Senior Manufacturing Process Engineer — Lean Six Sigma

Katalyst CRO; Rockford (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Manufacturing Process Engineer to develop, optimize, and validate production processes in a fast-paced facility in Rockford, IL. You will work cross-functionally with Manufacturing, Quality, R&D, and Supply Chain to implement improvements and ensure compliance with GMP/cGMP standards.

The role emphasizes process validation, CAPA, documentation, and NPI support, with opportunities to lead equipment validation and continuous improvement initiatives.

Qualifications

• Bachelor's degree in an engineering discipline (e.g., Manufacturing, Mechanical, Industrial, Chemical).
• 5+ years of manufacturing or process engineering experience in regulated/high-volume environments.
• Experience with Lean Manufacturing, Six Sigma, and CI methodologies.
• Experience with process validation, root cause analysis, and problem-solving techniques.
• Strong documentation and engineering change control knowledge.
• Excellent analytical, organizational, and communication skills.

Responsibilities

• Develop, implement, and optimize manufacturing processes to improve productivity, quality, and cost efficiency.
• Analyze manufacturing workflows and identify opportunities for process improvements using Lean Manufacturing and Six Sigma.
• Support new product introduction (NPI), process development, and technology transfer activities.
• Design, validate, and document manufacturing processes, including IQ, OQ, and PQ where applicable.
• Investigate production issues, perform root cause analysis, and implement CAPA.
• Create and maintain process documentation, SOPs, and manufacturing specifications.
• Collaborate with cross-functional teams including Mfg, QA, R&D, Maintenance, Supply Chain, and Regulatory Affairs.
• Support equipment selection, installation, commissioning, and validation activities.
• Monitor process performance using SPC and process capability analysis.
• Lead CI initiatives focused on cycle time reduction, waste elimination, yield improvement, and cost savings.
• Participate in FMEA, risk assessments, and process validation activities.
• Train manufacturing personnel on new processes, equipment, and standardized work procedures.
• Prepare technical reports, engineering documentation, and project status updates.

Skills

Lean Manufacturing

Six Sigma

Continuous Improvement

Process Validation

Data Analysis

Documentation

Cross-functional Collaboration

Regulatory Compliance

Education

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

AutoCAD

ERP systems

MES

Job description

Katalyst CRO is seeking a Manufacturing Process Engineer to develop, optimize, and validate production processes in a fast-paced facility in Rockford, IL. You will work cross-functionally with Manufacturing, Quality, R&D, and Supply Chain to implement improvements and ensure compliance with GMP/cGMP standards.

The role emphasizes process validation, CAPA, documentation, and NPI support, with opportunities to lead equipment validation and continuous improvement initiatives.