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Position Summary & Responsibilities:

The normal working hours are anticipated to be 2nd Shift: Monday - Friday from 3:00pm - 11:30pm. The Cleaning 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 cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.

+ 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

+ Safety

+ Comply with all safety policies and procedures at all times b. 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/GED with 0+ years of relevant experience in a regulated production/operations environment 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.

+ Ability to rapidly learn new procedures and reduce them to practice.

+ Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.

+ Reasonable, reliable attendance and punctuality is an essential job function required for this position. Ability to operate motorized pallet jacks or forklift.

+ Ability to remain to stand for long periods of time

+ Lifting, pushing, and pulling may be required for stocking and movement of equipment.

+ Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat.

+ Ability to work extended and/or overtime hours as required to support production operations

+ Must be able to push/pull objects up to 150lbs

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