Manufacturing Tech, Line 4 Filling - Day Shift C

Manufacturing Durham, North Carolina

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Description

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: 7:00 am - 7:30 pm working a 2-2-3 schedule (C Shift).
 
The Process Technician position is responsible for operating 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 setting up, inspecting, performing preventive maintenance, troubleshooting, and cleaning 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 operating high-speed, highly automated, production equipment preferred.
  • Knowledge of and experience with following OSHA regulations (LOTO, electrical safety, etc.) preferred.
  • Knowledge of FDA and/or GMP regulations is preferred.
  • Mechanical background preferred.

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BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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