Senior Process Engineer – Pharma Manufacturing

Curium Pharma; Maryland Heights (MO); On-site; USD 110,000 - 150,000; Full time

Job summary

The Senior Process Engineer at Curium Pharma will be a key contributor in a dynamic Noblesville, IN manufacturing facility, supporting radiopharmaceutical sterile product production. The role develops solutions to improve reliability and quality, writing and implementing change controls and CAPAs, and troubleshooting equipment issues.

The ideal candidate has experience in regulated pharma environments, with knowledge of automated visual inspection and vial labeling, and will collaborate across

Qualifications

• Bachelor degree in Engineering; mechanical preferred.
• 5+ years in cGMP manufacturing environments.
• Experience optimizing processes and establishing KPIs.
• Knowledge of cGMPs, validation, and document control.
• Strong project management and teamwork in a regulated setting.

Responsibilities

• Lead process improvement and reliability initiatives for manufacturing processes or equipment.
• Support cross-functional projects through design and implementation of robust processes.
• Write protocols and reports for equipment and process improvements.
• Lead Deviation investigations and implement CAPAs to eliminate root causes.
• Assist in product launches and new manufacturing line implementations.
• Collaborate to move projects from scoping to implementation.
• Work with Quality to ensure cGMP compliance in engineering initiatives.
• Forecast project costs and track milestones.

Skills

Project management

Root Cause Analysis

Cross-functional collaboration

Communication

Agile approach

Education

Bachelor degree in Engineering

Tools

Automated visual inspection

Job description

The Senior Process Engineer at Curium Pharma will be a key contributor in a dynamic Noblesville, IN manufacturing facility, supporting radiopharmaceutical sterile product production. The role develops solutions to improve reliability and quality, writing and implementing change controls and CAPAs, and troubleshooting equipment issues.

The ideal candidate has experience in regulated pharma environments, with knowledge of automated visual inspection and vial labeling, and will collaborate across