Meet the 2025 ISPE Facility of the Year Awards (FOYA) Category Winner for Operations, Project Execution: Johnson & Johnson Innovative Medicine – Ireland

This project is recognized as the 2025 FOYA category winner in Operations – Project Execution due to the following reasons:

1. Safety adherence with a low recordable incident rate (TRIR) and drug-associated risk tool (DART) performance
2. Complexity factor with the expansion conducted while the existing plant continued to operate
3. Integrated teams with Johnson & Johnson working closely with their partners
4. Innovation and process intelligence with the use of new technology and operations strategies to improve operational and project performance
5. Social impact with a focus on sustainability and its impact on the local community, as part of Johnson & Johnson’s credo

The project had five clear objectives which were accomplished:

1. Committed to getting everyone home safely every day, the project had 2,600,000 safe man hours
2. In compliance with environmental, health, and safety and quality standards, the team managed over 1,100 safety audits and successful regulatory inspections
3. No disruption to current production with no unplanned manufacturing downtime
4. A fully integrated approach with the current manufacturing site; 80 batches were successfully manufactured and released during the project’s timespan
5. Completion within budget and on schedule: the project was completed under budget and 11 months ahead of schedule

This large capital expansion had a large complexity factor as the team constructed this facility within a live plant, which entailed navigating complex challenges to achieve seamless integration and no manufacturing disruption. This required innovative risk management strategies to proactively identify and mitigate potential hazards to ongoing operations. A clear team structure was vital for effective communication and coordination among stakeholders while interfacing with existing site activities.

The project complexity necessitated exceptional interdependent collaboration, leading them to implement innovative strategies for the safe and efficient delivery of quality products and services. At its peak, the project had over 850 personnel on site supporting the expansion. A multifunctional team oversaw all phases from concept to operations. Project interface leads played a crucial role in coordinating construction activities with manufacturing operations while maintaining safety and compliance.

Johnson & Johnson established a safety culture that encouraged a proactive reporting of safety observations based on a “see something, say something, do something” philosophy. This commitment to safety as a core value in the delivery of this project delivered an impressive safety performance with a TRIR of 0.075, and DART of 0.075.

From a social impact point of view, the project achieved a LEED Silver Certification for the manufacturing expansion areas. The project will save ~3000 m3 of water each year and over three tons of disposable materials.

In terms of innovation, the teams used the following strategies to improve project performance via use of drone and virtuality reality for collaborative decision making. The engineering and construction process used a digitally enabled strategy from commissioning through operational readiness where all documentations with digitally and totally paperless.

Based on these innovative ways of working and implementing this project in a safe and sustainable manner, Johnson & Johnson Innovative Medicine is recognized as the 2025 ISPE FOYA category winner for Operations – Project Execution.

Supply Partners and Key Participants

Manufacturer/Owner Name: Johnson & Johnson Innovative Medicines Ireland

Engineer/Architect: PM Group, Cork Office

Construction Manager: PM Group, Cork Office

Commissioning: PM Group, Cork Office

CSA: John Sisk & Sons, Cork Office

Piping Subcontractor: Radley Engineering Limited

Electrical Subcontractor: STS

Automation and Control Supplier: Cognizant, Cork Office

About the Operations Category

Winners in this category exemplify the application of novel tools and approaches to delivering projects that improved efficiencies, overcame unusual challenges, promoted effectiveness, and organized stakeholders and project team participants in ways that led to successful outcomes such as efficiency, delivery, quality, product yield, consistency, and cost of goods. Projects demonstrate a culture of continuous improvement behaviors which yielded superior results. Additionally, these principles, systems and tools ensure business continuity through a stable supply environment, health and safety, and customer satisfaction from existing or new facilities, processes, and manufacturing operations.>