Aseptic Fill Specialist – 3rd Shift, Cleanroom Champion

FUJIFILM Biosciences; Santa Ana (CA); Sur place; USD 33 000 - 43 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Résumé du poste

FUJIFILM Biosciences is hiring an Aseptic Filing Tech for third shift (9:00pm–5:30am) in Santa Ana, CA. The role focuses on sterile filtration, filling, and sterilizing filters, containers, and closures in a cleanroom environment.

The position requires experience with aseptic filling systems, ISO 5 cleanroom gowning, and a solid GMP understanding. Base pay ranges from $24.17 to $31.42 per hour, plus medical, dental, vision, life insurance, 401k, and PTO.

Qualifications

• High School Diploma or equivalent.
• Minimum one year as certified aseptic filling technician.
• Experience with manual and automated aseptic fill systems.
• Certification in ISO 5 environment cleanroom gowning.
• Good work history.
• Knowledge of metric system and its unit conversions.
• Knowledge of aseptic techniques.
• General understanding of GMPs.
• Ability to speak, read, and write English.

Responsabilités

• 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.
• Perform cleanroom support tech activities—includes room/station set up and 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.
• Follow 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 PPE.
• 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 SOPs.
• Other duties as assigned by Lead or Supervisor.

Connaissances

Aseptic filling

Cleanroom procedures

GMP knowledge

English proficiency

Formation

High School Diploma

Certified aseptic filling tech

Outils

Aseptic filling equipment

Sterilization equipment

Description du poste

FUJIFILM Biosciences is hiring an Aseptic Filing Tech for third shift (9:00pm–5:30am) in Santa Ana, CA. The role focuses on sterile filtration, filling, and sterilizing filters, containers, and closures in a cleanroom environment.

The position requires experience with aseptic filling systems, ISO 5 cleanroom gowning, and a solid GMP understanding. Base pay ranges from $24.17 to $31.42 per hour, plus medical, dental, vision, life insurance, 401k, and PTO.