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FDA Compliant Design & Regulatory Services

Hixson helps regulated manufacturers plan and design facilities, processes, and systems that align with FDA expectations from early definition through implementation. With 75+ years of architecture and engineering experience, our integrated team supports compliant, efficient environments for food, beverage, pharma, biotech, and other GMP operations across North America.

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Our FDA Compliant Design & Regulatory Services

Integrated design, engineering, and compliance support for regulated facilities, processes, and operational environments.

Pharma & Biotech

Design support for cGMP pharmaceutical and biotech spaces, helping clients define requirements, coordinate disciplines, and create compliant environments from URS development through detailed design.

Process Engineering

Process and manufacturing engineering for regulated operations, including flow development, equipment layouts, P&IDs, HAZOP review, utility requirements, and startup support for FDA-sensitive environments.

Controls Automation

Controls and automation engineering that supports validated, reliable operations through system design, programming, testing, commissioning, and integration for GMP and FDA-regulated manufacturing facilities.

EH&S Compliance

Environmental, health, and safety compliance support integrated into facility planning and design to help regulated projects address permitting, risk reduction, and operational readiness.

Lab Design

Laboratory design solutions that balance technical performance, workflow, safety, and user needs while supporting regulated science and technology environments with integrated planning expertise.

Strategic Consulting

Upfront facility and project consulting that helps organizations align business goals, compliance requirements, and long-term operational needs before major capital decisions are made.

Regulated facility design process meeting

Our FDA Design Process

Define Requirements and Risks

We begin by understanding your product, process, regulatory obligations, and operational goals. This includes gathering user requirements, identifying GMP considerations, and clarifying the compliance risks that should shape design decisions from the start.

Plan the Facility Strategy

Develop Integrated Design Documents

Support Procurement and Validation Readiness

Guide Startup and Operational Handover

Trusted By Industry

Success Stories

See how Hixson supports complex regulated projects for leading manufacturers and science-driven organizations.

"Love it."

Zachary Waas
Zachary Waas
The Hixson Difference

Why Choose Hixson?

Clients rely on Hixson for integrated expertise, long-term perspective, and disciplined project execution.

Integrated Team

Twenty in-house disciplines streamline coordination across architecture, engineering, process, and compliance-focused project needs.

Deep Experience

Since 1948, Hixson has built specialized expertise for regulated food, science, and GMP environments.

Risk Reduction

Proven project management methods help reduce project risk and improve execution quality across complex facilities.

Trusted Culture

Great Place to Work certified with strong associate tenure that supports continuity throughout long projects.

Meet The Hixson Team

Experienced specialists guiding regulated projects with integrated expertise.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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 does FDA compliant design mean for a facility project?

FDA compliant design means planning the facility, process flow, utilities, materials, and operational spaces in ways that support regulatory expectations for safety, quality, cleanliness, documentation, and control. It typically includes attention to cGMP principles, sanitary design, segregation, cleanability, workflow, and equipment integration so the finished environment is better prepared for regulated production and inspection.

What industries benefit from FDA compliant design and regulatory services?

Can Hixson support both facility design and regulatory-focused engineering?

Does Hixson work on cGMP projects?

When should regulatory design support begin in a project?

Can you help with automation and controls in regulated environments?

How do FDA compliant design services help reduce project risk?

Does Hixson serve clients outside its headquarters region?

Still Have Compliance Questions?

Talk with Hixson about your regulated facility goals.

Certified & Trusted

Awards and Recognition

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Great Place to Work

Certified workplace culture and team stability.

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Rising Giant Ranking

Recognized by Interior Design magazine.

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Sector Recognition

Top firm recognition across core sectors.

Plan Your FDA-Compliant Project With Confidence

Share your facility, process, or regulatory goals and Hixson's team will help outline the right next steps 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.