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Packaging Tech

2 months ago

Durham, United States BioFire Diagnostics 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 a daily food stipend

Position Summary:

Normal working hours for this position is 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

  • 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 products.

  • 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, and 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 0 years of experience

  • 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 is preferred.

  • Mechanical background preferred.

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