- 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.
- 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
- 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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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 a daily food stipend
Position Summary:
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:
Knowledge, Skills, & Experience:
