Manufacturing Tech 1, Line 4 – Night Shift Position Available In Durham, North Carolina

Benefits at bio

Merieux:

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 & Responsibilities:

Normal working hours: 7:00pm – 7:30am working a 2-2-3 rotation schedule. The Manufacturing Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles 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. + 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 Experience, Skills and Education:

+ High School Diploma/GED with 0+ years of relevant experience in a regulated production/operations environment + 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. + Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer #biojobs