Description

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 interfacesExecute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs QualityEnsure that all batch paperwork is completed in an accurate, thorough, and timely mannerPerform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulationsProvide 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 concernsMaintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirementsSafety
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 makingAssist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated statePerform computer applicationsPerform 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 preferredDemonstrated 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 timeLifting, 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 operationsMust be able to push/pull objects up to 150lbs

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