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Aseptic Filling Technician 1st Shift

Grifols
Full-time
On-site
North Carolina, United States
Operations

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Role Summary

Aseptic Filling Technician 1st Shift

Responsibilities

  • Tech I/II: Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals
  • Class A/B gowning qualified for facility cleaning of fill suites
  • Operate support fill equipment such as the glass inspection stations, rinser/tunnel, VAM and over sealer. Load carts with vials or syringes
  • Perform SIP/PBC Operations and filter integrity testing
  • Prepare chemical solution for production use. Strict adherence to Dept. Safety Rules.
  • Perform material handling and glass inspection activities
  • Detailed, general facility housekeeping i.e. minor cleaning, keeping work and production area neat and free from clutter
  • Cleaning - Sanitization per procedures, documentation of sanitization, mopping, disinfecting (floors, walls, equipment)
  • Operate motorized transport equipment for moving supplies
  • Real time documentation during production run and maintain accurate records/logs
  • Monitor and operate various computer control systems for production activities
  • Tech II: Performs all duties described at the Technician level
  • Fill room qualified with the ability to setup and operate fill equipment independently in an aseptic environment
  • Demonstrates department specific aseptic techniques and capabilities
  • May operate and monitor final container lyophilization, heat treatment, pasteurization, and cold box
  • Operate filter integrity tester
  • Prepares and properly labels samples according to BPR and non-routine requests
  • Independently interprets and utilizes information from company support systems
  • Assist with initial training responsibilities for the Technician level
  • Trains less experienced Technicians in the use of applicable computer systems
  • Maintain aseptic gowning qualification and media fill certification

Qualifications

  • High School diploma OR GED required
  • One year of regulated industry experience OR Graduation from an accredited college/university with an Associateโ€™s or Bachelorโ€™s degree OR Completion of the Bioworks Certification Program preferred
  • Tech II: typically requires one year of experience as an Aseptic Filling Technician

Knowledge, Skills & Abilities

  • Good math and mechanical aptitude with ability to perform in an aseptic environment
  • Production work experience in a high-volume manufacturing environment is desired
  • Ability to function in an aseptic environment while maintaining product sterility
  • Ability to work effectively as a team member
  • Ability to lift up to 50 pounds; continuous standing, walking and some bending
  • Off shift and overtime work may be necessary

Education

  • Not specified beyond the Qualifications section