Quality Engineering - NPI

BioTalent Ltd; Georgia; On-site; USD 75,000 - 95,000; Full time

Job summary

BioTalent Ltd is seeking an NPI Quality Engineer in Georgia, USA, to lead quality initiatives in new product introductions. This role involves driving design controls, managing risk assessments, and validating manufacturing processes. The ideal candidate should have experience in biotech or pharma manufacturing quality, strong knowledge of ISO and GMP standards, and hands-on experience with validation and product transfer. The position offers the opportunity to impact product quality and play a significant role in launching innovative bioprocessing technologies.

Qualifications

• 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.

Responsibilities

• Act as Quality lead across New Product Introduction (NPI) programmes.
• Drive design controls, risk management, and validation activities.
• Ensure manufacturing readiness for product launch.
• Support sterilisation validation for single-use products.
• Partner cross-functionally to deliver manufacturing processes.
• Contribute to CAPA, change control, and continuous improvement.

Skills

biotech / pharma / medtech manufacturing quality

ISO 13485 / 9001

GMP

design controls

validation

risk management

product transfer

cleanroom manufacturing

ability to operate in cross-functional teams

Job description

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

They’re hiring anNPI Quality Engineerto sit at the intersection ofR&D, Manufacturing, and Quality, ensuring new products are designed, validated, and successfully launched into GMP production.

The Role

• Act as Quality lead acrossNew Product Introduction (NPI)programmes
• Drivedesign controls, risk management (DFMEA / PFMEA), and validation activities (IQ/OQ/PQ)
• Ensuremanufacturing readinessfor product launch (builds, documentation, transfer)
• Supportsterilisation validation (EO, Gamma, E-beam)for single-use products
• Partner cross-functionally to deliverrobust, scalable manufacturing processes
• Contribute toCAPA, change control, and continuous improvement

What They Need

• Experience inbiotech / pharma / medtech manufacturing quality
• Strong knowledge ofISO 13485 / 9001, GMP, and design controls
• Hands‑on experience withvalidation, risk management, and product transfer
• Exposure tocleanroom manufacturing and sterile products
• Ability to operate acrosscross‑functional product development teams

Why This Role

• Direct impact onbringing new products to market
• Work at the cutting edge ofbioprocessing and single-use technologies
• Opportunity to influenceproduct quality from design through to scale