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Night Shift Packaging Technician

2 months ago

Durham, United States Biomerieux 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 for this position is 7:00pm - 7:30am working a 2-2-3 schedule. The Packaging Technician is responsible for the operation of 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 the setup, inspection, preventive maintenance, troubleshooting, and cleaning of 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 the operation of high-speed, highly automated, production equipment preferred
  • Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred
  • Knowledge of FDA and/or GMP regulations is preferred
  • Mechanical background preferred

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