Senior Process Engineer - Sterile Manufacturing

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

Benefits offered by this job

Health benefits and insurance

401(k) matching

Total Rewards program

Job summary

Amneal Pharmaceuticals is seeking a Senior Process Engineer focused on sterile manufacturing to ensure compliant, efficient transfer of new products from concept to launch, including aseptic processing, Lyophilization, and packaging integration.

You will lead continuous improvement initiatives, provide SME-level technical expertise, and drive root cause analyses for process deviations while coordinating cross-functional teams across R&D and Manufacturing.

Qualifications

• Requires 5+ years in engineering roles within GMP manufacturing/Life science with sterile/aseptic facility.
• Bachelor's degree in engineering or related field; Master's preferred.
• Strong understanding of cGMP, FDA regulations, and related standards.

Responsibilities

• Develop, author, and execute protocols to ensure FDA and cGMP compliance, including validation and qualification.
• Lead transfer of processes from development to scale-up and commercial production in collaboration with R&D and Manufacturing.
• Provide real‑time troubleshooting for equipment failures and deviations; lead investigations and CAPA.
• Develop and revise SOPs; manage change controls and documentation for batch records and process improvements.
• Monitor KPIs (quality, yield, throughput, cycle time) to drive continuous improvement.

Skills

Sterile manufacturing

GMP compliance

Project management

Root cause analysis

Technical writing

Education

Bachelor's Degree in Engineering

Master's Degree (preferred)

Tools

Minitab

Excel

AutoCAD

Job description

Amneal Pharmaceuticals is seeking a Senior Process Engineer focused on sterile manufacturing to ensure compliant, efficient transfer of new products from concept to launch, including aseptic processing, Lyophilization, and packaging integration.

You will lead continuous improvement initiatives, provide SME-level technical expertise, and drive root cause analyses for process deviations while coordinating cross-functional teams across R&D and Manufacturing.