Senior Aseptic Process Engineer — Scale-Up Innovator

RXinsider LTD.; Town of Brookhaven (NY); On-site; USD 110,000 - 125,000; Full time

Job summary

Amneal in New York seeks a Senior Process Engineer to ensure compliant, efficient sterile manufacturing transfer from concept to launch, including scale-up and aseptic simulations.

You will lead continuous improvement, provide SME support for filling, packaging, Lyophilization, depyrogenation and root-cause analysis, and drive investigations to resolve deviations while ensuring cGMP and environmental safety standards.

Qualifications

• 5+ years in GMP manufacturing engineering, sterile/aseptic environments.

Responsibilities

• Develop, validate, and monitor aseptic processes per FDA and cGMP.
• Lead transfer from development to scale-up and commercial production.
• Troubleshoot complex equipment and process deviations; drive CAPA.
• Support SME activities across filling, packaging, and containment systems.

Skills

cGMP knowledge

FDA regulations

Project leadership

Problem solving

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Process validation

Qualification of automated systems

Job description

Amneal in New York seeks a Senior Process Engineer to ensure compliant, efficient sterile manufacturing transfer from concept to launch, including scale-up and aseptic simulations.

You will lead continuous improvement, provide SME support for filling, packaging, Lyophilization, depyrogenation and root-cause analysis, and drive investigations to resolve deviations while ensuring cGMP and environmental safety standards.