bioMérieux is hiring a

Manufacturing Tech, Line 4 Filling - Day Shift C

Durham, United States
Full-Time
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: 7:00 am - 7:30 pm working a 2-2-3 schedule (C Shift).
 
The Process Technician position is responsible for operating high-speed equipment used in the production and packaging of BacT/ALERT bottles and/or preparing and formulating the liquid reagents that fill the finished BacT/ALERT bottle in a cGMP-compliant manner.    
  • The position may perform or assist in setting up, inspecting, performing preventive maintenance, troubleshooting, and cleaning equipment used throughout the BacT/ALERT Manufacturing and Packaging processes.
  • Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks
  • AQL inspections, reworks, and Material reconciliation that goes along with the batch.
Primary Responsibilities:    
  • Production:
    • Operate high-speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
    • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs
  • Quality:
    • Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner
    • Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations
    • Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of products.
    • Assist with manufacturing deviation analysis, CAPA actions, 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 cleaning equipment, and 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:
    • Generate reports, charts, and KPI's and interpret the data to identify problems, and proceed with proper decision-making
    • Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state
    • Perform computer applications
    • Perform other duties as assigned by Management
Knowledge, Skills, & Experience:    
  • High School Diploma or GED Required with 0 years of experience
  • Certification in a Bioworks Program or equivalent is preferred
  • Demonstrated proficiency in operating high-speed, highly automated, production equipment preferred.
  • Knowledge of and experience with following OSHA regulations (LOTO, electrical safety, etc.) preferred.
  • Knowledge of FDA and/or GMP regulations is preferred.
  • Mechanical background preferred.

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