Engineer Process Support III

Creative Solutions Services, LLC; North Chicago (IL); On-site; USD 120,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Senior Process/Manufacturing Engineer to lead projects at our North Chicago site in Illinois. You will drive improvements to yield, quality, cycle time, and cost efficiency while coordinating cross‑functional teams.

The role requires 7+ years in Process/Manufacturing or Project Engineering, knowledge of pharmaceutical sterile processes and site transfers, and strong English communication.

Qualifications

• BS, MS, or PhD in Chemistry or Engineering.
• 7+ years of technical experience in Process/Manufacturing/Project Engineering.
• Technical knowledge in fundamentals of pharmaceutical process (sterile product manufacturing), and site transfer.
• Effective verbal and written communication skills in English.

Responsibilities

• Lead projects to improve yield, quality, cycle time, and cost efficiency.
• Gather and analyze process data using statistical process control; develop action plans to improve robustness.
• Provide technical shop floor support and manage assigned tasks.
• Lead investigations with structured problem-solving; document root causes and recommendations.
• Participate in cross-functional site projects for continuous improvement and capacity increases.
• Manage small teams and short-duration projects within larger programs.
• Oversee process validation for operational changes, new materials, and new processes.
• Maintain current process documentation and write technical memos and reports.
• Support regulatory audits and inspections; ensure EHS compliance.

Skills

7+ yrs exp

Process engineering

Project leadership

Education

BS/MS/PhD in Chemistry or Engineering

Tools

SPC (Statistical Process Control)

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