Manufacturing Technical Lead, Line 4 - Day Shift

Manufacturing Durham, North Carolina


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Description

Benefits at bioMerieux:
Low-cost medical, dental, and vision benefits starting day one

11 paid holidays
160 hours of paid time off
Annual bonus
9.5% 401k company contribution with no vesting period
Tuition reimbursement up to $10,000 per calendar year
Onsite cafeteria with a daily food stipend   
   
Position Summary:   
Normal working hours will be 7:00am - 7:30pm working a 2-2-3 schedule   
The Line 4 Technical Lead position is responsible for front line troubleshooting, process improvement oversight / execution, basic to intermediate maintenance, and as needed operation of high speed equipment used in the production of BacT/ALERT bottles in a cGMP compliant manner.   
Primary Responsibilities:  
  • Production:
    • As on shift Tech Lead, responsible for front line troubleshooting of high-speed equipment
    • Identify, implement, and train on best operational and on-floor maintenance practices. 
    • Serve as liaison between Manufacturing Technicians and supporting departments. 
    • Operate and maintain highly automated bottle handling, filling, vision inspection, conveying, or process batching equipment in a cGMP compliant manner, using HMI/SCADA interfaces. 
    • Setup high speed manufacturing equipment, vision systems and barcoding equipment within defined tolerances, to ensure product runs are started on time and within established guidelines. 
    • Check equipment during production runs for proper performance and assures manufacturing management is maintaining standard speeds. 
    • Troubleshoot moderate to significant equipment related issues. 
    • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs to support manufacturing, maintenance history records and training requirements. 
  • Maintenance:
    • Perform basic to intermediate maintenance and support major maintenance and PM activities.
    • Train Manufacturing teams on basic to intermediate equipment and maintenance intervention.
    • Partner with maintenance and calibration staff to perform routine and preventative maintenance activities to include inspecting, lubricating, adjusting of manufacturing equipment in a timely basis to ensure reliability and minimize the incidence of unplanned downtime to production equipment.
    • Read and interpret Blue Prints and Schematic Drawings.
    • Monitor production output and make adjustments as needed to increase product output.
    • Make adjustments to equipment such as vacuum adjustments, correction factors, ratio checks, MFM, MDP, conveyor speeds and Gaylord conveyor.
    • Perform maintenance activities such as clearing jams, cleaning degasser transducers, AP nozzles/valves and replacing degasser cup seals.
    • Assist Maintenance with troubleshooting/repairs as needed.
    • Perform Maintenance Focused Math and Measurements.
    • Monitor scrap rates and make or suggest adjustments as needed to reduce scrap.
  • Quality: 
    • Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner.
    • Perform technical writing as it relates to Preventive Maintenance SOPs, Training SOPs and Technical Documentation.
    • Assist with manufacturing deviation analysis, CAPA actions, CERs, EOOSs and other process equipment related quality concerns.
    • Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements.
    • Operate equipment, utilize SOP and documentation to record data manually or through identified software applications.
  • Safety: 
    • Comply with all safety policies and procedures at all times
    • Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties
  • Other Duties:
    • Serve as back up to Manager or Sr. Manager in technical discussions as needed
    • Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making
    • Work with other departments and assist with executing validation protocols associated with manufacturing equipment and procedures
    • Accurately interpret technical documentation.
    • Perform computer applications including learning and execution of asset management system.
    • Leverage statistical process software to maintain optimal process centering.
    • Make real-time decisions which have significant impact on production output.
    • Identify and train personnel on operational and maintenance best practices.
    • Propose changes to Manufacturing or Maintenance procedures, processes, or drawings.
Education, Skills, & Experience:   
  • High school diploma or GED with 7 years of experience in production environment operating and/or maintaining high speed automated equipment OR
    • Associates Degree in an applicable or Technical field or Vocational / Technical School & 6 years experience production environment and /or maintenance & repair

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BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. 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 BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).