Engineer Process Support III

Job Title: Engineer Process Support III Location: North Chicago, IL

Experience: 5 - 7 Years Duration: 12+ months contract (possibility of extension or conversion to full time)

Overview

We are seeking an Engineer Process Support III to join our team in North Chicago. This role will primarily support a project to qualify an existing sterile ophthalmic product in a new container closure system. In addition, you will contribute to multiple commercially driven projects from feasibility through implementation.

The ideal candidate will bring strong expertise in sterile product support, aseptic process development, process validation, technology transfer, and design control.

Key Responsibilities

Lead projects within manufacturing processes to drive efficiency: yield improvements, quality enhancements, cycle time reduction, and cost savings.

Collect and analyze process data using statistical methods; develop action plans to improve robustness, reduce product loss, and safeguard quality.

Provide technical support for shop-floor challenges and ensure timely resolution of operational issues.

Lead structured investigations, identify root causes, and recommend corrective actions using sound scientific principles. Document deviations and assess impact on quality, yield, and compliance.

Collaborate on cross-functional initiatives (continuous improvement, capacity expansion, cost reduction, process remediation).

Manage smaller-scale projects, including coordination, reporting, and communication across teams.

Lead process validation efforts for operational changes, new materials, or technology introductions. Prepare and review protocols, reports, and supporting documentation.

Maintain accurate and compliant process documentation, including technical reports, quality memos, and manufacturing records.

Provide technical support during audits and regulatory inspections.

Ensure compliance with EHS programs and demonstrate accountability for safe practices.

Qualifications

• BS or MS in Chemistry or Engineering (Chemical, Mechanical, Biochemical, or related field).

• 5–7 years of experience in Process, Manufacturing, or Project Engineering.

• Strong technical knowledge in sterile pharmaceutical manufacturing.

• Proficiency in data analysis and statistical process control.

• Effective communication skills (verbal and written).

• Preferred / Nice to Have

• Experience in sterile GMP environments.

• Background in Project Management, IND/BLA submissions, or Six Sigma certification.

• Hands-on ophthalmic or eyecare product development/manufacturing experience.

• Top Skills Required

• Sterile product and aseptic process development (hands-on).

• Process validation and technology transfer.

• Design control expertise.

• Strong data analysis and statistical skills.

• Clear communication and technical writing.