Quality Engineering - NPI
BioTalent Ltd, New York, NY, United States
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
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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
#J-18808-Ljbffr