Manufacturing Process & Operational Excellence Leader

CBG Biotech; Solon (OH); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Paid Time Off

401K match

Flexible work week

Health insurance

Job summary

CBG Biotech, based in Solon, Ohio, seeks an experienced Manufacturing Process & Operational Excellence Lead to build and maintain processes, SOPs, BOMs, and MES workflows that ensure consistent manufacturing and product quality.

You will partner with engineering, quality, and leadership to implement data-driven improvements, lead RCCA investigations, develop dashboards, and drive manufacturing-readiness across the organization. All candidates must pass drug and background screening.

Qualifications

• Bachelor’s degree in Manufacturing/Industrial Engineering or a related field.
• 5+ years of experience in manufacturing engineering, quality systems, manufacturing systems, or process development.
• Demonstrated experience writing and implementing SOPs, work instructions, and controlled manufacturing documentation.
• Experience developing BOMs, routings, drawings and manufacturing records.
• Experience implementing or improving ERP, MRP, or MES processes.
• Working knowledge of engineering change control and configuration management.
• Experience leading root-cause analysis and corrective-action activities.
• Experience developing quality metrics, reports, dashboards, and data-trending tools.
• Understanding of inspection practices and documentation.
• Strong Excel and data-analysis capabilities; Power BI is highly desirable.
• Familiarity with ISO 9001/AS9100 or similar quality-management frameworks.

Responsibilities

• Develop manufacturing processes, routings, operation sequences, labor standards, and production requirements.
• Lead implementation and continued development of MES processes.
• Define how production employees access instructions, record work, document inspections, and complete operations.
• Improve ERP and MES data accuracy, including BOMs, routings, work centers, operation times, and production records.
• Develop standardized production travelers and electronic manufacturing records.
• Identify opportunities for tooling, fixtures, mistake-proofing, and workstation organization.
• Support new product introduction and production-readiness activities.
• Develop, document, and maintain manufacturing and operational SOPs.
• Convert knowledge into repeatable processes and create work instructions and forms.
• Establish document ownership, revision control, and approval requirements.
• Train employees on new processes and verify ongoing compliance.
• Review processes to remove unnecessary steps and clarify responsibilities.
• Develop, review, and maintain BOMs and drawings; ensure configuration control.
• Coordinate engineering change orders and verify changes are implemented.
• Establish controls for revisions and deviations.
• Resolve discrepancies between design and manufacturing practices.
• Lead RCCA investigations and maintain a tracker; assign owners and dates.
• Apply 5-Why, fishbone, and Pareto analyses.
• Verify effectiveness of corrective actions and link to SOPs and training.
• Define data for dashboards and lead regular reviews.
• Provide oversight for inspections and acceptance criteria.
• Develop inspection plans and ensure traceability.
• Coordinate training and compliance activities.

Skills

Manufacturing Engineering

Quality Systems

MES Development

ERP/MRP

Root-Cause Analysis

Data Analysis

Power BI

Project Management

Education

Bachelor's degree in Manufacturing/Industrial Engineering

Tools

Power BI

MS Excel

ERP/MRP systems

Job description

CBG Biotech, based in Solon, Ohio, seeks an experienced Manufacturing Process & Operational Excellence Lead to build and maintain processes, SOPs, BOMs, and MES workflows that ensure consistent manufacturing and product quality.

You will partner with engineering, quality, and leadership to implement data-driven improvements, lead RCCA investigations, develop dashboards, and drive manufacturing-readiness across the organization. All candidates must pass drug and background screening.