Engineer Process Support III

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

Roles And Responsibilities

• Lead projects in manufacturing process areas to achieve process efficiencies such as increased process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.
• Gather and analyze process data using statistical process control methodology. Develop action plans to increase process robustness, prevent product loss, and control quality impact. Participate in process performance monitoring such as Track & Trend.
• Provide technical support in the resolution of shop floor situations and execute assigned tasks as required by the operational area.
• Lead investigations by following a structured problem-solving approach and employing sound, scientific principles when identifying root cause and developing recommendations related to product and process. Generate technical justification to support and/or document process deviations/investigations and determine impact on product quality, yield, and product registration.
• Participate as part of a cross-functional team responsible for implementation of site projects/initiatives, including continuous improvement, cost reduction, capacity increase, etc., that lead to process remediation.
• Manage smaller team, short-duration projects within larger projects. Responsibilities may include project coordination, monitoring, reporting, meeting management, and team communication.
• Lead the implementation of process validation for operational changes, new raw materials, and introduction of new process/technology. Generate technical justification determining impact of change and protocols/reports/manufacturing documents that support its execution. Assist the execution of experimental, demonstration, and validation lots.
• Maintain up-to-date product process documentation and assure they are in compliance with applicable procedures and regulations. Write justification memos and scientific reports of quality controls and manufacturing documents.
• Provide scientific and technical support during regulatory audits and agency inspections.
• Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of client's EHS program.

Education And Experience

• BS, MS, or PhD in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field).
• 7+ years of technical experience in Process/Manufacturing/Project Engineering or similar role.
• Technical knowledge in fundamentals of pharmaceutical process (sterile product manufacturing), and site transfer.
• Effective verbal and written communication skills in English.

Key Stakeholders

• Manufacturing
• Quality
• Supply Chain
• Operational Excellence
• Engineering
• EHS