Sterile Process Engineer: Formulation & Tech Transfer

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

Benefits offered by this job

Comprehensive benefits

401(k) matching

Career development

Job summary

Amneal is seeking a Senior Process Engineer for sterile manufacturing in New Jersey. You will translate concepts into validated, compliant processes, scale up for commercial production, and lead continuous improvement initiatives.

The role requires SME guidance on aseptic filling, lyophilization, depyrogenation, and root cause analysis. You will develop protocols, monitor KPIs, and collaborate with R&D, manufacturing, and vendors to optimize processes, validate systems, and ensure cGMP

Qualifications

• Knowledge of cGMP and FDA regulations.
• Experience in GMP manufacturing environments and sterile/aseptic facilities.

Responsibilities

• Develop, author, and execute validation and cleaning validation protocols.
• Collaborate with R&D and Manufacturing to scale up processes.
• Provide real-time troubleshooting for equipment failures and deviations.
• Lead investigations, CAPA, and change controls with data analysis.

Skills

cGMP knowledge

FDA regulations

Process engineering

Troubleshooting

Project management

Leadership

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Tools

Engineering software

Qualification documentation tools

Job description

Amneal is seeking a Senior Process Engineer for sterile manufacturing in New Jersey. You will translate concepts into validated, compliant processes, scale up for commercial production, and lead continuous improvement initiatives.

The role requires SME guidance on aseptic filling, lyophilization, depyrogenation, and root cause analysis. You will develop protocols, monitor KPIs, and collaborate with R&D, manufacturing, and vendors to optimize processes, validate systems, and ensure cGMP