cGMP Facility Design
Design and engineering for oral solid dose, sterile processing, biologics, vaccines, clean utilities, controlled environments, HVAC, pressurization, and documentation supporting IQ, OQ, and PQ validation activities.
Hixson delivers integrated cleanroom engineering for GMP facilities that must perform reliably, meet regulatory expectations, and support future growth. From URS definition and cleanroom classification planning to HVAC, utilities, process integration, and validation-ready documentation, Hixson helps pharmaceutical, biotech, biologics, and cell and gene therapy teams reduce risk from concept through construction administration.

Integrated cleanroom, cGMP, process, utility, and automation design for regulated pharmaceutical and biotech manufacturing environments.
Design and engineering for oral solid dose, sterile processing, biologics, vaccines, clean utilities, controlled environments, HVAC, pressurization, and documentation supporting IQ, OQ, and PQ validation activities.
Cleanroom engineering for sterile fill/finish, vialing, prefilled syringes, ophthalmics, isolators, RABS, ISO Class 5 critical zones, unidirectional airflow, and Annex 1-aligned aseptic manufacturing operations.
Engineering for pre-engineered cleanroom modules, skid-mounted process units, and modular cGMP fit-outs that improve speed-to-market, regulatory predictability, and future capacity flexibility.
cGMP cleanroom design for viral vectors, autologous and allogeneic cell therapy, plasmid DNA, CRISPR, CAR-T manufacturing, BSL-2 containment, single-use equipment, and clean utilities.
Engineering for upstream bioreactor suites, downstream purification, chromatography, UF/DF, lyophilization, fill/finish, biosafety containment, cleanroom HVAC, pressurization, and FDA, EMA, and PIC/S documentation needs.
Integrated mechanical, electrical, plumbing, fire protection, structural, and civil engineering for GMP facilities, including HVAC, process piping, electrical distribution, utilities, and infrastructure supporting regulated manufacturing.

Hixson begins by aligning with client stakeholders on the URS, product pipeline, regulatory expectations, cleanroom classifications, capacity targets, process flows, and business objectives that will guide every design decision.
Hixson supports complex regulated facilities for recognized food, pharmaceutical, biotech, laboratory, and manufacturing organizations.
Hixson brings integrated technical depth to complex GMP cleanroom projects.
Founded in 1948, Hixson brings decades of regulated facility design experience.
Twenty in-house technical disciplines coordinate cleanroom, process, utility, and building systems.
Teams understand cGMP, FDA, EU GMP Annex 1, PIC/S, and validation documentation needs.
Specialized project management and engineering methods reduce risk in complex regulated environments.
Experienced leaders support integrated GMP facility delivery.

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.
Cleanroom engineering services for GMP facilities include the planning, design, and coordination of controlled environments used in regulated manufacturing. This typically covers cleanroom classification, HVAC and pressurization, personnel and material flows, clean utilities, process integration, finishes, automation, commissioning support, and documentation that supports validation activities such as IQ, OQ, and PQ.
Talk with Hixson about your GMP facility requirements.
Certified culture supporting long-term technical talent.
Ranked No. 178 by Interior Design magazine.
Recognized across core industry sectors.
Share your facility goals, production requirements, and regulatory drivers. Hixson’s team can help define the right engineering path for your cleanroom project.
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.