Manufacturing Process & Operational Excellence Lead
CBG Biotech
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Benefits offered by this job
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
Education
Tools
Job description
CBG Biotech is a leading innovator in the design and manufacture of advanced solvent recycling equipment at our Solon, Ohio facility. Founded with a mission to make a positive impact on the world, we help laboratories, universities, and industrial organizations reduce their carbon footprint through sustainable resource recovery. Since 1995, we've partnered with leading institutions to improve efficiency, minimize waste and advance environmental responsibility. As we expand our product portfolio, we're looking for passionate professionals to join our growing team and drive innovation forward. Learn more at www.cbgbiotech.com.
CBG Biotech is seeking an experienced Manufacturing Process & Operational Excellence Lead to develop, implement, and maintain the systems that support consistent manufacturing, product quality, and operational execution. This is a hands-on, individual-contributor role responsible for building manufacturing processes, routings, and MES workflows, and the SOPs, BOMs, and drawings that keep them accurate -- alongside the quality controls, corrective-action systems, and dashboards that measure whether they're working. You'll work directly with engineering, manufacturing, quality, service, and leadership to identify process gaps, build practical solutions, and verify those systems are followed and producing measurable results. This role is ideal for someone who enjoys creating structure, organizing technical information, analyzing data, and personally driving projects through completion.
- Develop manufacturing processes, routings, operation sequences, labor standards, and production requirements.
- Lead implementation and continued development of Manufacturing Execution System (MES) processes.
- Define how production employees access instructions, record work, document inspections, and complete manufacturing 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 improved tooling, fixtures, mistake-proofing, and workstation organization.
- Support new product introduction and production-readiness activities.
- Develop, document, and maintain manufacturing and operational SOPs.
- Convert existing employee knowledge and informal practices into controlled, repeatable processes.
- Create work instructions, checklists, process maps, forms, inspection criteria, and training materials.
- Establish document ownership, review periods, revision control, and approval requirements.
- Train employees on newly implemented processes and verify ongoing compliance.
- Review existing processes to eliminate unnecessary steps, unclear responsibilities, and undocumented work.
- Develop, review, and maintain accurate manufacturing BOMs.
- Coordinate the creation, revision, approval, and release of engineering and manufacturing drawings.
- Ensure consistency between drawings, BOMs, routings, work instructions, and physical product configurations.
- Support Engineering Change Order implementation and verify approved changes are incorporated into all affected systems and documents.
- Establish controls for product revisions, substitutions, obsolete components, and approved deviations.
- Resolve discrepancies between design documentation and actual manufacturing practices.
- Lead and facilitate structured root-cause and corrective-action (RCCA) investigations.
- Maintain a centralized RCCA and corrective-action tracker.
- Assign action owners, target dates, containment requirements, and effectiveness checks.
- Apply problem-solving methods such as 5-Why, fishbone analysis, and Pareto analysis.
- Follow up on overdue actions and elevate unresolved corrective actions.
- Verify completed actions prevent recurrence rather than only addressing the immediate problem.
- Connect RCCA findings to SOP revisions, design changes, training, or manufacturing-process improvements.
- Define and collect meaningful manufacturing and quality data.
- Develop dashboards and recurring reports for leadership and process owners.
- Trend nonconformances, inspection failures, rework, scrap, supplier issues, and corrective actions.
- Use Pareto charts and other analytical methods to identify the largest sources of quality and operational problems.
- Establish clear definitions and consistent data-entry practices so reported metrics are reliable.
- Present findings, recommended priorities, and action status during operational and quality reviews.
- Provide technical and process oversight for incoming, in-process, and final inspection.
- Develop inspection plans, acceptance criteria, sampling requirements, and inspection documentation.
- Ensure inspectors have access to current drawings, specifications, procedures, and acceptance standards.
- Establish appropriate inspection hold points throughout the manufacturing process.
- Improve documentation and disposition of nonconforming material.
- Monitor inspection effectiveness, recurring defects, and process compliance.
- Support inspector training and competency development.
- Develop and maintain a consistent case-management process for technical, quality, manufacturing, and customer-service issues.
- Establish requirements for case intake, categorization, prioritization, ownership, escalation, and closure.
- Ensure cases contain sufficient technical documentation, troubleshooting history, findings, and resolution information.
- Analyze case data to identify recurring product, manufacturing, supplier, or process issues.
- Develop metrics for case age, closure time, recurring issues, and corrective-action effectiveness.
- Support production planning and scheduling process improvements.
- Assist with supplier-quality and incoming-material issues.
- Participate in new product introduction and product-validation activities.
- Support internal audits and future quality-system certification efforts.
- Coordinate employee training related to manufacturing and quality processes.
- Support safety, compliance, and continuous-improvement initiatives.
- Work with leadership to prioritize and complete operational improvement projects.
- Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, or a related discipline.
- Five or more 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 and maintaining 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 incoming, in-process, and final inspection practices.
- Ability to interpret engineering drawings and technical specifications.
- Strong Excel and data-analysis capabilities; experience with Power BI or similar dashboard software is highly desirable.
- Familiarity with ISO 9001, AS9100, or another formal quality-management framework is strongly preferred.
- Experience in low-volume, high-mix, engineered-product manufacturing is preferred.
- Strong project-management, communication, documentation, and follow-through skills.
CBG Biotech offers competitive salary, Paid Time Off, Life/Medical/Dental/Vision/Disability insurances and 401K match. Flexible work week: 9 hour workday M-Th + 4 hour workday on Friday!
All candidates must pass drug and background screening.
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