David M. Marks, P.E. – President
David founded DME in 2001 to help advanced technology research and manufacturing companies reach their business goals through innovative design solutions. Clients frequently come to DME when they need technically complex facility expansions or renovations, or when they are interested in improving the reliability, efficiency, and regulatory compliance of cGMP manufacturing operations.
As a principal of the firm, David’s role includes business development and engineering/consulting to support global projects in life sciences and other high purity chemical process industries. He is a subject matter expert, speaker, and author in several areas, including bioprocess systems and cGMP-compliant facilities. He is an active member of the ASME Bioprocess Equipment (BPE) standard committee, and serves as chairman of the systems design subcommittee. A graduate of Lafayette College, David holds a BS in Chemical Engineering and is a registered Professional Engineer.
“I’m passionate about developing a best in class organization that enhances the fabric of our lives by enabling the success of our clients. While not at work, I enjoy time with family and outdoor activities.”
Stephen Kohlbrenner – Vice President of Engineering
When Steve joined DME in 2003 to lead global projects, he brought a vast background in pharmaceutical process development, project management and facilities engineering. As VP of Engineering, he oversees day-to-day operations, providing engineering support in the life sciences, food and high purity chemical process industries.
Prior to joining DME, Steve worked for several large pharmaceutical companies in the roles of Facilities Maintenance Manager, Engineering, and Process Engineering Manager, giving him a keen understanding individual client needs. One of Steve’s many strengths is relating to and understanding the expectations of the client PM in charge of the project—and as a result, becoming a trusted ally throughout the entire process.
Steve earned a Bachelor of Science in Chemical Engineering from Widener University. He is a member of ISPE, DBIA and BPSA.
“I enjoy working with clients to establish clear project goals and user requirements then crafting a deliverable tailored for their specific industry. By customizing the level of detail and complexity of the design package, it is possible to accomplish project goals, meet all regulatory requirements, and provide the best value for the client.”
Edward Caulkins, P.E. – Director of Facilities Engineering
As Director of Facilities Engineering, Ed leads a talented team of MEP engineers in the implementation of advanced technology projects. His expertise is in HVAC systems for cleanrooms and process areas, central and process utilities, plumbing and fire protection systems design.
Ed refined his craft by pulling from thirty years of experience within the regulated life sciences and semiconductor industries. He leans on this core competency to extract the most of his team. Ed’s philosophy is to approach each project uniquely and strive to build a solution based on the client’s individual needs.
Ed is a member of ASHRAE, ISPE, and NFPA. He earned a Bachelor’s Degree in Architectural Engineering/Mechanical Systems from Pennsylvania State University and is a registered Professional Engineer in Pennsylvania, Maryland and New Jersey.
“Our goal at DME is to provide a quality and value added solution to our clients’ needs. We do not use a ‘cookie cutter’ approach, as we believe all projects have independent and specific requirements. While we borrow from our experience, we do not apply a one size fits all design.”
Hite Baker – Principal Process Engineer
An industry innovator in cGMP manufacturing, Hite’s focus is equipment and facility design for parenteral fill-finish operations. He has extensive experience in the regulated life sciences industry, including biopharmaceuticals, vaccine products, cleanroom facility design, and technology transfers. An expert in sterile manufacturing technology, Hite has led engineering design efforts for every stage of the process—from formulation to sterile filling to lyophilization —as well as for the isolation technology and cGMP facilities where drug products are manufactured.
Hite holds dual degrees in Mechanical and Electrical Engineering from Virginia Polytechnic Institute and State University. He is an active member of ISPE and is a member of the SPP COP Steering Committee where he co-leads their barrier education track.
“I help clients reach their project goals…on time, within budget. Remarkably, most clients have the same overall goal. I help clients focus on their facility engineering issues and provide cost effective solutions, which make best use of available modern technologies—ultimately ensuring that products of the highest quality are consistently manufactured.”
William (Bill) Fitch, P.E. – Senior Electrical Engineer
Bill began his electrical engineering career in the nuclear power industry, where he received exceptional training and acquired a disciplined approach to his craft. He spent the next twenty years gaining proficiencies in detailed design, component and field engineering, project leadership, and technical oversight, before joining DME. Bill enables clients to maximize the capability, reliability, capacity, and infrastructure of their facilities. His project portfolio includes research laboratories, animal housing and care, manufacturing facilities, critical facilities, and substation design.
Bill earned a BS in Electrical Engineering from Drexel University and is a registered Professional Engineer in nine states. He is a member of NCEES and a senior member of IEEE, participating in the Industry Applications and Power & Energy Societies.
Timothy (Tim) J. Hancock, Ph.D. – Senior Process Engineer
As a Senior Process Engineer with twenty years of experience, Tim leads projects for DME clients in the areas of process design, equipment selection and specification, cGMP manufacturing support, equipment commissioning and verification, and technical analysis. His bioprocess experience includes microbial fermentation, mammalian cell culture, vaccine manufacturing, process automation, and biohazard containment.
