Position Summary:
Sr. Mechanical Engineer for highly automated packaging lines. The purpose of this role is to actively support packaging line engineering and maintenance activities and equipment for the bioMerieux, Inc. Durham Manufacturing Facility to produce cost effective quality product which meets all applicable regulatory standards and the needs of customers worldwide. This role will support and manage Equipment System design and development, specification documentation requirements, asset induction into CCMS, commissioning, qualification and validation activities and sustainability documentation such as Job Aids and troubleshooting guides, improvements and change management of existing equipment and commissioning of future equipment.
Primary Responsibilities:
- Subject Matter Expert for Commissioning, Qualification and Validation (CQV) Activities for design and start-up of an automated packaging line. This includes development and maintaining of validation plans and equipment lifecycle documents and development and execution of equipment CQV testing protocols.
- Collaborate with the Packaging Line equipment suppliers to establish Preventive Maintenance Schedules, Calibration Schedules, and Critical Spare Parts lists.
- Manage equipment systems and support system design specification documentation.
- Mechanical and electrical troubleshooting of specialized and highly automated process equipment.
- Develop Job Aids and Troubleshooting guides.
- Perform Root Cause Analysis for common equipment failures and implement corrective and preventative actions.
- Take an active role in the continuous improvement of departmental systems/infrastructure.
- Perform all work in compliance with company quality procedures and standards.
- Direct support of all packaging process equipment at the bioMerieux, Inc. Durham Manufacturing Facility.
- Be an active contributor to the Engineering Operations team.
- Support Packaging Line Project and Commercial Release to achieve production output goals.
- Review OEE results, analyze data, and implement improvements as required.
Education, Skills, & Experience:
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Bachelor’s degree in Engineering with a minimum of 5 years of experience in a manufacturing environment directly supported mechanical and production-level equipment & proficient in Commissioning, Qualification, and Validation processes.
- High School Diploma or GED with 10+ of experience in a manufacturing environment directly supported mechanical and production-level equipment & proficient in Commissioning, Qualification, and Validation processes also accepted
- AAS Degree with 7+ years of experience in a manufacturing environment directly supported mechanical and production-level equipment & proficient in Commissioning, Qualification, and Validation processes also accepted
- Project Management and Continuous Improvement experience required.
- 5+ years of experience working in a cGMP environment preferred.
- Experienced in high-speed, highly automated, production/packaging equipment preferred.
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