Manufacturing Tech - Durham, United States - Biofire Diagnostics

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 daily food stipend


Position Summary:
Normal working hours: 7:00pm - 7:30am working a 2-2-3

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.

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 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, & Experience:

• High School Diploma or GED Required with 0 years of experience required
• 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.