Manufacturing Technician

5 days ago


Durham, North Carolina, United States BioFire Diagnostics Full time
Job Summary:

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.

Key Responsibilities:

Operate high-speed manufacturing equipment, utilizing HMI/SCADA interfaces to execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs.

Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner, performing and documenting 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.

Requirements:

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.

What We Offer:

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, normal working hours for this role are 7:00am - 7:30pm working a 2-2-3 schedule.

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