1 Objective: To continue to build upon the skills I have obtained in the last fifteen years, particularly in the areas

of pharmaceutical regulatory compliance Work History: 2006-Present D and D Solutions, Inc., Belgrade, MT Position: President/Validation Consultant Duties include: Consulting services to the following companies: 2009-Present GlaxoSmithKline Biologicals, Hamilton, MT (subcontracted by ProPharma Group, Inc.) Position: Senior Validation Engineer Duties Include: Equipment and computer systems qualification for production and production support systems, including development of User Requirement Specifications (URS), Installation and Operation Qualification (IQOQ) protocols, and review/approval of executed IQOQ protocols in a new, one hundred million dollar production facility. Training client production support personnel on the execution of test protocols to ensure system testing fulfills regulatory requirements and industry standards. Remediation and corrective action of incidents encountered during qualification testing. Tracking and reporting status to management for the qualification activities of more than 250 individual pieces of production and production support equipment. Completing change control and remediation activities for major production systems, solvent delivery systems, and clean utility systems. 2008-2009 Medtronic Spinal and Biologics, Warsaw, IN (subcontracted by Maetrics, LLC) Position: Senior Validation Engineer Duties included: Computer system qualification of product assembly systems and purified water clean utility systems. Performing equipment assessments for regulatory compliance risk. 2007-2008 GlaxoSmithKline Biologicals, Hamilton, MT (subcontracted by ProPharma Group, Inc.) Position: Senior Validation Engineer Duties Included: Requisition and validation of 1.5 million dollars worth of new equipment. Ensuring project remained on schedule and on budget (completed all equipment requisition $180K under projected budget). Following up with vendors to arrange delivery and setup of equipment. Writing User Requirement Specifications (URS), and Installation and Operational Qualification (IQOQ) protocols. Performing commissioning and qualification of 150 new and existing pieces of equipment. Training client QC support personnel on the execution of test protocols to ensure system testing fulfilled regulatory requirements and industry standards requirements. Relocating existing lab equipment and completing all required requalification activities to release equipment for Good Manufacturing Practice (GMP) use. Assisting in the evaluation of change controls and subsequent validation protocol development and execution for changes to existing production facility on an as-needed basis. 2006-2007 PDL Biopharma, Brooklyn Park, MN (subcontracted by Computer Compliance, Inc.) Position: Senior Validation Engineer Duties Included: Evaluating change controls for regulatory impact to manufacturing systems prior to startup of new, two hundred million dollar production facility. Developing and executing test scripts, managing deviations, and preparing final reports to ensure that systems

maintain status as qualified systems. Providing input and recommendations for changes to facility automation validation program based on principles of pharmaceutical cGMPs, GAMP 4 guideline, and FDA guidance and requirements publications.

2004-2006 Computer Compliance, Inc., Bozeman, MT Position: Senior Validation Engineer Duties Included: Lead Engineer for completion of computer system validation of purified water generation system, as well as media and buffer preparation, hold, and feed systems. Generation and review of validation test plans, System Requirement Specifications (SRS), Functional Requirement Specifications (FRS), computer system IQOQ protocols, qualification final reports, traceability matrices, risk assessment documents, and part 11 assessment documents for manufacturing support systems, process utilities, purification and recovery systems, bioreactors, centrifuges, and Clean-inPlace (CIP) systems. Execution of computer system validation IQOQ protocols for Kaye Validators, Building Automation and Monitoring (BAS/BMS) systems, laboratory temperature and humidity-controlled storage systems. Maintaining Process Control System (PCS) server and workstation security, backup and recovery, batch journal reporting, and data library. 2003-2004 Computer Compliance, Inc., Bozeman, MT Position: Lead Automation & Validation Engineer Duties Included: Computer validation deviation correctiveaction investigation and associated troubleshooting and repair of Programmable Logic Controller (PLC) and Operator Interface Terminal (OIT) coding. Supporting related validation of bioreactors, CIP skids, ultra filtration, micro filtration, and chromatography systems. Execution of validation IQOQ protocols for automated data management system. 2002-2004 Industrial Automation Consulting, Three Forks, MT Position: Controls Engineer Duties Included: Designing and integrating control systems used in water/wastewater, electric utility, environmental monitoring, and industrial manufacturing applications. Generating documentation Turn Over Packages (TOPs), including as-built drawings, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Operation Manuals, and Operator Training Materials. Performing Programmable Logic Controller (PLC) programming for Allen-Bradley platform controllers. Assisting with HMI development using Rockwell and Wonderware platforms. Participating in onsite startup and commissioning activities, including operator training. 1995-2002 SCI Technologies, Inc., Bozeman, MT Position: Engineer Duties Included: Managing the design and manufacture of data acquisition systems (hardware and software) targeted for use in science education at the secondary and post-secondary level. Evaluating and implementing changes to manufacturing to maximize efficiency, reduce cost, and increase production throughput. Creating and maintaining all internal documentation such as manufacturing instructions, as well as all operation manuals, online help files, and training materials distributed with full product line. Hiring and managing staff to perform onsite manufacturing, calibration, and testing of product line. Interfacing with outside contractors for application software design, new product hardware design, and turnkey manufacturing solutions to supplement in-house capacity. Providing on-site and remote technical support and training. Providing remote workshop training for teachers using our data acquisition systems.

Interfacing with potential customers in convention settings throughout the United States. Maintaining and managing company network, servers and workstations, email systems, and phone systems. Education: B.S. in Electrical and Electronic Engineering Technology, 1996, Montana State University Professional Training: Lean Project Delivery: Leveraging the New ISPE Guides on Commissioning and Qualification and GAMP5 Rockwell Software RSView SE Programming (2004) Rockwell Software RSBizWare Batch Course 1-Batch Server and Configuration Tools (2004) Rockwell Software ControlLogix Maintenance and Troubleshooting (2004) References: References can be provided upon request.