2026 ISPE Facility of the Year Awards (FOYA) Category Winner for Operations – Project Execution

Eli Lilly and Company

Location: Concord, North Carolina, USA
Project: Lilly Concord


Eli Lilly and Company’s Concord manufacturing site represents an unprecedented achievement in modern pharmaceutical project delivery. As a fully paperless, automated parenteral manufacturing campus constructed on 415 acres of greenfield land, the facility progressed from groundbreaking in June 2022 to US Food and Drug Administration approval in December 2024—in 30 months, an execution timeline far below industry norms. This acceleration was enabled through disciplined governance, modularization, smart replication of validated design platforms, and deep alignment across operations, engineering, construction, and automation teams.

A central driver of this performance was the Cold Dark Shell implementation approach, which allowed interior fit out activities to advance in parallel with building envelope completion. This strategic overlap condensed traditional sequencing, removing months from the critical path while maintaining compliance and quality boundaries. Five autonomous workstreams—site development, logistics, parenteral operations, device assembly, and administrative/lab spaces—operated with empowered decision making, supported by a unified governance structure that resolved barriers rapidly and ensured alignment with operational readiness milestones.

Smart replication of proven facility and equipment design—from Lilly’s Research Triangle Park site—minimized engineering rework and substantially derisked commissioning. Leveraging pre qualified automation templates, standardized layouts, and harmonized equipment platforms reduced testing durations and enabled the site to reach first device assembly operations three to four months earlier and first syringe filling capability more than a year ahead of comparable deployments.

Modular construction, particularly the offsite fabrication and integration of the 14,000-square-foot central utility plant (CUP), further reduced complexity and improved quality. Delivered as 25 pretested modules, the CUP allowed earlier commissioning of utilities and eliminated typical onsite congestion associated with high density mechanical construction.

Execution was further enhanced by the extensive use of digital twin technology, enabling more than 250 days of virtual testing of automation logic, human-machine interface interactions, and start up sequences before equipment arrival. This innovation cut on floor testing time by roughly half, reduced operational disruption, and ensured a smooth, right first time transition into qualification. All scope was delivered, while maintaining industry leading safety performance.



The Concord project stands as a benchmark for excellence in Operations – Project Execution. Through disciplined governance, replication of proven platforms, aggressive modularization, and digital twin enabled commissioning, Lilly delivered a fully automated, digitally integrated, good manufacturing practice compliant manufacturing campus at industry leading speed. The project establishes a repeatable model for high velocity, high complexity facility delivery and exemplifies the intent of FOYA Category Operations – Project Execution.

Supply Partners and Key Participants:

Manufacturer/Owner: Eli Lilly and Company

Engineer/Architect: Hanbury

Construction Manager: BE&K Building Group

HVAC Subcontractor: McCorvey Sheet Metal

Mechanical Contractor: Kirlin Way

Electrical Contractor: Code Electric, Inc.

Mechanical and Electrical Engineer: HIPP Design & Consulting, Inc.


About the ISPE FOYA Program

Established in 2005, the FOYA program recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches.

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