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  • Associate Principal Process Engineer

    BioFire Diagnostics, LLC. (Hazelwood, MO)



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    The Associate Principal Process Engineer will work within the Reagent Engineering team as the lead point of contact for Sensor Manufacturing. Overall, this engineer will ensure day to day line performance is optimal, drive communication and cross functional troubleshooting / problem solving as needed, and work with Project / Materials Engineering in the development and execution of long term process optimization.

     

    PRIMARY DUTIES• Main accountability is to act as the lead point of contact within Engineering for Sensor, working with manufacturing, line maintenance, and quality personnel to monitor and optimize area performance. • Lead the communication of ongoing issues to the management team and assist in driving to resolutions through the use of cross functional support, providing equipment expertise as needed routing troubleshooting. • Leverage data to assess equipment, personnel and material interactions with the area of ownership in order to enhance efficiency, reduce waste, minimize cost, and enhance safety. • Assist in the management and development of engineering and compliance related documentation throughout the equipment lifecycle / change control process, acting as lead for the execution of validation protocols attributed to area of ownership.• Participate in cross functional teams to drive root cause analysis and quality event investigations, as well as corrective actions and preventative measures attributed to area of ownership. • Assist in the development and administration of training and guidance to manufacturing, line maintenance, and quality on new processes, procedures and equipment to ensure successful implementation and operation. • Work with Project / Materials Engineering in the development of long-term strategies for equipment and process improvements.

     

    POSITION REQUIREMENTS- High School Diploma and 10+ years of experience with mechanical troubleshooting, diagnostics, data analysis and/or validation- Technical Certification / Associates Degree and 8+ years of experience with mechanical troubleshooting, diagnostics, data analysis and/or validation- Bachelors Degree and 6+ years of experience with mechanical troubleshooting, diagnostics, data analysis and/or validation- Masters Degree and 4+ years oexperience with mechanical troubleshooting, diagnostics, data analysis and/or validation• Project Management experience is preferred. • Ability to collaborate professionally in a cross-functional team environment.• Knowledge of FDA/ISO regulations and equipment validation is preferred. • Strong Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook).• Must have strong communication and interpersonal skills.• Must have strong analytical and problem-solving skills.

     

    WORKING CONDITIONSLaboratory with exposure to chemicals PHYSICAL REQUIREMENTSExtensive standing, repetitive hand and arm motions, ability to climb steps.Lifting (up to 50Lbs) and moving containers of cartons, tubes, and printed materials.Must be able to push a wheeled cage that can weigh up to 600 lbs fully loaded. Operating within cool temperature and low humidity conditions within the production room. Constant noise is common due to the operation of the air-dry chamber, taping and pouching equipment. Excellent personal hygiene required. Appropriate gowning requirements necessary for the production areas. Gloves are required to handle the product. Hairnet, clean room gowns and/or lab coats are required. Safety glasses and hearing protection are required personal protective gear. Occasional environmental odors may be prevalent.

     


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