Selected Work

Six programmes, six problems that were not moving.

Each case study follows the same structure: the business problem, how it was approached, what it delivered, and what it demonstrates.

01

Closing a Portfolio Gap: Coated Plunger, Concept to Launch in Under Two Years

Datwyler Healthcare · Global Platform Leader

Challenge

The prefilled syringe portfolio had a visible hole. Customers formulating sensitive biologics needed a coated plunger the company could not offer, and competitors were in the space. In a market where a new primary packaging component typically takes five years to reach qualification, the gap was widening faster than a conventional development programme could close it.

Approach & Solution

I defined the user requirements directly with pharmaceutical customers rather than deriving them internally, then assembled and led a cross-functional development team across R&D, production, quality and regulatory. Development, validation planning and customer qualification activities were run in parallel instead of in sequence, with regulatory documentation prepared alongside technical work so nothing waited on paperwork. I kept customers involved throughout, turning their evaluation cycles into de-risking rather than a final hurdle.

Results

Launched in under two years against a typical five-year timeline. The product attracted immediate customer interest and progressed smoothly through qualification at multiple global pharmaceutical companies, becoming a cornerstone of the platform's future sales growth.

This programme demonstrates the combination that defines my work: enough technical depth to make development decisions, and enough commercial judgement to know which gap is worth an accelerated timeline.

02

Rescuing a Stalled Steam Sterilisation Validation

Datwyler Healthcare · Global Process Engineer, Sterilisation

Challenge

A validation programme for steam-sterilised ready-to-use rubber components had stalled repeatedly. External consultants had not delivered, the company could not bring RTU rubber to market, and the CEO asked me personally to take it over — from a US site, with no prior background in steam sterilisation.

Approach & Solution

I relocated to the United States for a year and took direct ownership. I taught myself steam sterilisation science to the level required to challenge and direct the work, then replaced the underperforming external consultants. I built and led an 11-person team spanning production, quality, R&D, supply chain and remaining contractors, and rebuilt the validation strategy around evidence the organisation could defend to customers and inspectors.

Results

A validated steam sterilisation process delivered within twelve months, after years of no progress. It enabled Datwyler to bring ready-to-use rubber components to market for the first time. In parallel, I maintained uninterrupted product management coverage for prefilled syringes and cartridges.

A demonstration of turnaround leadership under executive scrutiny: relocate, learn the science, replace what is not working, and finish.

03

Building a Global Validation & Qualification Framework from Zero

Datwyler Healthcare · Global Validation & Qualification Manager

Challenge

Five production plants manufacturing parenteral rubber closures and aluminium caps were operating without a common validation and qualification approach. Customer audits were inconsistent, engineers were improvising documentation, and GMP and ISO expectations were rising across the industry.

Approach & Solution

I wrote a global validation and qualification policy and the detailed procedures and work instructions beneath it, covering facility and utility qualification, equipment qualification and process validation. Rather than issuing policy and leaving plants to interpret it, I trained approximately 20 engineers and quality managers across all five sites and supplied templates that cut the documentation burden substantially. My work on the ISO 15378 task force kept the framework aligned with where the standard was heading.

Results

A single, enforceable framework adopted across the network. It reduced documentation effort for engineers, standardised customer audit responses, and remains in use and customer-accepted today.

Systems outlive the people who build them when they are designed for the person who has to use them at 4pm on an audit day.

04

Validating a Greenfield Plant in India

Datwyler Healthcare · Global Validation & Qualification Manager

Challenge

A new manufacturing site had to be qualified from an empty building to customer-approved production. It was also the first real test of whether the new global validation framework would survive contact with a live, high-pressure project in an unfamiliar operating environment.

Approach & Solution

I ran the qualification personally on site rather than delegating it — facilities, utilities, equipment qualification and process validation, applying the framework end to end and correcting it where reality disagreed with the procedure. Working alongside local engineering and quality teams, I transferred the approach as the plant came up, so the site owned its own compliance from the first batch.

Results

A fully validated greenfield plant and a framework proven in practice, not just on paper. The approach it established is still accepted by customers auditing the network today.

Proof that a global standard is only credible once its author has applied it themselves, in the hardest case available.

05

Turning a Neglected Account into the Fastest-Growing One

Datwyler Healthcare · Project Manager, Injection Systems

Challenge

An injection systems project had been left without an owner. The customer was dissatisfied, timelines were uncertain, and production readiness had not been seriously planned. The relationship was close to unrecoverable.

Approach & Solution

I took ownership immediately and re-established direct contact with the customer, then applied validation and qualification expertise to build production plans robust enough to commit to. I worked closely with operations to implement them, coordinating engineering, quality, production and supply chain, and kept the customer informed against a plan rather than against optimism.

Results

Delivered on time. The customer went on to become the company's highest-growth account.

Technical credibility is the fastest route to repairing a commercial relationship — customers trust a plan built by someone who knows how the process will actually behave.

06

Opening the Wearable Drug Delivery Segment

Datwyler Healthcare · Global Platform Leader

Challenge

Treatment was shifting from hospital to home, and wearable delivery devices were emerging as the vehicle. No supplier offered rubber components qualified for them. The opportunity was real but early — early enough that securing internal investment required making the case before the market existed.

Approach & Solution

I built the market argument from customer signals and industry direction, then secured internal investment for pilot equipment. I drove early-stage product development against requirements derived from device developers rather than from existing syringe formats, positioning the company alongside the device manufacturers defining the segment.

Results

The company established itself as the leading supplier of compatible rubber components in a space with no existing solutions, with pilot capability in place ahead of competitors and a direct stake in the industry's move toward home care.

Platform leadership means committing capital and engineering time to a market one cycle before it arrives — and being right.

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