Manufacturing Cleaning Tech 1 - 3rd Shift

Description

Position Summary & Responsibilities:

The normal working hours for this role are 3rd shift: 11:00pm - 7:30am Monday - Friday. 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 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
  

Education, Skills, & Experience

• 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.
• 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.
• Physical Requirements:
• Excellent personal hygiene required.
• Ability to remain to stand for long periods of time
• Lifting, pushing, and pulling may be required for stocking and movement of equipment.
• May be exposed to Static De-ionizing bars and require individuals with pacemakers to remain 21 inches away
• May be exposed to Chemical Hazards and require the handling of chemicals, antibiotics and/or hazardous materials.
• May be exposed to strong odors incurred during media production or other operations.
• 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.
• The job utilizes equipment and processes which include mechanical hazards, electricity hazards, and tripping / falling hazards.
• Must be able to push/pull objects up to 150lbs
  

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