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Process Engineer

3 months ago

Lakewood, United States Medix Full time

Responsibilities:

Process and Equipment Design:

  • Evaluate existing processes and configure manufacturing equipment to reduce costs and improve sustainability.
  • Define and specify cGMP process equipment, piping, and controls to enhance process capability and production volume while maintaining quality standards.
  • Assist in the design review, site acceptance, and installation of equipment.

Troubleshooting and Maintenance:

  • Ensure overall reliability of automated manufacturing lines and troubleshoot equipment issues in a fast-paced environment.
  • Develop solutions to prevent downtime for filling and packaging lines and lead implementation of changes.

Process Improvement:

  • Develop and improve existing processes and methods for control and troubleshooting of manufacturing technical problems.
  • Propose and implement operational efficiency improvements utilizing Lean principles.
  • Conduct engineering trials, prepare reports, and present findings.

Documentation and Compliance:

  • Prepare project documents including scopes, conceptual designs, capital requests, specifications, P&IDs, schedules, RFQs, expenditures, procedures, and cost estimates.
  • Support QA and Validation departments by preparing design documents and assisting in protocol generation and execution.
  • Prepare change control documentation and write/modify procedures for proper operation of new/existing equipment.
  • Ensure safety requirements are integrated into the processes.

Project and Personnel Management:

  • Support Sr. Manager in research and purchase of new manufacturing technology and equipment.
  • Ensure projects are completed on time and within financial budgets.
  • Assist with training of operations and maintenance personnel as needed.
  • May supervise mechanical, electrical, and automation contractors as well as maintenance mechanics, contract engineers, and construction contractors.

Experience Requirements:

General:

  • 3 to 5 years of experience in designing processes and equipment for pharmaceutical manufacturing.
  • Experience with aseptic filling is a plus.

Technical:

  • Proven ability to troubleshoot filling and packaging line issues related to equipment, materials, and quality.
  • Experience in improving production rates, efficiencies, yields, costs, and changeovers.
  • Ability to work on off-shifts to support a 3-shift operation.

Educational Requirements:

  • B.S. degree in Chemical, Biochemical, Equipment, or Mechanical Engineering is required.
  • Three years of relevant experience in the pharmaceutical industry is preferred.

This role demands a blend of engineering expertise, hands-on problem-solving skills, and a solid understanding of pharmaceutical manufacturing processes, especially in ensuring equipment reliability and optimizing production efficiency. The ideal candidate will have a strong background in cGMP, lean principles, and the ability to manage complex projects and troubleshoot technical issues effectively.