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BioFire Diagnostics, LLC. Formulation Tech 2 - Night Shift in Durham, North Carolina

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.

    #biojobs

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