Millard Kram, P.E.
President
Mill started MKCS, Inc. in 1994 to provide system support for distributed control systems (DCS) in the pharmaceutical industry Greenville, N.C. That support consists of daily production, validation, and engineering support of the sterile products facility. Other responsibilities include designing, maintaining and upgrading the network systems and I/O. Mill has also been responsible for the implementation of the DCS for the sterile products facility expansion project. The project involved five 300 sq. ft. Freeze Dryers, an Automatic Vial Loading and Unloading System, and an Unloading Accumulation Buffer (UAB). Additional projects include implementing and supporting the compounding, filling, loading and freeze drying operations. More recently, Mill has been responsible for the implementation and commissioning of multiple lyophilization projects involving PLC and SCADA solutions.
Mill's experience at GSE Systems as a lead application engineer included implementing multi-million dollar projects for several food and pharmaceutical industry customers. Prior to GSE, Mill was employed at Texas Instruments semiconductor facility, supervising production personnel while managing PLC automation systems and projects. Mill holds a BS in Electrical Engineering from the Rochester Institute of Technology.
Joe Brower
Vice President of Operations
Joe began with MKCS in March of 2005. He joined MKCS, Inc. to support the everyday increasing project and production assistance. He is also responsible for the design, implementation, validation, and commissioning of aseptic processing facilities for primary and secondary packaging used in the pharmaceutical industry. He routinely develops and maintains process control systems related to compounding, freeze-drying, vial filling. Joe also oversees all aspects of design and construction including equipment purchasing and factory testing. Joe is an expert in GMP compliant system design for sterile processes. Joe is also experienced with Hull, Steris, Serail, Usifroid, IMA Edwards freeze dryers and loading systems. Filling equipment: IMA, TL, Bosch, Cozzoli, Bausch & Stroebel, and Chase Logeman.
Anthony Pavell
Principal Consultant
Mr. Anthony M. Pavell is a Principal Consultant with MKCS Inc in Raleigh, NC. Tony has over 14 years of pharmaceutical industry experience. He is currently a pharmaceutical industry consultant focusing on aseptic processing, process and systems validation. He has been involved with the start up/commissioning and validation of four sterile manufacturing facilities. Tony’s experience includes directing production operations, technology transfer of products and processes into the facility, management of all site related validation activities, management of the site calibration program and system assessments using risk management approaches. Tony has held an Operations position with Catalent Pharma Solutions, Technical Services and Validation positions with Cardinal Health, Lloyd’s Register Serentec, Novo Nordisk, Glaxo Wellcome, and Burroughs Wellcome. Tony is a member of the International Society of Pharmaceutical Engineers and the Parenteral Drug Association. Tony received a Master of Science in Molecular Biology and Biotechnology from East Carolina University.
Keith Runyan
Senior Automation Engineer
Keith joined MKCS in December of 1999 to increase the depth of support for ongoing projects, as well as pharmaceutical production operations. Keith has played the lead role in the Automatic Vial Loading and Unloading System Integration with new and existing Freeze Dryers. Keith is responsible for design, installation, testing and maintenance of process control systems in the pharmaceutical and biotechnological industries. Major projects have included compounding, filling, lyophilization, granulation, and coating automation and process support.
Keith has over fifteen years experience with Distributed Control Systems (DCS), Programmable Logic Controllers (PLC), and Supervisory Control and Data Acquisition Systems (SCADA). This experience includes specifying, installing, testing, and programming various aspects of 8 D/3 systems while employed by DuPont, Westinghouse, and MKCS. Keith has worked with Modicon and GE Fanuc PLC systems and the PI process data historian system. Keith holds a BS in Electrical Engineering from the University of South Carolina.
Julius W. “Chuck” Powell, PE
Senior Automation Engineer
Chuck is a Licensed Professional Engineer. He joined MKCS as a senior automation engineer, to support a large-scale customer expansion project. Much of his recent experience has been in Advanced Control/Process Optimization with a focus on continuous processes or batch processes feeding downstream continuous processes. Chuck has spent several years developing platforms for display and analysis of process information. His areas of expertise include system design, hardware specification development, and process development, engineering drawing reviews, software application design, and integration of multiple communication interfaces. Chuck is also familiar with project engineering, managing capital and repair projects, developing cost estimates, preparing bid packages and job scopes, as well as supervising contractors on capital projects.
