Senior Sterile Process Engineer—Scale-Up & Improvement

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

Job summary

Amneal is seeking a Senior Process Engineer for sterile manufacturing to ensure compliant, efficient transfer of new products from concept to launch. You will scale up processes, simulate aseptic operations, and address deviations while driving continuous improvement.

The role acts as SME for sterile/aseptic, filling, packaging, lyophilization, and root cause analysis, leading CAPA and SOP revisions to meet regulatory requirements.

Qualifications

• Bachelors Degree in Engineering or related field required.
• Master's degree in Engineering preferred.
• 5+ years in GMP manufacturing/biotech with sterile/aseptic facilities.

Responsibilities

• Develop, author, and execute protocols to ensure FDA and cGMP compliance.
• Manage technical plans, studies, and schedules to enable scale-up and production.
• Provide real-time troubleshooting and lead training during start-up.
• Lead change controls, investigations, and CAPA to support continuous improvement.

Skills

cGMP knowledge

Project management

Leadership

Problem solving

Communication

Engineering software/tools

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Engineering software

Job description

Amneal is seeking a Senior Process Engineer for sterile manufacturing to ensure compliant, efficient transfer of new products from concept to launch. You will scale up processes, simulate aseptic operations, and address deviations while driving continuous improvement.

The role acts as SME for sterile/aseptic, filling, packaging, lyophilization, and root cause analysis, leading CAPA and SOP revisions to meet regulatory requirements.