Senior Process Engineer, GMP Pharma & Automation

Curium Pharma; Maryland Heights (MO); On-site; USD 110,000 - 160,000; Full time

Job summary

The Senior Process Engineer at Curium Pharma Noblesville, IN will lead process improvements for radiopharmaceutical manufacturing, developing solutions and implementing new technology to enhance reliability and quality.

You will write protocols, support deviations, participate in cross-functional teams (R&D, QA, Validation, Manufacturing), and help launch new manufacturing lines while ensuring cGMP compliance.

Qualifications

• Bachelor degree in Engineering; Mechanical preferred, others considered.
• Five+ years of experience in cGMP manufacturing environments.
• Experience in process optimization and KPI development.
• Knowledge of automated visual inspection and pharmaceutical packaging is desired.
• Strong QA/validation, document control, and regulatory awareness.

Responsibilities

• Lead process improvement and troubleshooting of manufacturing processes or equipment.
• Support cross-functional projects through process evaluation, design, and implementation of robust processes for new products within existing or new manufacturing equipment.
• Write technical documentation, including protocols and reports for equipment and process improvements.
• Author deviations to investigate root causes and propose corrective and preventive actions.
• Support product launch activities and implementation of new manufacturing lines.
• Work collaboratively to move projects from scoping to implementation.
• Partner with Quality to ensure implementation of cGMP practices.
• Provide input into forecasts for project-related costs and track project tasks against milestones.
• Assist in development and maintenance of process equipment, procedures, batch records, and training materials.

Skills

Process optimization

Project management

Communication

Cross-functional collaboration

Root Cause Analysis

Agile

Lean Six Sigma

cGMP knowledge

High-pressure environments

Travel willingness

Education

Bachelor's degree in Engineering

Mechanical Engineering degree preferred

Job description

The Senior Process Engineer at Curium Pharma Noblesville, IN will lead process improvements for radiopharmaceutical manufacturing, developing solutions and implementing new technology to enhance reliability and quality.

You will write protocols, support deviations, participate in cross-functional teams (R&D, QA, Validation, Manufacturing), and help launch new manufacturing lines while ensuring cGMP compliance.