Google Icon

Expert Biological Process Development Facility Design & Engineering

Hixson helps biotech and pharmaceutical teams translate complex biological processes into compliant, efficient facilities built for development, scale-up, and future manufacturing readiness. With 75+ years of architecture and engineering experience, 20 integrated in-house disciplines, and deep cGMP expertise, Hixson supports critical decisions around cleanrooms, utilities, workflows, automation, containment, and validation-ready documentation.

Biotech process development facility cleanroom

Our Biological Process Development Services

Integrated planning, architecture, engineering, and compliance support for biotech process development and cGMP environments.

Biologics Design

Facility design for mAbs, vaccines, recombinant proteins, blood products, and biosimilars, including upstream suites, downstream purification, fill/finish, cleanroom HVAC, containment, clean utilities, and validation-supporting documentation.

Pharma Biotech

cGMP space planning and engineering for oral solid dose, biologics, vaccines, controlled environments, clean utilities, HVAC pressurization, compliant finishes, and documentation supporting IQ/OQ/PQ validation strategies.

Cell Gene Therapy

Design and engineering for viral vector, autologous and allogeneic cell therapy, plasmid DNA, CRISPR, and CAR-T facilities with ISO cleanrooms, containment, single-use integration, and clean utilities.

Aseptic Processing

cGMP design for sterile fill/finish, aseptic vialing, prefilled syringes, ophthalmics, and biologics using ISO Class 5 zones, RABS, isolators, unidirectional HVAC, and Annex 1 alignment.

Modular cGMP

Design for pre-engineered cleanroom modules, skid-mounted process units, and modular fit-outs that support speed-to-market, regulatory predictability, and flexible capacity for CMO/CDMO and biotech clients.

Master Planning

Long-range pharma and biotech planning for cGMP zones, cleanroom expansion, clean utility infrastructure, warehouse and material flow, QA/QC labs, and phased capital deployment tied to pipeline milestones.

Engineering team reviewing biotech facility plans

Our Facility Design Process

Define Process and User Requirements

Hixson begins by aligning with your process, product pipeline, URS, capacity goals, biosafety needs, and regulatory expectations. This establishes the technical basis for layouts, utilities, containment, workflows, and future expansion decisions.

Plan Flows, Zones, and Infrastructure

Engineer Integrated Facility Systems

Document, Support, and Commission

Trusted By Leaders

Proven Project Experience

Hixson supports complex facility programs for recognized food, beverage, pharma, biotech, and science clients.

"Very cool place with nice employees."

RaiderGreg
RaiderGreg

"Love it."

Zachary Waas
Zachary Waas

"Great Group of people. Thank You for supporting Special Olympics!"

Rebekah Travis
Rebekah Travis

"Very cool place with nice employees."

RaiderGreg
RaiderGreg

"Love it."

Zachary Waas
Zachary Waas

"Great Group of people. Thank You for supporting Special Olympics!"

Rebekah Travis
Rebekah Travis

"Very cool place with nice employees."

RaiderGreg
RaiderGreg

"Love it."

Zachary Waas
Zachary Waas

"Great Group of people. Thank You for supporting Special Olympics!"

Rebekah Travis
Rebekah Travis
The Hixson Difference

Why Choose Hixson?

Hixson brings integrated technical depth to complex process development facility projects.

75+ Years

Founded in 1948, Hixson brings decades of facility design and engineering perspective.

Integrated Disciplines

Twenty in-house technical disciplines coordinate architecture, engineering, controls, utilities, and project delivery.

cGMP Expertise

Teams design controlled environments with FDA, EMA, PIC/S, and validation needs in mind.

Client Partnership

Strategic teams serve as an extension of client organizations, reducing risk and improving outcomes.

Meet Hixson’s Engineering Leaders

Experienced discipline leaders guide complex facility programs.

John Brockmeier P.E. professional headshot

John Brockmeier P.E.

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.

Craig Cheevers professional headshot

Craig Cheevers

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.

Warren Green P.E. professional headshot

Warren Green, P.E.

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.

Steve Guyer P.E. professional headshot

Steve Guyer, P.E.

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.

Chris Jarc professional headshot

Chris Jarc, P.E., PMP, LEED AP

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.

Dave Klenk professional headshot

Dave Klenk

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.

Kyle McAllister professional headshot

Kyle McAllister

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.

Scott McGlamery P.E. professional headshot

Scott McGlamery, P.E.

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.

Scott Wever professional headshot

Scott Wever

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.

Derek Wojcikowski professional headshot

Derek Wojcikowski

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.

Frequently Asked Questions

What is included in Biological Process Development Facility Design & Engineering?

It typically includes process and facility planning, cGMP zoning, cleanroom layouts, personnel and material flows, clean utility systems, HVAC pressurization, process piping, automation, safety reviews, and documentation supporting validation. Hixson integrates architecture, engineering, controls, and project delivery disciplines to help clients move from early requirements through construction administration and commissioning support.

How early should Hixson be involved in a process development facility project?

Can Hixson design facilities for biologics and cell therapy programs?

Does Hixson support clean utilities and controlled environments?

Can Hixson help with modular cGMP facility strategies?

How does Hixson address compliance during facility design?

Does Hixson provide automation and commissioning support?

What makes Hixson different from a general architecture firm?

Still Have Facility Questions?

Connect with Hixson’s team to discuss your project goals.

Certified & Recognized

Awards and Recognition

Great Place to Work certification logo

Great Place to Work

Certified workplace culture and associate experience recognition.

Interior Design Rising Giants recognition logo

Rising Giants

Ranked No. 178 by Interior Design magazine.

Top sector firm recognition logo

Top Sector Firm

Recognized in core architecture and engineering sectors.

Plan a Smarter Biotech Facility

Tell Hixson about your process, pipeline, compliance needs, and facility goals. The team can help clarify next steps, technical requirements, and the right planning path for your project.

Contact Us Today

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.