Manufacturing Tech 1 - 2nd Shift

Durham, North Carolina

Employer: bioMérieux SA
Industry: Manufacturing
Salary: Competitive
Job type: Part-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 daily food stipend


Position Summary:

The Process Technician position 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 Duties:
  • Production
    • Manufacturing & Packaging: Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
    • Formulation: chemical weighing and reagent formulation
    • 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
  • 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, and Experience:
  • Education & Experience
    • High School Diploma or GED Required
    • Minimum of 0-1 years in a regulated production/operations environment
  • Skills
    • Certification in Bioworks Program preferred
    • For Manufacturing and Packaging:
      • Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.
    • For Formulation:
      • Background in Bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired.
      • Familiarity with measurement scales, mixing, blending, chemical mills and other formulation manufacturing equipment strongly desired.
    • Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
    • Knowledge of FDA and/or GMP regulations preferred.
    • Mechanical background preferred.
    • Ability to rapidly learn new procedures and reduce them to practice.
    • Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.


Job ID: 40275

Nearest Major Market: Durham
Nearest Secondary Market: Raleigh
Created: 2024-06-30
Reference: 154821452
Country: United States
State: North Carolina
City: Durham
ZIP: 27703

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