GMP Process Engineer: Aseptic Manufacturing & Optimization

American Regent; Shirley (NY); On-site; USD 91,000 - 100,000; Full time

Job summary

American Regent is seeking a Process Engineer to manage aseptic manufacturing support, drive process improvements, and lead cross‑functional teams in an FDA‑regulated environment. The role covers development, documentation, procurement, and implementation of equipment and processes to enhance quality, efficiency, and cost savings.

The engineer will chair meetings, present to leadership, and ensure thorough communication across the organization, while maintaining strict adherence to SOPs and

Qualifications

• Bachelor’s degree in engineering or sciences; manufacturing experience preferred.
• Experience with cGMP and FDA regulated environments.
• Strong documentation and SOP writing skills.
• Proven cross‑functional leadership and project management abilities.
• Excellent communication and problem-solving skills.

Responsibilities

• Manage multiple process improvement projects with timelines and budgets.
• Perform FAT for manufacturing equipment and validate installations.
• Collaborate with maintenance, QA, and manufacturing to improve quality and efficiency.
• Lead change control initiatives to address root causes identified in investigations.
• Develop and maintain procedures to meet cGMP requirements.
• Provide KPI data and lead meetings with leadership to present findings.

Education

Lean Six Sigma certification

Tools

MS Project

AutoCAD

SolidWorks

Visio

Job description

American Regent is seeking a Process Engineer to manage aseptic manufacturing support, drive process improvements, and lead cross‑functional teams in an FDA‑regulated environment. The role covers development, documentation, procurement, and implementation of equipment and processes to enhance quality, efficiency, and cost savings.

The engineer will chair meetings, present to leadership, and ensure thorough communication across the organization, while maintaining strict adherence to SOPs and