Jobs · Engineering · California

Aseptic Filling Technician - 3rd Shift

FUJIFILM Biosciences · Santa Ana, CA · 2 wk ago
On-siteEngineering$24.17–$31.42/hrFull-time

Responsibilities

  • Prepare and set-up aseptic filling/filtration equipment in a cleanroom environment.
  • Follows Aseptic-filling procedures while using manual or automated filling systems to fill various liquid media products.
  • Follows proper cleanroom behavior and gowning procedures.
  • Ability to disinfect controlled (cleanroom, formulation) areas, controlled not certified (CNC) and support environments in compliance with SOP.
  • Performs cleanroom support tech activities- includes but not limited to room/ station set up and associated batch set up.
  • Maintains and ensures completeness and accuracy of all documentation associated to work performed.
  • Ability to navigate through electronic documentation system.
  • Responsible for transactions associated with components and supplies used for batch; to maintain inventory accuracy.
  • Follows line clearance requirements to maintain cGMP and cGLP in all work areas.
  • Follows all safety procedures and works in a safe manner including wearing all required personal protective equipment.
  • Performs room and equipment cleaning per current procedures.
  • Maintains the cleanroom in an organized fashion following 6S principles.
  • Ensures that required supply items such as gloves, wipes, alcohol, etc. are well stocked in their designated areas of the cleanroom.
  • Responsible for ordering additional supplies or informing the Lead or Supervisor that additional supplies are needed.
  • Completes filter integrity testing in a timely manner.
  • Ensures that all cleaning procedures are properly followed.
  • Performs container/component staging as needed.
  • Obtains and labels QC samples as required.
  • Completes necessary filling documentation in a timely manner.
  • Suggests changes in departmental Standard Operating Procedures (SOPs).

Qualifications

  • High School Diploma or equivalent.
  • Minimum one year as certified aseptic filling technician.
  • Experience must include manual and automated aseptic fill systems.
  • Certification in ISO 5 environment cleanroom gowning.
  • Good work history.
  • General education (High School level) Knowledge of metric system and its 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.

Benefits

  • Medical
  • Dental
  • Vision
  • Life Insurance
  • 401k
  • Paid Time Off

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