Senior Mechanical Engineer for Automated Systems

2 weeks ago


Durham, North Carolina, United States BioFire Diagnostics Full time

Position Overview:

As a Senior Mechanical Engineer, you will play a crucial role in the engineering and maintenance of highly automated packaging systems. This position is essential for ensuring that our manufacturing facility produces high-quality products that comply with all relevant regulatory standards and meet global customer needs.

Key Responsibilities:

  • Act as a Subject Matter Expert for Commissioning, Qualification, and Validation (CQV) activities related to the design and implementation of automated packaging lines, including the development and maintenance of validation plans and lifecycle documentation.
  • Collaborate with equipment suppliers to create and maintain Preventive Maintenance and Calibration schedules, as well as Critical Spare Parts inventories.
  • Oversee the design specifications and documentation for equipment systems.
  • Conduct mechanical and electrical troubleshooting on specialized, highly automated process equipment.
  • Develop comprehensive Job Aids and Troubleshooting guides to support operational efficiency.
  • Perform Root Cause Analysis on frequent equipment failures and implement corrective and preventive measures.
  • Engage actively in the continuous improvement of departmental systems and infrastructure.
  • Ensure all work adheres to company quality standards and procedures.
  • Provide direct support for all packaging process equipment within the manufacturing facility.
  • Contribute effectively to the Engineering Operations team.
  • Support Packaging Line Projects and Commercial Releases to meet production output objectives.
  • Analyze OEE results and data to identify and implement necessary improvements.

Qualifications:

  • Bachelor's degree in Engineering with a minimum of 5 years of experience in a manufacturing setting, specifically with mechanical and production-level equipment, and proficiency in CQV processes.
  • High School Diploma or GED with 10+ years of relevant experience is also acceptable.
  • AAS Degree with 7+ years of experience in a similar environment is also considered.
  • Experience in Project Management and Continuous Improvement is required.
  • Preferred: 5+ years of experience in a cGMP environment.
  • Preferred: Experience with high-speed, highly automated production and packaging equipment.


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