Chuck is thoroughly familiar with instrumentation and measurement fundamentals and has designed, installed, and commissioned systems in several different industries. He has demonstrated expertise in the measurement and control of flow, level, density, weight, temperature, pressure. He is competent at field instrumentation and final control element application and specification.
Chuck’s recent project experience includes: DSM Dyneema, engineering services providing project engineering support. The project execution involves following all procedures to complete the tasks involved with implementing large and small projects. Chuck will be working with people on the floor in order to ensure success implementation of projects. Assist in performing all HAZOP, safety, and all other studies necessary for project implementation.
Upon Chuck’s transition to MKCS he provided Plant Manager Engineering Support for Universal Leaf North America US, Inc. There he was responsible for installation, commissioning of electrical and automation and process information system development during construction and startup of 1.2 million sq ft plant. Led the development of applications integrating the process database with the quality database. Realized the vision of web-based management information systems. Drove continuous quality improvement efforts using team-based approach and Statistical Process Control. Developed the strategy for automation platforms in key regions worldwide.
Designed, Engineered and Installed the following Project List: -ULNA Nash Facility, -Construction/Startup/Ramp-Up, -Plant Information Systems, -Quality Initiatives, -Worldwide Training Development, -Microwave Moisture Meter Validation.
Chuck holds a degree from University of Florida, Graduated Cum Laude, BS in Electrical Engineering.
Dan Burke
Senior Automation Engineer
Dan has joined MKCS in early 2009 as a Senior Automation Engineer. Dan
brings with him twenty five years pharmaceutical experience with
instrumentation and automation focused on freeze dryers and automated
loading systems. Automation experience includes Allen-Bradley and
Siemens PLCs and Fisher Provox Distributed Controls Systems.
Experience includes installing, troubleshooting, commissioning, and
qualifying freeze dryers and loading systems. Dan has additional
experience assembling OEM industrial machinery including mechanical
assembly, hydraulic and pneumatics, and electrical wiring.
Jeff Wilson
Automation Engineer
Jeff came on board with MKCS in January of 2001 to support an ongoing expansion of a sterile facility and provide support for the automation and validation of existing Freeze Dryers. Jeff has implemented new controls on obsolete control systems for a multitude of lyophilizers. The most recent projects included the removal of an obsolete PC based control system and implementation of an Allen Bradley Control Logix PLC and Wonderware SCADA solution.
Jeff has 10 years of experience in the electric utility industry, at which time he was in charge of design, automation, and control of substations. Jeff's experience with SCADA includes: QEI, Intellution, Wonderware SCADA Systems, Valmet Systems, and Motorola Moscad. Jeff has a B.S. in Electrical Engineering from North Carolina State University.
Reggie Morgan
Automation Engineer
New to our Team, Reggie joined MKCS in January of 2008 as an Automation Engineer, to provide engineering support for new and existing projects. Reggie is a Bachelor of Science in Electrical Engineering; from North Carolina Agricultural & Technical State University. Reggie has strong electrical experience including; designing and creating circuits to integrate with factory systems, electronic circuit analysis, computer skills with extensive knowledge of C++, and Matlab, as well as relevant engineering dynamics in the Automation and Control Fields.
Reggie will be involved with current pharmaceutical projects with the MKCS Team. This includes the direct involvement in implementation of automation solutions to support the production of pharmaceutical products. He is very capable and inventive, and is eager to take on and provide services in all aspects of controls design, develop and documentation efforts.
Will Martin
Senior Automation Specialist
Will was a fresh new addition to our Automation Team in November of 2003; he brings along with him 14 years experience in the manufacturing environment, developing or modifying control systems. Will is also very accomplished in the areas of electrical circuitry, ranging his experience as a Project Management leader of concurrent engineering projects. As of late, Will has lead efforts for automation and validation of a new sterile product facility in Raleigh, NC.
Along with the responsibility of being a Controls Specialist, Will's background in programming and development cycles, incorporates Database Applications including, PLC, Visual Basic, C, HMI / SCADA. Will has a strong sense of the Specifications and Requirements development for HMI / SCADA and Control Processes. Will maintains up-to-date training levels extending in the areas USData's Factory Link HMI Program functions, RSView applications, as well as control program development using Allen-Bradley ControlLogix.
Will is a Biology & Chemistry Major from Pfeiffer College, in Misenheimer, NC. Will continued on his education to pursue and Engineering background from Cleveland State Community College, in Cleveland, TN.
