Durham, NC, 27722, USA
5 days ago
Packaging Tech - 3rd Shift
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 normal working hours for this role are anticipated to be Monday - Friday from 11:00pm - 7:30am. 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. #biojobs
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