Tim holds an undergraduate degree in Chemical Engineering from the University of Waterloo and a Ph.D. in Biochemical Engineering from Lehigh University. Tim is a member of ISPE, ACS, and the Chemical Institute of Canada. In July 2014, he presented on the topic Batch Versus Continuous Processing at the Facility Design, Innovation and Qualification’s Validation/Manufacturing (IVT) conference.
“I feel it is a privilege to help solve issues and provide solutions for our clients in the vaccine and therapeutics manufacturing world. It provides a real sense of purpose to know that our efforts help heal and cure those outside of our company.”
Randy Nelson – Lead Process/Mechanical Engineer
Randy is a Process/Mechanical engineer with experience in the specification, design, fabrication, commissioning, and qualification of custom pilot and production-scale process systems. His background in cGMP equipment design and development has been leveraged in aseptic process systems including fermentation, cell culture, buffer prep, filtration, sterilization, biowaste inactivation, formulation, filling, and packaging systems. Randy’s experience also includes detailed design and implementation of Clean-In-Place and Steam-In-Place systems, as well as single-use process technology.
Randy earned a BS in Mechanical Engineering from University of Minnesota Institute of Technology and an AS in Automation Technology from Northeast Metro Technical College. He is a member of ASME and ISPE.
“There is great satisfaction in designing an efficient system that meets the unique needs of our clients. The most rewarding time in a project life cycle is during startup, when the team’s efforts culminate into a fully functioning system. My personal goal is to bring projects in on time and within, or under budget.”
Victoria Perity – Senior Project Engineer
Victoria has over twelve years of experience with bioprocess design, equipment engineering and commissioning, and QA/validation projects for the food and pharmaceutical industries. As an experienced project manager, she brings organizational strength when coordinating resources, schedules and budgets for multiple concurrent projects. Victoria has participated in design, operation, troubleshooting, and validation of custom bioprocessing systems.
Victoria has a Bachelor of Engineering degree from McMaster University and is a member of ISPE. In her personal life, Victoria carries the same level of passion as an avid kayaker and stand up paddleboard instructor.
“I love my job at DME because I am given so much flexibility with my clients. I pride myself in pushing boundaries, while helping clients make meaningful decisions—and enjoy the fact that my purpose is to make things happen for the client’s benefit.”
Andrew Ricker, P.E. – Senior Mechanical Engineer
A senior MEP engineer at DME, Andy has twenty years of engineering, project management, and design experience. He excels in HVAC design, central utility and plumbing systems.
Great design, especially when working in legacy facilities, often comes from altering, or improving what is already there, rather than creating something completely new. Andy is exceptionally adept at sizing up existing facility conditions and identifying the best engineering solutions to achieve the owner’s goals.
Andrew is LEED Green certified, a NSPE member, and a registered professional engineer in PA, NJ and NC. He is a graduate of the Pennsylvania State University where he earned a BS in Mechanical Engineering Technology.
“In this economy, you can’t risk losing business because you aren’t able to handle change. To adapt, I use my project experience, and that of my team members, to adjust the execution plan in response to necessary changes. Each project presents its own set of challenges; something always comes up. The way we respond creates the difference.”
Eric Sipe – Senior Process Engineer
As a Senior Process Engineer at DME, Eric’s background working for some of the leading biopharmaceutical manufacturers is a real asset —bringing 30 years of experience in engineering and project management. Eric’s engineering focus and expertise cover a broad range of process equipment, process instrumentation, and unit operations. He leads some of DME’s most technical projects involving small molecule APIs, Biotechnology, Parenterals, Chemical Process Unit Operations, and Clean Utilities.
Eric earned a degree in Chemical Engineering from Pennsylvania State University, and holds Certifications as an Engineer in Training (EIT) and Project Management Professional (PMP). An avid writer and speaker, Eric assisted in authoring chapters in Good Design Practices for cGMP Pharmaceutical Facilities and ISPE Baseline Guide for APIs.
“In addition to working with great people around the globe, DME gives me the opportunity to do what I love most—learning how things in everyday life are made, through the eyes of an engineer. Through my work, I honestly feel that I have a part in enriching people’s lives.”
Lynn Zeiner – Business Manager
Lynn is DME’s business manager responsible for all commercial operations, finance, HR, and contract administration. As one of the company’s first employees, Lynn is quite knowledgeable about the firm. She is involved with front line client contact, proposal preparation, contract negotiations, and most financial areas. While responsible for many functions, Lynn also pays attention to every detail. She has played a critical role in developing the company’s business plan, as well as all of the systems that support DME’s expansion.
Lynn is typically the first person that job candidates meet. She also administers all of the company’s philanthropic initiatives. Personally, Lynn is very active in the community as a fundraiser, volunteer, and coordinator for multiple organizations and charities.
“I thrive on leveraging my extensive HR experience, along with a life-long passion for personal development and learning. To improve the efficiency and success of the firm, I never shy away from taking on new challenges.”