Pharmaceutical capital projects depend on a relatively small pool of engineering and construction organizations with the expertise to deliver complex, regulated manufacturing facilities. As capital programs compete for experienced personnel, these firms face mounting pressure to meet aggressive schedules, control costs, and coordinate increasingly sophisticated manufacturing systems.
A 2025 interview published by the International Society for Pharmaceutical Engineering (ISPE) highlighted the concentration of pharmaceutical EPC expertise among a limited number of firms. It also identified the challenge of meeting different owner requirements while maintaining consistent project-delivery practices.
This raises an important question for manufacturers and their engineering partners: Should the EPC/EPCM organization continue managing every specialized system in detail, or can more of that responsibility be assigned to qualified suppliers?
The industry already has delivery models that support distributing the workload. The opportunity is to apply them more deliberately.
Facilities of the Future Demand a Different Approach
ISPE's 2025 Facilities of the Future discussions highlighted several developments shaping pharmaceutical capital projects, including standardized facility designs, accelerated construction, off-site prefabrication, and modular systems.
These approaches have implications beyond construction schedules.
Standardized designs allow proven equipment platforms and engineering solutions to be replicated across facilities. Prefabrication moves work from congested jobsites into controlled manufacturing environments. Early supplier involvement allows specialists to contribute to design and integration before construction begins.
Collectively, these practices create opportunities to distribute engineering and execution responsibilities among more organizations.
Instead of relying on the EPC/EPCM team to coordinate every component of a utility system, qualified suppliers can undertake larger, clearly defined portions of the work. The engineering firm retains responsibility for overall facility integration while drawing on specialized capabilities throughout the supply chain.
From Equipment Procurement to System Responsibility
Consider a pharmaceutical water system.
Under a conventional procurement structure, an EPC/EPCM firm may coordinate separate suppliers for pretreatment, purified water generation, Water for Injection (WFI) generation, storage, distribution, instrumentation, and controls.
Each package introduces design interfaces, procurement activities, testing requirements, and documentation that the project team must coordinate.
An integrated approach can assign a more complete scope to a qualified system supplier. Depending on the project, this may include process engineering, equipment integration, automation coordination, factory acceptance testing, commissioning support, and turnover documentation.
The same principle applies to clean steam, high-purity gases, and other specialized manufacturing utilities.
This approach does more than consolidate purchase orders. It places responsibility for defined engineering and execution activities with organizations equipped to perform them.
For resource-constrained EPC/EPCM teams, that distinction matters. A supplier delivering an integrated, verified system can relieve more of the project team's workload than one delivering equipment that still requires extensive engineering and coordination.
Evidence From Pharmaceutical Project Delivery
Major pharmaceutical projects demonstrate how distributed execution can be organized.
At Eli Lilly's Concord, North Carolina, manufacturing campus, a 14,000-square-foot central utility plant was delivered using 25 pretested modules. Recognized in ISPE's 2026 Facility of the Year Awards, the project used off-site fabrication and integration to reduce on-site construction complexity and support earlier utility commissioning.
FUJIFILM Biotechnologies' Holly Springs facility similarly involved hundreds of modular process-equipment skids, requiring coordinated fabrication, testing, delivery, and installation among multiple suppliers.
Engineering firms are also examining alternative delivery practices. CRB has advocated earlier involvement by specialty manufacturers and trade partners to improve constructability and reduce redesign. IPS has discussed changing procurement and contracting arrangements as pharmaceutical manufacturers reassess project costs and engineering deliverables.
These examples demonstrate the industry's use of distributed execution, although they do not establish a universal shift toward complete supplier ownership of utility systems.
Distributing Work Without Losing Accountability
Moving responsibility to suppliers only works when the scope is clearly defined.
An integrated utility supplier may assume responsibility for system design, equipment selection, controls integration, and testing. However, facility connections, cross-system interfaces, installation requirements, and commissioning responsibilities must be assigned explicitly.
Documentation is equally important.
A broader supplier scope requires deliverables that support engineering review, system acceptance, commissioning, and qualification. These may include approved P&IDs, material certifications, automation documentation, test protocols, and turnover records.
ISPE's Baseline Guide Volume 5: Commissioning and Qualification reinforces the value of risk-based verification and appropriate use of supplier-generated documentation.
When requirements and acceptance criteria are established before procurement, suitable supplier documentation can support verification without unnecessary duplication. Without that planning, distributing work may simply create new coordination problems.
The objective is to transfer responsibility for clearly defined work while maintaining effective project oversight.
Rethinking How Capital Projects Are Resourced
Owners and EPC/EPCM firms cannot solve every resource constraint by asking existing teams to manage more work.
Qualified suppliers represent an additional source of specialized engineering and execution capacity. When engaged early and assigned appropriate responsibility, they can undertake substantial portions of system design, integration, testing, and documentation.
For suppliers, this creates an opportunity to expand their role beyond equipment manufacturing. It also raises expectations for engineering competence, organizational capacity, and accountability.
For owners and EPC/EPCM firms, the decision is which systems can be delegated without compromising facility integration, project control, or regulatory requirements.
The next improvement in pharmaceutical capital-project delivery may come from distributing work more intelligently, rather than concentrating additional responsibilities within the same engineering organizations.
As ISPE's Facilities of the Future discussions illustrate, the technical approaches needed to support this transition are already established. The challenge is defining responsibilities early enough for owners, engineering firms, and suppliers to execute them effectively.
Hygenix helps pharmaceutical manufacturers, EPC/EPCM firms, and technical suppliers establish project requirements, system boundaries, and documentation responsibilities that support this delivery approach.
Contact Hygenix to discuss how clearer requirements and supplier scopes can support your next capital project.