cGMP Master Planning
Plan future-state cGMP zones, cleanroom expansion, QA/QC labs, warehouse flows, and phased capital deployment aligned with pipeline progression, regulatory milestones, and manufacturing growth.
Hixson helps gene therapy manufacturers plan scalable, compliant facilities that support today’s pipeline and tomorrow’s growth. From cGMP zoning and cleanroom expansion to clean utilities, material flow, and phased capital deployment, our integrated architecture and engineering teams create practical master plans that reduce risk, improve decision-making, and align facility investments with regulatory and operational milestones.

Integrated planning, design, engineering, and consulting for scalable cGMP gene therapy facilities.
Plan future-state cGMP zones, cleanroom expansion, QA/QC labs, warehouse flows, and phased capital deployment aligned with pipeline progression, regulatory milestones, and manufacturing growth.
Develop facility strategies for viral vector production, plasmid DNA, CRISPR, CAR-T, autologous, and allogeneic platforms with ISO cleanrooms, containment, and single-use integration.
Evaluate modular cleanroom modules, skid-mounted process units, and tenant fit-outs to improve speed-to-market, capacity flexibility, and regulatory predictability.
Plan WFI, USP purified water, clean steam, pure gases, HVAC, pressurization, and building utilities sized for current operations and future facility expansion.
Assess capital portfolios, capacity utilization, operational efficiency, facility benchmarking, and growth scenarios to guide confident investment decisions before design begins.
Integrate FDA-aware cGMP planning, BSL-2 containment, waste management, EH&S considerations, and documentation strategies that support validation and compliance readiness.

We begin by aligning stakeholders around therapeutic platforms, production volumes, pipeline timing, regulatory expectations, and business goals so the master plan reflects both scientific needs and capital priorities.
Hixson supports complex facility programs for leading pharma, biotech, science, and manufacturing organizations.
Hixson brings integrated expertise, disciplined planning, and deep technical knowledge to complex cGMP facility decisions.
Decades of architecture and engineering experience inform practical, risk-aware facility planning decisions.
Twenty in-house technical disciplines collaborate daily to align process, building, and utility requirements.
Specialized pharma, biotech, and cleanroom knowledge supports compliance-minded planning from the start.
Capital phasing, capacity modeling, and operational priorities help clients invest with confidence.
Experienced leaders guide complex architecture and engineering decisions.

Manager, Plumbing Systems & Fire Protection Engineering
John oversees the department responsible for the design and engineering of plumbing systems and fire protection engineering for a variety of project types, including new construction, building utility upgrades, utility capacity analyses, and process line additions. John and his team work with a range of systems, including domestic water, process water, hot water production, direct contact water heaters, high pressure/rinse water, compressed air, natural gas, sanitary drainage, process drainage, central sanitation systems, fire pumps, and fire sprinkler systems.

Manager, Controls & Automation Engineering
As the Manager of Hixson's Controls & Automation department, Craig guides the team responsible for designing, implementing, and commissioning advanced control systems and automation solutions. His responsibilities include overseeing the development of automation strategies that streamline manufacturing processes, enhance operational efficiency, and ensure seamless integration of new and existing systems.

Manager, Process Engineering
Warren leads the team providing processing design services, process optimization studies, and process commissioning and FAT, SAT, and IQ activities. He advises on waste, energy, and GHG emissions reductions, and conducts safety and dust evaluations, including PSM/HAZOP. His expertise spans all food and beverage sectors including fluid, dried and cultured dairy products, processed meat, flavors, and prepared foods. Warren is also on the IDFA Food Safety Committee and actively participates in the 3A, SSI steering committee, and work groups.

Manager, Civil Engineering
In his role as Manager of Civil Engineering, Steve leads the team responsible for the planning, design, and engineering of roads, stormwater hydraulics and modeling, and onsite utilities. On project work, Steve is responsible for civil site project design, specifications, technical design, and project coordination with the client, government regulatory bodies, outside consultants, and contractors. As a senior staff member with our firm, Steve also serves as a mentor to newer associates.

