A dedicated €150M greenfield Active Pharmaceutical Ingredient manufacturing plant — where the core components of life-saving medicines are produced. Designed by Jacobs Engineering and delivered with a comprehensive 36-month lean construction programme by Lean Touch Solutions.
Last Planner® System
Value Stream Mapping
A3 Problem Solving
6S Methodology
Lean Behaviours
Unlike expansion or live-site projects, the Ballydine API facility was a pure greenfield construction — a blank site transformed into a dedicated, fully GMP-compliant Active Pharmaceutical Ingredient manufacturing plant. This meant total design freedom, but also total design complexity: every system, every service connection, every environmental classification zone, and every validation protocol had to be engineered and constructed from scratch. The lean construction programme was designed to manage this complexity from day one — not as a remedy, but as the operating system of the entire 36-month delivery.
| Project Value | Duration | Teams Collaborated with | Systems Installed & Comissioned | Partners Trained & Certified |
|---|---|---|---|---|
| € 150M | 36 Months | 10 | 176 | 60 |
| Project Value | € 150M |
|---|---|
| Duration | 26 Months |
| Teams Collaborated with | 10 |
| Systems Installed & Commissioned | 176 |
| Partners Trained & Certified | 60 |
The B-Con API Project at MSD’s Ballydine campus represents a landmark investment in Ireland’s pharmaceutical manufacturing future. Valued at €150 million and delivered over a 36-month programme — the longest in Lean Touch Solutions’ MSD portfolio — this project created a dedicated, state-of-the-art greenfield facility specifically designed for the production of Active Pharmaceutical Ingredients (APIs).
APIs are the biologically active components of medicines — the ingredients that actually treat disease. API manufacturing is one of the most tightly regulated, technically demanding, and strategically critical activities in the pharmaceutical industry. The Ballydine API facility produces the core ingredients of life-saving medicines distributed globally through MSD’s international pharmaceutical supply network.
The project was delivered with Jacobs Engineering’s Life Science division as the design and integration lead — one of the world’s most respected pharmaceutical engineering organisations. Lean Touch Solutions worked in close partnership with Jacobs Engineering from the earliest project phases, embedding lean thinking into design and constructability decisions, not just construction execution.
Why greenfield matters: Building an API facility from the ground up means every decision — from site layout and services routing to environmental classification zoning and equipment placement — is made once, under construction conditions. Getting those decisions right the first time, through collaborative planning and systematic waste elimination, is exactly what lean construction delivers. There is no retrofit, no workaround — only the building as designed and commissioned.
Active Pharmaceutical Ingredient manufacturing encompasses a complex series of chemical synthesis and purification processes — each with unique equipment requirements, environmental controls, and quality standards. The Ballydine API facility was designed and built to house multiple API process environments:
Multi-step organic synthesis of active drug compounds — requiring precisely controlled reactor environments, temperature management, and material handling.
Chromatography, crystallisation, and filtration systems — removing impurities and isolating the pure API in compliant form and particle size.
Controlled drying and particle size reduction — preparing the API in the precise physical form required for downstream formulation into drug products.
On-site analytical and QC laboratories for in-process testing, release testing, and stability studies — integral to GMP-compliant API production.
HVAC, purified water, process gases, fire suppression, and environmental monitoring — 176 complex systems supporting all API manufacturing operations.
Controlled-conditions storage, material handling, and logistics infrastructure — ensuring GMP integrity from raw material receipt to API finished goods dispatch.
Jacobs Engineering's Life Science division served as the design and engineering integration lead for the Ballydine API facility. This partnership required Lean Touch Solutions to integrate our lean construction programme not just with trade contractors, but with one of the world's most respected pharmaceutical engineering organisations. Our early engagement with Jacobs Engineering — influencing constructability decisions during design phases, aligning lean planning sequences with detailed engineering outputs, and coordinating lean commissioning with Jacobs' CQV workflows — was a distinctive feature of this project's delivery model.
Our Lean Programme –
Lean Touch Solutions was engaged to deliver a comprehensive lean construction strategy specifically tailored for the unique challenges of greenfield API facility construction. Our core mission aligned precisely with MSD’s project goals: deliver on schedule, meet regulatory standards without compromise, and uphold exceptional safety and quality levels throughout 36 months of complex system installation and commissioning.
Constructing a new API facility brings inherent complexity — tight regulatory oversight, technically intricate system installations, high-risk integration challenges between chemical process systems, and the absolute requirement for GMP compliance at every stage. In response, we applied lean principles not as an add-on, but as a core strategy embedded across the project lifecycle.
Pull Planning is a scheduling methodology that builds the project schedule backwards from a defined completion milestone — asking at each stage “what needs to be complete before this can happen?” rather than “when do we want to start this?” On an API facility with 176 interdependent systems, pull planning is not just useful — it is the only approach capable of managing the sequencing complexity.
Lean Touch Solutions deployed pull planning across all 10 specialist teams at Ballydine — creating phase pull plans for major construction milestones, look-ahead plans for 6-week windows, and weekly work plans with commitment tracking. The result was a scheduling system that reflected reality rather than aspiration, enabling proactive constraint removal rather than reactive damage control.
Greenfield New Build: The only pure greenfield project in Lean Touch Solutions’ MSD portfolio — every system, every service, every environmental zone built from the ground up. The longest engagement at 36 months.
Accurate and dependable scheduling — collaborative weekly work planning across all 10 teams with structured constraint removal to maintain predictability.
Just-in-time resource sequencing built backwards from milestones — aligning installation with resource availability.
End-to-end workflow mapping to streamline installation and commissioning — identifying waste and improving flow.
Structured problem-solving framework — resolving complex challenges early to avoid delays.
Real-time project visibility across teams — improving communication and decision-making.
