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Formulation Tech 2 - Day Shift

BioFire Diagnostics
Durham, NC Full Time
POSTED ON 1/21/2025
AVAILABLE BEFORE 4/21/2025

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 :

Normal working hours : 7 : 00am - 7 : 30pm working a 2-2-3 schedule.

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 Responsibilities :

  • Production :
  • Operate high speed manufacturing equipment, in some cases highly automated, using HMI / SCADA interfaces
  • 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
  • Operate cleaning 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 :
  • 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 2 years in a regulated production / operations environment
  • Associates Degree in an applicable or Technical field or Vocational / Technical School preferred
  • Formulation experience and background in bulking and / or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is highly desired
  • Familiarity with measurement scales, mixing, blending, chemical mills, and other formulation manufacturing equipment strongly desired
  • Certification in a Bioworks Program or equivalent is preferred
  • A basic chemistry and lab application experience 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.
  • Physical Requirements :

  • Ability to remain in stationary position, often standing, for prolonged periods.
  • Ability to ascend / descend stairs, ladders, ramps, and the like.
  • Ability to wear PPE correctly most of the day.
  • Ability to operate heavy machinery.
  • Ability to adjust or move objects up to 50 pounds in all directions.
  • biojobs

    Salary : $10,000

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