Durham, NC, 27722, USA
8 days ago
Formulation Tech 2 - 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. 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 + Chemical weighing and reagent formulation + 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. + Perform self-audit of rooms and processes + Train and certify teammates on production processes and procedures + 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 + Work with other departments and 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 + 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 + Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and efficient production of all of our customer requirements + Perform other duties as assigned by Management Knowledge, Skills, & Experience: + High School Diploma or GED Required with 2+ years in a regulated production/operations environment + Associates Degree in an applicable or Technical field or Vocational / Technical School preferred + Certification in a Bioworks Program or equivalent is preferred + A basic chemistry and lab application experience strongly desired + Background in bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired + Familiarity with measurement scales, mixing, blending, chemical mills, and other formulation manufacturing equipment strongly desired + Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. Physical Requirements: + Ability to remain in stationary position, often standing, for prolonged periods. + Ability to ascend/descend stairs, ladders, ramps, and the like. + Ability to wear PPE correctly most of the day. + Ability to operate heavy machinery. + Ability to adjust or move objects up to 50 pounds in all directions. #biojobs
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