Biopharma Upstream Manufacturing Principal Engineer

WuXi Biologics Group; Northern (KY); Hybrid; USD 150,000 - 190,000; Full time

Job summary

WuXi Biologics Cranbury is seeking a Principal Engineer to lead a high‑performing upstream manufacturing team in a GMP environment. You will develop staff, drive KPI delivery, and ensure GDP/regulatory compliance across shift operations.

Responsibilities include cross‑functional leadership, process optimization, troubleshooting, and ensuring quality systems readiness for new product introductions while maintaining a strong safety culture.

Qualifications

• BS with 8+ years or MS with 6+ years in biopharmaceutical upstream manufacturing.
• Proven leadership of manufacturing teams and staff development.
• Deep knowledge of cGMP, safety and environmental regulations in biotech.

Responsibilities

• Lead a manufacturing team in GMP upstream operations.
• Drive continuous improvement and operational excellence.
• Ensure compliance with GMP, GDP and regulatory requirements.
• Coach and develop staff; manage cross-shift collaboration.
• Review documentation and support change controls as needed.

Skills

Team Leadership

Cross-functional Leadership

Regulatory Compliance

GDP Knowledge

KPI Delivery

Continuous Improvement

GMP Knowledge

Troubleshooting

Education

Bachelor’s degree in biopharmaceutical manufacturing

Master’s degree in biopharmaceutical manufacturing

Tools

DeltaV

AVEVA

Unicorn

LIMS

SAP

TrackWise

Job description

WuXi Biologics Cranbury is seeking a Principal Engineer to lead a high‑performing upstream manufacturing team in a GMP environment. You will develop staff, drive KPI delivery, and ensure GDP/regulatory compliance across shift operations.

Responsibilities include cross‑functional leadership, process optimization, troubleshooting, and ensuring quality systems readiness for new product introductions while maintaining a strong safety culture.