Manufacturing Tech 2, Line 4 - Day Shift (C)
BioFire Diagnostics, LLC.
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 & Responsibilities:
The normal working hours for this role are 7:00am - 7:30pm (C Shift) 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.
+ 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.
+ 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
+ Attention to detail and the ability to accurately interpret technical documentation are critical
+ Perform computer applications including learning and execution of SAP transactions
+ 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
+ Other duties as assigned by manager
Education, Skills, & Experience:
+ High School Diploma or GED with 2+ years of experience in a regulated production/operations environment
+ Equivalent military experience also accepted
+ BioWorks, LEAN or other Continuous Improvement Certificate, or an Associate’s Degree with 1 year of experience in a regulated production/operations environment also accepted
+ 4. 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.
+ Ability to operate motorized pallet jacks or forklift.
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