Manufacturing Tech 1-Day Shift

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.

• 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.

• 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

• High School Diploma or 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.
  

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