Melanie Quinn
Marketing Executive
Joining the team at MKCS in November of 2000, as Marketing Specialist and Business Office Manager, Melanie is in charge of the progression of new markets, and provides outstanding customer service to established clientele. Recently, Melanie has also provided project management and validation support for a freeze dryer expansion project. Melanie has over 10 years experience in marketing and has studied waste water treatment practices.
Melanie is a graduate of East Carolina University where she received a Bachelor of Arts in Geography, concentrating in Environmental Sciences.
Charles Zadnik
Senior Automation Specialist
Charles comes to MKCS with 30 years manufacturing experience, with heavy involvement in startup in new production, startup from product design, equipment acquisition, training of work force, along with process documentation and process controls. He is knowledgeable in production engineering including effective technical applications, product ideation and concepts for improvement, and customer quality. He has an extensive background working with various Management Levels, including purchasing, product engineering. He has joined MKCS to apply his engineering services, providing project engineering support at DSM Dyneema. The project execution role involves following all procedures to complete the tasks involved with implementing large and small projects. Perform all HAZOP, safety, and all other studies necessary for project implementation. Charles completed 40 hour course in Engineering Management at the University of South Carolina, he also went to the school of Industrial Technology at East Carolina University.
Kyle O’Kane
Project Engineer
Kyle joined MKCS to be a Project Engineer in the field of Automation and Control Systems. He utilizes his mechanical engineering background in all areas of design and modeling components. He has experience from the initial design ideas to the project implementation. Kyle’s abilities and relevant training include but are not limited to; analysis for mechanical engineering design, design of thermal system, dynamics of machines, energy conservation in industry, engineering economics, engineering thermodynamics I, engineering thermodynamics II, fluid mechanics, fundamentals of the ICE, graphic communications, heat transfer fundamentals, and strength of mechanical components. Kyle has a Degree in Mechanical Engineering from North Carolina State University, he holds a spot on the NC State Deans List, as well as has accomplished the Fundamentals of Engineering Exam. He will be supporting our DSM Dyneema Project; Engineering services providing project engineering support. Project execution involves following all procedures to complete the tasks involved with implementing large and small projects.
Work with people on the floor in order to ensure success implementation of projects. Perform all HAZOP, safety, and all other studies necessary for project implementation. Before coming on board with MKCS, Kyle was with The Chassis Group. Here he maintained, designed and modeled mechanical components and assemblies relating to the chassis using Catia
V5 (steering, ground drive, transaxle controls, sheet metal components).
Directly supported production lines. Performed engineering calculations; Stress, Torque, Forces, etc. Planned and developed test programs for product development and cost savings projects using DVP&R. Analyzed test data and results. Prepared, edited, and released detailed part drawings using GD&T and tolerance stacks. Prepared and released illustrated parts manuals for design changes. Standard departmental processes: Bill of Material Changes, Design Failure Modes and Effects Analysis, Engineering Change Notices, Finite Element Analysis, Lean Manufacturing Techniques, Production Approval Process, Root Cause Analysis. Validated and implemented costs savings projects. Worked directly with project management, purchasing, manufacturing, quality, and test personnel to assure safe designs compliant to engineering and industry standards.
Kyle has extensive experience with the following programs; Parametric CAD / Modeling Software, AutoCAD, Lotus Notes, MATLAB, Mathcad, Microsoft Office, -Excel, Word, Power Point, Programming Languages, FORTRAN, Java.
Ann Cherry
Compliance Specialist
Ann joined MKCS in April of 2009 and brings over ten years of experience in
the pharmaceutical industry with a background in sterile injectables, solid
dose, syrups and spray products. Her area of expertise is validation of
sterilization processes, automation, equipment and utilities. Ann's
automation experience includes D/3 DCS, PLCs, RSView SCADA, and HMIs. Her
equipment experience includes autoclaves, freeze dryers, automated
loading/unloading systems, depyrogenation equipment, fillers, tanks, product
delivery systems, unscramblers, labelers and vision systems.
Ann has extensive experience developing, executing and summarizing
validation plans and protocols, has authored standard operating procedures
and equipment operating procedures, and assisted with the development of
technical documents. She has also provided scheduling and project support
services and has established databases. Ann received a BA in English from
the University of North Carolina at Chapel Hill and has done pre-engineering
course work at North Carolina State University.
