operational and maintenance staff, as well as guided subcontractors through corrective action and continuous improvement projects. He is highly regarded for exceptional technical writing, problem-solving, communication skills, and consistently achieving project goals. Gary is an expert in managing facility and equipment modifications using efficient project scope and planning techniques combined with change control planning and risk assessment. This has proved effective in project capital expenditure and budget requisitions. He has successfully commissioned all types of pharmaceutical equipment, laboratory equipment, utilities and facility modifications for industry leaders including Dow Chemical, Eli Lilly, Schein Pharmaceutical, Watson Pharmaceutical, Impax Laboratories and Bayer Life Science. His engineering expertise extends into all aspects of equipment commissioning beginning with authoring Functional Requirements, System Descriptions, Control System Descriptions, Software Descriptions, Factory Acceptance Testing, IQ and OQ Testing Protocols. He has filled multiple engineering and technical roles, including Process and Control System Design and Troubleshooting. His expertise extends into clean utilities engineering, design and installation of Pure Water, Clean Steam, Pure Air and Nitrogen distribution systems.
Gary is familiar with multiple programming languages and standards supporting PLC and SCADA development with Batch control and Historian data collection. Gary holds a BS in Biomedical Electronics Engineering (Summa Cum Laude) and Associates degree in Electronics and Computer Technology from DeVry University of Phoenix. He has served on multiple professional technical society executive boards, providing a very strong technical support network.
Pharma Automation Consultant
December 2009 – Present (6 years 3 months)Phoenix, Arizona Area
Provide Automation and Project Management services for Pharmaceutical, Biomedical, and Medical Device manufacturing facilities.
Biomedical Engineering Intern – Clinical Services
Banner Thunderbird Medical Center
January 2015 – March 2015 (3 months)Phoenix Arizona
Pharma Project Manager
2008 – 2009 (1 year)Phoenix, Arizona Area
Authored regulatory documents, oversaw construction and validation activities per master plan. Supported business development into Life Science industries. Provided Project management for solid-dose manufacturing validation activities in Taiwan, and Conducted Project Management oversight for multiple vendors for level 5 Bio-containment facility in China.
Sr Project Manager
Watson Pharmaceuticals – Steris Laboratories
2003 – 2007 (4 years)Phoenix, Arizona Area
Wrote project proposals to obtain capital expenditures for on-site projects. Managed on-site manufacturing equipment and facility modifications, including bringing in 3rd party contractor organizations for pure water and clean steam process modifications for CAPA resolutions. Specified, tested and commissioned Pharmaceutical manufacturing and facility equipment process improvements. Managed facility and manufacturing modifications using change control procedures, troubleshooting, and implemented process improvements. Performed factory acceptance testing for multiple new equipment purchases. Also organized and managed annual plant shutdown activities including everything from repairs, calibrations, facility modifications, passivation activities, etc.
Sr Project Manager
Schein Pharmaceutical – Steris Laboratories
2000 – 2002 (2 years)Phoenix AZ
Oversaw on-site manufacturing equipment and facility modifications to satisfy FDA consent decree requirements. Specified, tested and commissioned Pharmaceutical manufacturing and facility equipment. Provided Computer System Validation, supported facility and manufacturing modifications using change control procedures, troubleshooting, and implemented process improvements. Performed factory acceptance testing for multiple new equipment purchases.
Control System Engineer
1997 – 2000 (3 years)
Provided Computer System Validation, Instituted multiple PLC maintenance programs including documentation controls, battery replacement procedures, supported facility and manufacturing PLC modifications, troubleshooting, and process improvements. Performed factory acceptance testing for multiple new equipment purchases. Coordinated on-site millennium-rollover computer programs.
Control Systems Engineer / Field Engineer – Contract to Eli Lilly Co.
Jacobs Engineering Group
1990 – 1997 (7 years)Indianapolis, Indiana Area
Provided field engineering support for Process Plant startups and ICS lead for instrument and control specification, installation, testing and verification. Provided on-site support for multiple projects at multiple Lilly sites including Tippecanoe, Clinton, Greenfield, and downtown Corporate Headquarters.
Also updated controls and HMI for 7 autoclaves, conducted startup assistance and validation for CIP/COP systems, Freeze Dryers, and multiple bulk storage, distribution, and VOC recovery systems.