Embedding a unified, quality-focused culture across teams — ensuring consistent delivery excellence.
Programme Focus Areas –
Our lean approach was explicitly designed around four core priorities — each directly addressing the inherent challenges of greenfield API facility construction and 36-month programme management.
Implementation Approach –
Our approach was grounded in the collaborative development of a bespoke lean construction strategy designed to address the unique challenges of API facility construction. From the outset, we partnered closely with MSD’s project leadership, Jacobs Engineering, main contractors, trade partners, specialist vendors, and automation experts — embedding lean thinking into project planning from the earliest design phases.
Lean Touch Solutions engaged with Jacobs Engineering during the detailed engineering phase — influencing constructability decisions, optimising system installation sequences before construction began, and aligning lean programme milestones with Jacobs' engineering delivery schedule. This early engagement prevented dozens of costly design-construction conflicts before they could impact the programme.
Full buy-in secured from MSD leadership, Jacobs Engineering, all 10 trade teams, specialist vendors, and automation experts. Lean programme launched with pull planning sessions establishing the phase plan for the greenfield build. 180 partners enrolled in the lean training and certification programme — embedding the lean mindset across the complete delivery workforce from the first week of construction.
Last Planner® System embedded across all 10 teams — weekly work planning cycles, 6-week look-ahead scheduling, and structured constraint removal. Pull planning sessions used to build and maintain phase schedules aligned with API system commissioning sequences. Percent Plan Complete (PPC) tracked weekly providing objective data for continuous improvement across the 36-month programme.
VSM deployed as the 176 API systems entered installation — mapping installation and commissioning workflows to identify bottlenecks and interdependency risks. A3 Problem Solving framework used to address complex system integration challenges systematically as they emerged across the chemical process, purification, utility, and QC system families.
Lean programme seamlessly extended into Commissioning, Qualification, and Validation — applying pull planning to IQ/OQ/PQ protocol execution across all 176 systems. Visual management adapted to commissioning workflows. A3 problem solving used to rapidly resolve technical commissioning challenges as the facility moved from construction to GMP-compliant operational readiness for API production.
Outcomes & Results –
The lean programme on the Ballydine API project delivered on every critical metric — schedule, quality, regulatory compliance, system commissioning, and partner capability — across the most demanding greenfield pharmaceutical build in Lean Touch Solutions’ portfolio.
Facility delivered on time across 24-month construction & commissioning programme
Complex API systems installed, commissioned, and GMP validated
Partners trained and certified in lean construction and pull planning
Specialist teams coordinated through one unified lean planning system
Lean Construction for API Facilities –
Active Pharmaceutical Ingredient manufacturing facilities are among the most technically complex and regulatory-sensitive construction environments in existence. API synthesis processes involve hazardous chemicals under precise temperature and pressure conditions. Every system interface must be validated before the next process step can be qualified. Every construction decision has regulatory implications that reach forward to the marketing authorisation of the medicines produced in the facility.
In this environment, the predictability, transparency, and collaborative commitment that lean construction creates are not conveniences — they are requirements. When 10 specialist teams must coordinate the installation and commissioning of 176 interdependent systems to a GMP standard, over 36 months, on a greenfield site — pull planning and Last Planner® System are the only tools capable of keeping the programme on track.
Lean Touch Solutions’ partnership with Jacobs Engineering on this project demonstrates our ability to operate at the highest level of pharmaceutical engineering delivery — integrating lean construction principles with world-class engineering design to create a facility that MSD can rely on for decades of API production. We are an LCI-registered lean construction trainer in Ireland, and our Ballydine API programme is proof of what lean delivers on the most technically demanding builds.
Greenfield builds require lean from day one — embedded in design, not bolted on at construction. Let’s talk about your programme.
From blank site to GMP-compliant API production — lean construction that delivers greenfield pharmaceutical facilities on schedule, on standard, and ready to manufacture.
Pull Planning — building the project schedule backwards from completion milestones — is uniquely powerful in API facility construction because it forces a reality-based view of system interdependencies. When commissioning system 47 requires system 22 to be qualified first, which requires system 9 to be operational, which requires the utility system to be validated — pull planning surfaces that chain from the beginning, not at the moment of crisis.
Lean Touch Solutions’ engagement on the Ballydine API project extended into the design phase — working with Jacobs Engineering’s Life Science division to influence constructability, optimise installation sequences, and align lean planning milestones with engineering deliverables before construction began.
This is what distinguishes embedded lean construction from project management support — the ability to integrate lean thinking into design and engineering decisions, preventing problems at source rather than managing them in the field. Our partnership with Jacobs Engineering demonstrates that lean construction can operate at the highest level of pharmaceutical engineering delivery.
Greenfield pharmaceutical construction is uniquely challenging because every decision is irreversible. On an active-site expansion, mistakes can be corrected against an existing infrastructure baseline. On a greenfield, there is no baseline — every dimension, every service routing, every classification zone boundary, and every validation point is established for the first time on this project.
This is why lean construction — specifically the collaborative planning, early constraint identification, and systematic problem-solving that the Last Planner® System and A3 provide — is not just beneficial on a greenfield API build. It is the foundation that everything else depends on.
Lean Touch Solutions has delivered lean construction programmes across six MSD pharmaceutical facilities in Ireland — a combined programme value exceeding €2.5Bn. From the €1Bn Swords biotech campus to the €150M Ballydine API greenfield build, our practitioners have worked in every major pharmaceutical construction environment that Ireland’s life sciences sector produces.
We are an LCI-registered lean construction trainer based in Naas, Co. Kildare. If you are planning a greenfield API, biotech, or pharmaceutical facility anywhere in Ireland or Europe, contact our team to discuss how lean construction from design stage through CQV can transform your delivery.
