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Manufacturing Tech 2, Line 4 - Day Shift (C)

bioMerieux SA
Durham, NC Full Time
POSTED ON 2/27/2025
AVAILABLE BEFORE 4/24/2025

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 & Responsibilities:

The normal working hours for this role are 7:00am - 7:30pm (C Shift) working a 2-2-3 rotation schedule. The Manufacturing Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles in a cGMP compliant manner.

  • 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 product.
    • 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, utilize SOP and documentation to record data manually or through identified software applications.
    • Perform self-audit of rooms and processes
    • Train and certify teammates on production processes and procedures
  • 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
    • Work with other departments and 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
    • Attention to detail and the ability to accurately interpret technical documentation are critical
    • Perform computer applications including learning and execution of SAP transactions
    • Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and efficient production of all of our customer requirements
    • Other duties as assigned by manager

Education, Skills, & Experience:

  • High School Diploma or GED with 2 years of experience in a regulated production/operations environment
    • Equivalent military experience also accepted
    • BioWorks, LEAN or other Continuous Improvement Certificate, or an Associate’s Degree with 1 year of experience in a regulated production/operations environment also accepted
  • 4. 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 preferred.
  • Mechanical background preferred.
  • Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.
  • Ability to operate motorized pallet jacks or forklift.

Salary : $10,000

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