Senior Process Engineer – GMP Manufacturing & Process Improvement

Curium Pharma; Maryland Heights (MO); On-site; USD 90,000 - 120,000; Full time

Job summary

Curium, a leading nuclear medicine company, seeks a Senior Process Engineer for our Maryland Heights facility. You will lead process improvements, troubleshoot equipment and drive CAPA in a highly regulated GMP environment.

You will collaborate with R&D, QA, Validation and Manufacturing to deliver reliable, compliant manufacturing solutions. The role requires strong project management, root-cause analysis and experience with validated processes.

Qualifications

• Bachelor degree in Engineering; Mechanical preferred or related engineering field.
• Five+ years in cGMP manufacturing environments.
• Strong process optimization and KPI establishment experience.
• Knowledge of automated visual inspection or pharmaceutical packaging is a plus.
• Familiarity with cGMP, validation, quality systems and document control.

Responsibilities

• Lead process improvement and reliability efforts for manufacturing processes and equipment.
• Collaborate on cross-functional projects to design and implement robust processes for new products.
• Write protocols and reports for equipment/process improvements.
• Initiate deviations to drive root-cause investigations and CAPA.
• Support product launches and scaling of manufacturing lines.

Skills

Process optimization

Root Cause Analysis

cGMP

Project Management

Lean Six Sigma

Cross-functional collaboration

Documentation

Vigilant communication

Education

Bachelor's degree in Engineering

Job description

Curium, a leading nuclear medicine company, seeks a Senior Process Engineer for our Maryland Heights facility. You will lead process improvements, troubleshoot equipment and drive CAPA in a highly regulated GMP environment.

You will collaborate with R&D, QA, Validation and Manufacturing to deliver reliable, compliant manufacturing solutions. The role requires strong project management, root-cause analysis and experience with validated processes.