A selection of projects across pharmaceutical manufacturing, isolator systems, and international facility builds. Names shared with permission where applicable.
TFS was commissioning and qualifying isolator systems across three continents - each site with its own layout, environmental baseline, and local GMP expectations. The brief was straightforward on paper: develop and validate H₂O₂ bio-decontamination cycles that would work reliably across all of them. In practice, that's where things get interesting.
Isolators aren't flat rooms. They have corners, nested equipment, shadow zones, and internal geometries that make uniform vapour distribution genuinely difficult. The question wasn't just whether a cycle could achieve the required log reduction - it was whether it would do so consistently, across different units, under varying ambient conditions, without needing a different protocol for every site.
Passing qualification is the minimum. The real objective was cycles robust enough that requalification two years later would be routine, not a rescue mission.
Before writing a single protocol, I started with risk assessments on each isolator configuration - mapping internal geometry, airflow patterns, and equipment placement to identify where H₂O₂ vapour was least likely to reach effective concentration. These became the worst-case locations for biological indicator placement, which is the foundation everything else sits on. Get that wrong and the whole qualification is built on a bad assumption.
From there, cycle parameters - concentration, exposure time, humidity conditioning, aeration — were developed and iterated against actual BI results and temperature mapping data. Not all sites behaved the same way; ambient humidity in particular had a measurable effect on cycle performance in some locations, which required site-specific adjustments within an agreed parameter range rather than entirely different cycles.
I supported FAT activities at the manufacturer before the units shipped, then followed through to SAT and qualification on-site. Where deviations occurred — and they did, as they always do in complex multi-site programmes - I led the investigation, documented the root cause, and implemented the corrective action. Nothing left open.
The most technically demanding aspect was managing variability between sites without fragmenting the validation approach. Three different countries means three different regulatory environments, three sets of site QA expectations, and in some cases three different interpretations of what "worst-case" means. Keeping the core methodology consistent while accommodating legitimate local differences required a lot of alignment work up front - and a clear validation master plan that all parties had actually read.
Working across time zones on a live qualification programme is its own kind of challenge. When an unexpected BI failure appears at a site you're not physically present at, clear documentation and pre-agreed decision trees matter enormously. We had both.
All three sites completed qualification with cycles approved for routine use. The requalification programme was designed into the lifecycle plan from the start, so ongoing compliance doesn't depend on repeating the full development exercise - just running a defined reduced protocol against the established worst-case positions.
More broadly, the project demonstrated that a risk-based, documentation-first approach is what makes multi-site validation manageable. When your worst-case rationale is solid and your deviations are investigated properly, the regulatory story writes itself.
Designing a unified requalification framework across two manufacturing sites in Poland - covering HVAC, cleanrooms, and thermostatic equipment that had historically been qualified in isolation from each other.
Contributing to the design, risk assessment, and commissioning of cleanroom and HVAC systems for a large-scale API facility buildout - from supplier qualification through FAT/SAT and handover.
Building and implementing quality management systems from the ground up for pharmaceutical clients in Poland - covering documentation architecture, process mapping, and compliance alignment across both quality and information security standards.