• Manufacturing Tech 1-Night Shift

    BioFire Diagnostics, LLC. (Durham, NC)


    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.

    Responsibilities:

    + 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

    + 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.

    + 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

    Education, skills and experience:

    + High School Diploma or GED

    + Minimum of 0 years of relevant experience in a regulated production/operations environment

    + 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.

    + 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.