Senior Sterile Process Engineer – Manufacturing Excellence

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); On-site; USD 100,000 - 120,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Senior Process Engineer in sterile manufacturing to ensure compliant, efficient transfer of new products from concept to launch, including scale-up and aseptic process simulation. The role serves as SME for sterile/aseptic filling, packaging, Lyophilization, and effective deviation investigations.

The position requires 5+ years in GMP sterile manufacturing, strong project management, and ability to lead cross-functional teams to drive continuous

Qualifications

• 5+ years of engineering experience in GMP manufacturing environments (sterile/aseptic).
• Experience leading process transfer from concept to launch and scale-up.

Responsibilities

• Develop protocols to ensure FDA/cGMP compliance, validation, and qualification.
• Lead process improvements and troubleshoot complex manufacturing equipment.
• Support transition of processes from development to full commercial production.

Skills

GMP knowledge

Project management

Leadership

Analytical thinking

Education

BA/BS in Engineering

MS in Engineering (preferred)

Tools

Engineering software

Job description

Amneal Pharmaceuticals LLC is seeking a Senior Process Engineer in sterile manufacturing to ensure compliant, efficient transfer of new products from concept to launch, including scale-up and aseptic process simulation. The role serves as SME for sterile/aseptic filling, packaging, Lyophilization, and effective deviation investigations.

The position requires 5+ years in GMP sterile manufacturing, strong project management, and ability to lead cross-functional teams to drive continuous