Senior Process Improvement Engineer

Katalyst CRO; North Chicago (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO in the United States is seeking a seasoned Process/Manufacturing/Project Engineer to lead manufacturing process improvements, analyze data with SPC, and drive cross-functional initiatives. You will oversee validations, investigations, and site transfer activities, while ensuring quality, yield, and regulatory readiness.

The role requires strong communication in English, and 7+ years of relevant experience in pharma process engineering.

Qualifications

• BS/MS/PhD in Chemistry or Engineering, with pharmaceutical relevance.
• 7+ years of technical experience in Process/Manufacturing/Project Engineering.
• Knowledge of sterile pharmaceutical processes and site transfer.
• Strong verbal and written English communication.

Responsibilities

• Lead projects in manufacturing process areas to improve yield, quality, cycle time, and cost.
• Gather and analyze process data using SPC; develop action plans to boost robustness.
• Provide technical support for shop floor issues and execute tasks as required.
• Lead investigations with structured problem solving and root cause analysis.
• Coordinate cross-functional site projects and continuous improvement initiatives.
• Manage smaller teams and short-duration projects within larger programs.
• Implement process validation for changes, new materials, and new tech.
• Maintain process documentation and write technical reports for quality controls.
• Support regulatory audits and inspections; ensure EHS compliance.

Skills

Process engineering

Project leadership

Statistical data analysis

Root cause analysis

Process validation

Regulatory compliance

Communication skills

Education

BS/MS/PhD in Chemistry or Engineering

Job description

Katalyst CRO in the United States is seeking a seasoned Process/Manufacturing/Project Engineer to lead manufacturing process improvements, analyze data with SPC, and drive cross-functional initiatives. You will oversee validations, investigations, and site transfer activities, while ensuring quality, yield, and regulatory readiness.

The role requires strong communication in English, and 7+ years of relevant experience in pharma process engineering.