Compliance & Improvement Engineer
BLD-50, 25212 W. Illinois Route 120 Round Lk Bch, IL 60073 US
JOB SUMMARY: Design, develop, integrate, test, evaluate or improve integrated systems or related processes, primarily with human factors, quality control, inventory control, and material flow, cost analysis, and production coordination. Must work with manufacturing personnel, quality, labs, supply chain, and site leadership to improve the quality and efficiency of processes, increase productivity and decrease costs. Must be able to evaluate quality data and develop programs and initiatives to ensure continued compliance to regulations and standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned:
- Take ownership of the management of SLT GEMBA process execution and subsequent action items, create communication and training materials for site operations personnel, Identify opportunities or implement changes to improve products or reduce costs. Drive site implementation of 65S with OpEx leaders
- Work with internal auditors to develop programs to ensure continued compliance with policies and regulations.
- Evaluate quality data and determine strategies, actions, and initiatives to drive improvements in the facility. Work with cross functional teams on implementation.
- Troubleshoot new or existing product problems involving human factors, materials, or processes. Provide technical expertise or support related to manufacturing.
- Confer with engineers or other personnel to implement operating procedures, resolve system malfunctions, or provide technical information.
- Determine root causes of failures using statistical methods and recommend changes in designs, tolerances, or processing methods.
- Perform nonconforming material analysis and create NCM reports. Work with Quality Control on reducing the NCMRs. -Plan and establish sequence of operations to fabricate and assemble parts or products and to promote efficient utilization.
- Read and interpret blueprints, technical drawings, schematics, or computer-generated reports. -Update documentation for job instructions, work instructions, and standard operating procedures. -Ensure safety procedures are followed, work areas are clean and maintained, and the department is following regulatory compliance requirements.
- Evaluate precision and accuracy of production and testing equipment and engineering drawings to formulate corrective action plan.
- Recommend design modifications to eliminate machine or system malfunctions.
- Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.
- Supervise the work of technicians and other associates as needed.
- Guide technical staff engaged in developing materials for specific uses in projected products or devices.
- Knowledge of cGMP and global regulatory guidelines such as EMA, FDA, and other health agencies.
- Knowledge of Six Sigma methodology and LEAN principles.
- Effective communicator at all levels; excellent written, oral, and interpersonal communication and presentation skills
- Experience with pharmaceutical and/or device quality and compliance management systems, desired.
- Hands-on experience in drug product aseptic manufacturing operations is desired, but not required.
Education and Experience
- At least 5 years of directly related experience within the pharmaceutical industry or medical device experience
- BS in Science or Engineering. Advanced degree a plus.
- Project management experience, preferred.
- Previous experience with due diligence, auditing, compliance management, or post-acquisition quality systems integration a plus
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