We’re partnering with a high-growth, global life sciences manufacturer at the forefront of single-use bioprocessing technologies.

They’re hiring an NPI Quality Engineer to sit at the intersection of R&D, Manufacturing, and Quality, ensuring new products are designed, validated, and successfully launched into GMP production.

The Role

• Act as Quality lead across New Product Introduction (NPI) programmes
• Drive design controls, risk management (DFMEA / PFMEA), and validation activities (IQ/OQ/PQ)
• Ensure manufacturing readiness for product launch (builds, documentation, transfer)
• Support sterilisation validation (EO, Gamma, E-beam) for single-use products
• Partner cross-functionally to deliver robust, scalable manufacturing processes
• Contribute to CAPA, change control, and continuous improvement

What They Need

• Experience in biotech / pharma / medtech manufacturing quality
• Strong knowledge of ISO 13485 / 9001, GMP, and design controls
• Hands-on experience with validation, risk management, and product transfer
• Exposure to cleanroom manufacturing and sterile products
• Ability to operate across cross-functional product development teams

Why This Role

• Direct impact on bringing new products to market
• Work at the cutting edge of bioprocessing and single-use technologies
• Opportunity to influence product quality from design through to scale