Aseptic Manufacturing Technician - All Shifts


Job Overview:

The Manufacturing Technician is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for commercial GMP manufacturing. The Manufacturing Technician will be responsible for the filtration and filling of a range of pharmaceutical products for clinical and commercial use.


  • Complete and maintain aseptic qualification training.
  • Obtain basic understanding of a task, unit operation and/or document (forms and/or SOPs) while aiding with oversight from Manufacturing Technician III and above.
  • Attain and maintain gowning qualification per appropriate SOPs.
  • Follow SOPs, product batch record instructions, logbooks and forms, and corresponding quality documentation in detail.
  • Prepare and maintain accurate documentation following cGMP and GDP principles.
  • Ensure documentations are completed in real-time in accordance to CGMP and GDP principles.
  • Adhere to all environmental, health, and safety policies and procedures and proactively identify unsafe conditions.
  • Support QC sampling, equipment calibration, equipment/utility validation, and preventive maintenance as needed.
  • Work collaboratively with internal teams to meet site goals and objectives as part of a team.
  • Initiate and foster a spirit of cooperation within and between departments.
  • Review documentation for accuracy, makes corrections and/or escalates to supervision/Manufacturing Quality Associate (MQA).
  • Maintain all personal cGMP related training in a current state.
  • Achieve and maintain cleaning and sanitization of cleanroom training. 
  • Participate in Aseptic media qualification per the appropriate qualification protocol.
  • Support manufacturing in the investigation of deviations and performs required risk assessments.
  • Participate in personnel monitoring as requested.
  • Work closely with Operational Excellence to identify and implement process improvements.
  • Set up and breakdown the filling equipment per appropriate SOPs.
  • Transport equipment and components as needed.
  • Interact with filling machines at the validated speeds and volumes.
  • Perform volume checks.
  • Perform and document inherent and non-inherent interventions.
  • Ensure slow and purposeful movements appropriate for a Grade A/B GMP aseptic environment.
  • Work with R&D and tech transfer team for successful transfer of Programs into the GMP area
  • Perform all aseptic connections, respecting first air.
  • Perform pre- and post-filter integrity testing as required.
  • Aseptically sterile filter products into appropriate vessels.
  • Complete routine and enhanced cleaning and sanitization of all controlled aseptic cleanrooms, as needed.
  • Attain and maintain ability to perform environmental tasks as required.
  • Perform other duties as assigned.


Physical Demands: 


Job Type : Full-Time
Experience Level : Entry Level
Job Function : Development
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