Aseptic Filling Technician - 3rd Shift

Fujifilm•Santa Ana, CA
•$24 - $31•Onsite

About The Position

FUJIFILM Biosciences is hiring an Aseptic Filling Technician responsible for sterile filtration and filling, and sterilizing filters, containers, and closures. This is a third-shift position from 9:00 p.m. to 5:30 a.m. The technician prepares and sets up aseptic filling and filtration equipment in a cleanroom environment and uses manual or automated filling systems for liquid media products. The role includes following cleanroom gowning and behavior procedures, disinfecting controlled and support environments, completing filter integrity tests, and performing room and equipment cleaning. The technician also supports room, station, and batch setup; stages containers and components; collects and labels QC samples; manages supplies and batch-related inventory transactions; and completes accurate, timely documentation using electronic documentation systems. Work must follow SOPs, line-clearance requirements, cGMP and cGLP practices, safety procedures, and 6S principles. The company describes its work as supporting life-sciences research and biopharmaceutical development through products and services in areas including cell culture media, research reagents, proteins, and assay materials.

Requirements

  • High school diploma or equivalent.
  • At least one year of experience as a certified aseptic filling technician.
  • Experience with both manual and automated aseptic filling systems.
  • Certification in ISO 5 environment cleanroom gowning.
  • Good work history.
  • Knowledge of the metric system and unit conversions.
  • Knowledge of aseptic techniques.
  • General understanding of Good Manufacturing Practices (GMPs).
  • Ability to speak, read, and write English.
  • Good oral and written communication skills.

Responsibilities

  • Prepare and set up aseptic filling and filtration equipment in a cleanroom environment.
  • Use manual or automated filling systems to fill liquid media products while following aseptic-filling procedures.
  • Follow cleanroom behavior and gowning procedures.
  • Disinfect controlled cleanroom and formulation areas, CNC areas, and support environments in compliance with SOPs.
  • Perform cleanroom support activities, including room or station setup and associated batch setup.
  • Maintain complete and accurate documentation for work performed and navigate the electronic documentation system.
  • Complete transactions for batch components and supplies to maintain inventory accuracy.
  • Follow line-clearance requirements and maintain cGMP and cGLP in work areas.
  • Follow safety procedures and wear required personal protective equipment.
  • Clean rooms and equipment according to current procedures and maintain an organized cleanroom using 6S principles.
  • Keep designated cleanroom supplies stocked and order additional supplies or notify the Lead or Supervisor when they are needed.
  • Complete filter integrity testing in a timely manner.
  • Perform container and component staging as needed.
  • Obtain and label QC samples as required.
  • Complete filling documentation in a timely manner.
  • Suggest changes to departmental SOPs.
  • Perform other duties as assigned by the Lead or Supervisor.

Benefits

  • Medical, dental, and vision coverage.
  • Life insurance.
  • 401(k).
  • Paid time off.
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