Senior Process Engineer – Sterile/Aseptic Scale-Up SME

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

Benefits offered by this job

Competitive benefits

401(k) matching

Job summary

Amneal is seeking a Senior Process Engineer for sterile manufacturing to ensure compliant, efficient, and safe transfer of new products from concept to launch. You will scale up processes, support aseptic operations, and act as SME for filling, lyophilization, depyrogenation and QC investigations.

You will lead continuous improvement, manage validation activities, and collaborate with R&D and manufacturing to ensure successful implementation and ongoing process performance in a regulated

Qualifications

• Bachelor's degree in engineering or related field required.
• Master's degree preferred.
• 5+ years in GMP manufacturing with sterile/aseptic experience.

Responsibilities

• Develop and execute FDA/cGMP compliant process validation and qualification protocols.
• Lead transfer of processes from development to scale-up and commercial production.
• Provide real-time troubleshooting and lead investigations to resolve deviations.
• Develop SOPs, CAPA, and support continuous improvement initiatives.

Skills

FDA regulations

cGMP knowledge

Project management

Leadership

Problem solving

Communication skills

Engineering software/tools

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Job description

Amneal is seeking a Senior Process Engineer for sterile manufacturing to ensure compliant, efficient, and safe transfer of new products from concept to launch. You will scale up processes, support aseptic operations, and act as SME for filling, lyophilization, depyrogenation and QC investigations.

You will lead continuous improvement, manage validation activities, and collaborate with R&D and manufacturing to ensure successful implementation and ongoing process performance in a regulated