Durham, NC, 27722, USA
8 days ago
Manufacturing Tech - Night 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 daily food stipend Position Summary: Normal working hours: 7:00pm - 7:30am working a 2-2-3 rotation schedule. 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. #biojobs
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