Vice President & Director, Project Management Services
Chris, a Hixson officer and member of the Board of Directors, oversees Hixson’s Project Management, Cost Estimating, and Construction Administration departments. Chris also serves in a project management role, leading teams consisting of representatives from the client, Hixson, contractors, and vendors to effective project completion. Chris assumes overall responsibility for development of project delivery strategies, coordination of all Hixson disciplines, and facilitating effective communication and management to focus resources on delivering high-quality projects on time and within budget.

Manager, Mechanical Engineering
Dave brings more than three decades of experience to his role as the Manager of Hixson’s Mechanical Engineering Department. His work has included the design and project management of new facilities, as well as modification of existing facilities for high technology and food processing industries. At a corporate level, Dave is a member of Hixson’s Dairy and Beverage Industry team, which works to continuously improve the value Hixson offers to the dairy industry through development of our knowledge base, services and capabilities.

Manager, Electrical Engineering
Kyle serves as the Manager of Hixson’s Electrical Engineering department. In this role, he oversees the team responsible for the creation and delivery of electrical designs. This includes the design of high, medium, and low voltage power distribution, lighting, telecommunications, and fire alarm systems. Kyle brings more than 15 years of experience in electrical consulting and design to his role. Areas in which Kyle specializes include electrically hazardous area classification, high- and medium-voltage power distribution, protective relaying, arc flash studies, harmonics analysis, cogeneration design, emergency systems design, and complex laboratory designs.

Senior Vice President, and Director, Mechanical & Electrical Engineering
Scott, an officer of the firm, leads the teams responsible for mechanical and electrical project tasks and design, specifications, technical content, consultation during equipment selection and installation and systems start-up assistance. In addition, Scott also serves as the Quality Assurance Manager, overseeing the firm’s commitment to quality. Over Scott’s more than three decades of experience, he has worked on greenfield, brownfield, and renovation projects for food & beverage plants in all sectors, labs, pharma & biotech facilities, and workplace projects.

Manager, Manufacturing Engineering
In his role as Manager of Hixson’s Manufacturing Engineering department, Scott leads the team responsible for project consulting and coordination between client, vendor, and internal disciplines within Hixson for overall manufacturing processes, functionality, equipment, and layouts. These team members develop process flow diagrams, equipment lists, and preliminary utility requirements, as well as develop equipment layouts that range from high level master planning to detailed construction documents. In addition to this role, Scott is a member of Hixson’s Meat Industry advisory team, focusing on technologies related to the meat and plant protein industry.

Director of Architecture
Derek is the Director of Hixson’s Architecture department. In this role, Derek leads the teams who design projects for our Food & Beverage, Pharma & Biotech, Laboratory, and Workplace clients. Previously, Derek served as the Manager of Hixson’s Process Layout department, where he directed the team that plays a critical coordination role in the overall development of process models and the 3D equipment model management process. Prior to these management roles, Derek, who began his career with Hixson in 2008, served as a Project Architect.
Gene therapy facility master planning defines the long-term physical, operational, and capital roadmap for a cGMP manufacturing facility or campus. It addresses cleanroom classifications, material and personnel flows, utility infrastructure, containment, labs, warehousing, expansion zones, and phasing. The goal is to help organizations make facility decisions that support current production needs while preserving flexibility for future platforms and capacity.
Talk with Hixson about your facility goals and constraints.
Certified workplace culture and associate engagement.
Ranked No. 178 by Interior Design magazine.
Recognized in key architecture and engineering sectors.
Share your pipeline, capacity, and facility goals with Hixson. Our team will help you define the right planning path, key considerations, and next steps.
For immediate assistance, feel free to give us a direct call at +1 513-241-1230. You can also send us a quick email at info@hixson-inc.com.
For immediate assistance, feel free to give us a direct call at +1 513-241-1230. You can also send us a quick email at info@hixson-inc.com.