Senior Process Engineer - GMP Manufacturing

Curium Pharma; Noblesville (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

Curium seeks a Senior Process Engineer to drive process improvement and reliability at the Noblesville, Indiana facility. You will develop solutions, implement change controls, and troubleshoot equipment within a cross-functional team environment focused on radiopharmaceutical manufacturing.

The role requires experience in GMP manufacturing, validated processes, and collaboration with R&D, QA/QC, and Validation to ensure cGMP compliance and timely product launches.

Qualifications

• Bachelor degree in engineering with discipline aligned to role.
• 5+ years in a cGMP manufacturing environment.
• Experience in process optimization and KPI development.

Responsibilities

• Lead process improvement and reliability efforts for manufacturing processes or equipment.
• Collaborate on cross-functional projects to implement robust processes for new products.
• Create technical documentation for equipment and process improvements.
• Investigate deviations and propose corrective and preventive actions.
• Support product launch activities and new manufacturing lines.
• Collaborate to move projects from scoping to implementation.

Skills

cGMP manufacturing

Process optimization

Project management

Root Cause Analysis

Cross-functional collaboration

Agile

Lean Six Sigma

Automated visual inspection

Travel readiness

Validation

Education

Bachelor's degree in Engineering

Mechanical Engineering preferred

Tools

Validation

Quality Systems

Document Control

Job description

Curium seeks a Senior Process Engineer to drive process improvement and reliability at the Noblesville, Indiana facility. You will develop solutions, implement change controls, and troubleshoot equipment within a cross-functional team environment focused on radiopharmaceutical manufacturing.

The role requires experience in GMP manufacturing, validated processes, and collaboration with R&D, QA/QC, and Validation to ensure cGMP compliance and timely product launches.