Mechanical Engineer

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux 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 5,000 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.

Position Summary:

Mechanical Engineer for a new highly automated manufacturing line project (Line 5). The purpose of this role is to actively support of all Line 5 engineering and maintenance activities and manufacturing 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, and sustainability documentation such as Job Aids and troubleshooting guides through Line 5 Commercialization.

Responsibilities:

• Perform all work in compliance with company quality procedures and standards.
• Manage Line 5 equipment systems and support system design specification documentation.
• Direct support of all manufacturing process equipment at the bioMerieux, Inc. Durham Manufacturing Facility.
• Manage installation, shakedown, and start-up of new manufacturing equipment.
• Support Line 5 Facility Acceptance Testing, Site Acceptance Testing, IOQ through Process Validation.
• Manage installation, shakedown, and start-up of new manufacturing equipment.
• Develop Job Aids and Troubleshooting guides.
• Collaborate with the Line 5 equipment suppliers to establish Preventive Maintenance Schedules, Calibration Schedules, and Critical Spare Parts lists.
• Performing preventive/corrective maintenance activities.
• Mechanical and/or electrical troubleshooting of specialized and highly automated process equipment.
• Champion failure root cause analysis.
• Take an active role in the continuous improvement of departmental systems/infrastructure.  
• Be an active contributor to the Engineering Operations and Production Maintenance team. 
• Maintain production equipment to perform as designed.
• Support Line 5 Project and Commercial Release to achieve production output goals.

Studies and Experience:

• High School Diploma/GED with a minimum 7 years of technical experience focused on support of mechanical/production level equipment required.
• Bachelor’s degree with a minimum 3 years of technical experience focused on support of mechanical/production level equipment preferred.
• Minimum 3 years of Project Management and Continuous Improvement experience required.
• Minimum 3 years of experience working in a cGMP environment preferred.
• Experienced in the operation of high speed, highly automated, production equipment preferred.
• Commissioning, Qualification, and Validation activities experience preferred.
• Strong background in reading ladder logic, troubleshooting and repairing PLC(s), electrical systems, AC/DC drive systems, and mechanical systems preferred. 
• Proficiency in machining, welding, and fabricating preferred.

Skills and Qualifications:

• Demonstrated ability to exercise leadership, diplomacy, and problem solving skills when coordinating and working within all levels of the organization.
• Basic Computer Skills required; must be experienced and proficient in the use of:
  1. Basic Microsoft Office tools (specifically Word & Excel).
• Excellent documentation and communication skills (written & verbal).
• Strong attention to detail and GMP experience (including knowledge of change control, validation, and commissioning processes.)
• Ability to work successfully autonomously, as an active contributor on a team/shift.
• Demonstrated leadership behaviors and skills and willingness to work towards driving improvement within and external to the department, as a Maintenance & Reliability team representative.  Ability to act as a team leader when required.
• Experienced with equipment change control and standard operation procedures (generation/revision).
• Demonstrating the behaviors of being a self-starter who is organized, detailed, conscientious, and ambitious.  Lead by example.
• Models behaviors such as being a team player with a positive attitude, approaching projects/tasks with a sense of ownership, and developing and improving the skill level and behaviors of others.
• Performs documentation requirements in a cGMP compliant manner in accordance with Quality Policies.
• Responsible to follow all site Safety Policies/OSHA policies including requirements as related to personal protection equipment as needed to perform routine and non-routine duties.
• Takes an active / leading role in continuous equipment improvement as well as infrastructure improvement toward the implementation of sustainable reliability based maintenance program.
• Ability to work effectively as part of a team in addition to autonomously as required.
• Effectively communicates within team and interfaces with other site departments, verbally and written.
• High level understanding of equipment, processes and products.
• Ability to maintain and execute a Project Schedule.

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.