Meet the W2 Cleanroom Consulting Team

At W2 Cleanroom Consulting, we believe that real expertise comes from hands-on experience. Our consultants have worked within cleanrooms, led aseptic manufacturing teams, and supported facilities through design, validation, and inspection readiness.

Kyle Winn – Director, GMP Consultant

With extensive leadership experience across NHS aseptic manufacturing, GMP consultancy, and sterile production environments, Kyle combines operational expertise with a strong focus on empowering teams to achieve compliance and efficiency. As Head of Production at the NHS North East and North Cumbria Medicines Manufacturing Centre (NENC MMC) and a practising clinical lead within NHS aseptic services, Kyle brings a unique understanding of how governance, workflow design, and regulatory standards come together in practice.

Kyle has successfully led multidisciplinary teams through MHRA inspections, developed robust governance frameworks for aseptic hubs, and supported the implementation of validation and training programmes that underpin regulatory readiness. His experience spans the full lifecycle of aseptic facility development — from early workflow planning and equipment qualification through to operational readiness and ongoing performance management.

Nationally, Kyle has contributed to the development of policy and best practice in aseptic services, working collaboratively across NHS networks to promote consistency and innovation in GMP operations. His consultancy approach is grounded in practical experience, teamwork, and a clear understanding of the challenges faced by NHS aseptic units and commercial partners alike.

Through his work at W² Cleanroom Consulting, Kyle supports clients in designing, validating, and optimising cleanroom facilities, ensuring they meet both regulatory expectations and real-world operational needs. He also co-leads Help Me GMP with Adam Walker sharing accessible, practical GMP training with professionals worldwide to strengthen confidence and competence across the pharmaceutical sector.

Areas of Expertise:

• Cleanroom design and workflow planning

• Aseptic manufacturing governance

• Validation strategy (VMP, IQ/OQ/PQ)

• Operational readiness and training frameworks

Connect:
Email: info@w2cleanrooms.com

Adam Walker – Director, Qualified Person (QP)

With extensive experience across NHS manufacturing, GMP consultancy, and pharmaceutical innovation, Adam combines frontline leadership with a focus on advancing aseptic manufacturing capability within the NHS. As Head of Development and Innovation at the NHS North East and North Cumbria Medicines Manufacturing Centre (NENC MMC) and a contract Qualified Person, Adam brings technical depth and practical insight into maintaining compliance with EU GMP across both NHS and commercial sectors.

Adam has successfully led multiple facility and equipment design projects, including the qualification and factory acceptance testing of complex aseptic systems such as vapour hydrogen peroxide (VHP) isolators. His expertise spans facility commissioning, validation strategy, and the implementation of robust quality systems that underpin both licensed and unlicensed aseptic environments.

Nationally, Adam contributes through the Aseptic Pathfinder Programme, supporting the future direction of NHS medicines manufacturing with a focus on automation, compliance, and sustainable innovation. He also plays an active role in authoring the 6th edition of QAAPS, ensuring consistency and high standards of GMP compliance across NHS facilities.

Through his work at W² Cleanroom Consulting, Adam supports NHS and industry partners in developing compliant, future-ready aseptic units and implementing practical, risk-based GMP frameworks. As co-founder of Help Me GMP alongside Kyle Winn, he shares expert knowledge globally—translating complex regulatory principles into clear, accessible guidance that strengthens operational performance and regulatory assurance.

Areas of Expertise:

• Facility commissioning and validation strategy

• Qualification and testing of aseptic systems (VHP isolators, cleanrooms)

• GMP quality system implementation

• Automation and sustainable innovation in aseptic manufacturing

• Qualified Person (QP) support and EU GMP compliance

Connect:
Email: info@w2cleanrooms.com

Together, we bring a unique dual perspective to every project — combining production and quality expertise to deliver compliant, practical solutions for cleanroom and aseptic facilities.

Our shared philosophy is simple:
Compliance should be practical. Quality should be achievable. Teams should feel confident.

We’re not just advisors... we’re practitioners. Our team combines deep GMP knowledge with a practical understanding of what it takes to run compliant, efficient, and sustainable operations in both NHS and pharmaceutical environments.