2025 ISPE FOYA Category Winner for Operations – Project Execution | ISPE | International Society for Pharmaceutical Engineering

Johnson & Johnson Innovative Medicine

Location: Ringaskiddy, Cork, Ireland
Project: BioCork 3.2 Expansion Project

This expansion of a Johnson & Johnson Innovative Medicine plant in Ringaskiddy, Cork, Ireland increased the existing biomanufacturing capacity at the plant while also creating employment for 180 people in the local community. This manufacturing project delivered cutting-edge healthcare solutions using innovative technology with flawless execution and is a key part of the Johnson & Johnson global supply chain.

This project is awarded Facility of the Year Award category winner recognition due to the following reasons:

Safety adherence with a low recordable incident rate (TRIR) and drug-associated risk tool (DART) performance
Complexity factor with the expansion conducted while the existing plant continued to operate
Integrated teams with Johnson & Johnson working closely with their partners
Innovation and process intelligence with the use of new technology and operations strategies to improve operational and project performance
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:

Committed to getting everyone home safely every day, the project had 2,600,000 safe manhours
In compliance with EHS&S and quality standards, the team managed over 1,100 safety audits and successful regulatory inspections
No disruption to current production with no unplanned manufacturing downtime
A fully integrated approach with the current manufacturing site; 80 batches were successfully manufactured and released during the project’s timespan
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 and required 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 required exceptional interdependent collaboration, leading them to implement innovative strategies for the safe and efficient delivery of quality products and services. At 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.

On BC3.2 safety culture encouraged a proactive reporting of safety observations based on “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