Manufacturing Tech 2, Line 4 - Night Shift (D)

• 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
  • Assess when manufacturing or quality issues require escalation to senior staff or management to promptly address potential impacts on business continuity.
  • Executing tasks accurately and efficiently is fundamental to meeting customer expectations and maintaining business continuity. Any disruptions in workflow directly impact production targets, affecting customer satisfaction and, ultimately, the company’s financial health.

• High School Diploma or GED Required with 2+ years of relevant experience in a regulated production/operations environment, OR Equivalent military experience, OR BioWorks, LEAN or other Continuous Improvement Certificate, or an Associate’s Degree with 1+ year 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.

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