Sr Mechanical Engineer
Location: Durham, NC, United States
Position Type: Unfixed Term
Job Function: Manufacturing
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A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description
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:
- 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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Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at
BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at , or by dialing 711 for access to Telecommunications Relay Services (TRS).
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