Bob Kuhl Email and Phone Number

I was invited into this company as an employee by two of the other founders who recognized that my skill sets would be beneficial to a start up company of this nature. Each individual wore many hats and all have had over 30 years experience in "quality run highly regulated corporations" mostly within the United States. In January of 2013, I was invited to become a Principal of this corporation. In the first 9 months of business we provided $1.4 million in Engineering and Consulting Services. Our primary areas of engineering design are to Electrical Transmission and Distribution Service Providers. In 2014 we added a Construction Management Operation and in 2015 we have expanded our partners to a second office headquartered in Georgia. We are on track to grow our business again this year with a potential consecutive 50% year on year growth. Currently employ a total of 40 full and part time employees. Have met and worked with some outstanding dedicated people while constantly learning more about this industry while adding value and insight from my prior work experiences. Working hard and having a blast! Just made the Board of Directors!

Held the lead role in managing the Manufacturing Department and grew production to 1.5 billion tablets with approximately the same number of people as that in 2002.Integrated and embedded DDS (Demand Driven Supply) Practices; Used Value Stream Mapping and 5S tools to drive efficiency improvements and Waste Reduction through LEAN Activities while also dramatically improving Product Yields, Product Quality, and Customer Service levels. This high quality consistent process approach also helped to reduce inventory levels across parts of the supply chain that resulted in $14 million of savings in 1year.

Project Manager to Facilities (Maintenance Module). Project Manager to the mySAP Validation effort. Designed, tested, validated, and trained others in TDMS (Technical Document Management System) support program for PM (Preventive Maintenance) Checklists. This program was used as the Electronic Records / Electronic Signature application in place of the SAP-Workflow module.Selected as the MySAP-Business Prep and Cutover Lead for the Facilities Module and also the overall AZ representative mySAP enterprise management Cutover Lead for the Newark Site.

Managed the Manufacturing Department that was responsible for tablet production of one billion tablets per year. Held direct responsibility for 45 people and an annual budget of over $5.5 million. Maintained oversight responsibility for Process Equipment replacement and selection within the site Capital Program.Participated in the implementation of new processes and new product introductions such as Seroquel, Seroquel SR, and Iressa from "Scale-up Activities" and Tech Transfer Projects and Protocols. Established strategic plans and capacities for International Supply Chain Teams, and the U.S. Business, then implemented these plans into the Newark Site.

Managed internal and contract validation resources as well as helped establish the newly formed Compliance Department in order to bring the site into regulatory compliance. Directed and managed validation policy, procedures, training, validation planning, protocols, and change control for equipment/facilities qualification, process, computer, and cleaning validation.Successfully progressed the site into total validation compliance within a 30 month time period. Prepared for, participated in and presented data and philosophy in numerous regulatory inspections, audits, and PAI's for FDA, MCA

Planned, implemented and controlled validation activities on this $25 million aseptic powder filling facility, as well as contributed to facility design and equipment selection. Progressed validation activities from project conception through equipment procurement up to equipment and facility qualification.