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Formulation Tech 2

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 daily food stipend

Position Summary:
Normal working hours: 7:00pm - 7:30am working a 2-2-3 rotation. 

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.
    • 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
    • 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
    • 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
    • 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
  • Certification in a Bioworks Program or equivalent is preferred
  • A basic chemistry and lab application experience strongly desired 
  • 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.

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.

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