Facility Life Cycle
From design, through installation, commissioning, qualification, validation, to stable, sustaining operations, including continuous improvement – delivering compliant, cost-effective operations in Bio-pharmaceutical operations.
When a leading global bio-pharmaceutical manufacturer set out to build one of Ireland’s most advanced greenfield life sciences facilities, they weren’t just looking for technical support – they needed a trusted engineering partner. From commissioning and construction through to operations and maintenance, and calibration, the goal was clear: establish a collaborative partnership that could guide the client through start-up and continue to deliver value as the facility scaled.
Scaling Engineering Support That Grew with our Cient’s Facility
LotusWorks began supporting this global bio-pharmaceutical client in 2019 with a small team of 8 engineers. Since then, we have grown into a fully embedded 54-person team, delivering trusted expertise across utilities operations, maintenance, and site-wide calibrations.
From the outset, our technical and engineering experts played a key role in shaping the success of this partnership. Through close collaboration with the client’s engineering and quality teams, we established a partnership rooted in trust and shared goals. The LotusWorks team built the calibration programme from the ground up, implemented preventative and predictive maintenance systems, championed continuous improvement at every stage – delivering performance that is powered by our people.
With over €886,000 in validated client savings, 4,500+ calibrations completed annually, and zero missed GMP deadlines to date, our embedded team has supported uninterrupted operations from day one—delivering compliance, consistency, and confidence through technical excellence and trusted partnership.
“From day one, our focus was on building a team that could adapt with the facility. This project challenged us to be agile, technically sharp, and deeply integrated with the client’s engineering function. It’s been rewarding to see that trust grow over time as we’ve delivered value beyond day-to-day operations.”
– Joe Crawley, Site Lead at LotusWorks
| Metric | Value |
|---|---|
| Annual Calibrations | 4,500 |
| Validated Client Savings | €886,000 |
| Personnel on Site | 54 |
| Missed GMP Deadlines | 0 |
Building the Foundation
In 2019, this state-of-the-art manufacturing facility, which is one of the first and was one of the largest green-field bio-pharmaceutical projects in Ireland, was preparing to be brought online. The project demanded a trusted partner capable of building a Sustaining and Sustaining Calibrations Team to support start-up operations with a vision of then maintaining a partnership with the team long-term on-site.
With strict timelines, complex GMP utility systems, and the need for robust calibration and maintenance procedures from the outset, the challenges were substantial. LotusWorks planners collaborated with project stakeholders to align on timelines, ensure the feasibility of milestones and implement engineering plans designed for both immediate and future success.
The expectation was clear: to support project startup and evolve with the facility, ensuring consistent engineering support from initial commissioning through to day-to-day operations.
Scaling Support
LotusWorks deployed its initial team in August 2019 to support utilities and process equipment installation. This team delivered on several key project milestones:
- Reviewed vendor design packages
- Participated in HAZOP studies
- Procured tools, consumables and spare parts
- Developed the site’s calibration program
- Built the CMMS foundations for both utilities and calibration planning, including preventive and predictive maintenance strategies
As the facility transitioned into the operational phase, the LotusWorks team scaled up rapidly, assuming full responsibility for Utilities O&M, Vendor Management, Calibration Scheduling and Execution. By year two, the team had grown to 32, operating a 24/7 utilities shift model and managing critical infrastructure, including electrical systems and all calibration services.
In 2022, the site marked a new milestone with the handover of the first GMP utility systems and the launch of a site-wide Continuous Improvement Programme, including:
- PM rationalisation
- Execution of 12-month PM schedules across disciplines
- Increased efficiencies through collaborative client engagement
| Facility Operational Transition Timeline | |
|---|---|
| Phase | Key Highlights |
| Operational Phase Launch |
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| 2022 Milestone |
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By this point, the LotusWorks team was fully embedded, working side-by-side with the client’s engineering and operations personnel.
Sustained Performance. Embedded Partnership
Today, the site is supported by a trusted, high-performing LotusWorks team of 54 technical and engineering experts – scaled from an initial team of just eight. Working in close collaboration with site stakeholders, the team now delivers end to end support across sustaining operations, maintenance and calibration. With all equipment completing multi-year preventative maintenance cycles and monthly calibrations consistently delivered on schedule, the result for our client is uninterrupted GMP compliance, reduced risk and continued operational confidence.
“LotusWorks brought consistency and deep technical knowledge to a very dynamic project. Their team quickly became an essential part of our site operations, supporting critical utilities and calibrations with professionalism and accountability. We value the partnership and the performance they continue to deliver.”
—Senior Engineering Manager, Global Pharmaceutical Client
The LotusWorks team is fully integrated with the client’s engineering and operations functions—attending daily planning meetings, contributing to strategic reviews, and identifying opportunities to optimise compliance, cost, and uptime. With daily integration into client planning and engineering teams, LotusWorks operates not as a vendor, but as a trusted part of the site’s core function.
LotusWorks technical and engineering teams continue delivering results at scale for our clients across the globe —reducing compliance risk, improving uptime, and unlocking long-term savings for global clients. Whether you’re building from the ground up or looking to optimise your existing operations, speak to a member of the LotusWorks team to see how we can help you stay compliant, agile, and ahead of the curve.