Skip to content

Job Openings

Compliance & Improvement Engineer

Round Lk Bch, IL 60073

Posted: 02/27/2023 Employment Type: Contract Job Category: Engineering Job Number: 546392 Is job remote?: No Country: United States

Job Description


Description

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.

Qualifications:
  • 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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

Wordpress Social Share Plugin powered by Ultimatelysocial