Aseptic Filling Technician - Cleanroom 2nd Shift

FUJIFILM Holdings America Corporation; Irvine (CA); On-site; USD 33,000 - 43,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences in California is seeking an Aseptic Filing Tech for the 2nd shift (1:00pm–9:30pm) in Irvine. You will operate sterile filtration and filling equipment in a cleanroom and follow strict SOPs to ensure product integrity.

Key duties include equipment set-up, routine disinfection, sample labeling, accurate documentation, line clearance, and maintaining 6S in the cleanroom while upholding cGMP/cGLP standards and workplace safety.

Qualifications

• Requires high school diploma or equivalent.
• At least one year as certified aseptic filling technician.
• Experience with manual and automated aseptic fill systems.
• Certification in ISO 5 cleanroom gowning.
• Solid understanding of GMPs.
• Ability to read, write, and speak English.
• Excellent written and verbal communication skills.

Responsibilities

• Prepare and set-up aseptic filling/filtration equipment in a cleanroom environment.
• Follow aseptic filling procedures using manual or automated systems.
• Maintain proper cleanroom behavior and gowning.
• Disinfect controlled areas following SOPs and document activities.
• Perform room and equipment cleaning and 6S in the cleanroom.
• Ensure accurate documentation and labeling for QC samples and batches.
• Maintain inventory accuracy for components and supplies.
• Follow line clearance to ensure cGMP/cGLP compliance.

Skills

Aseptic filling

English proficiency

GMP knowledge

Cleanroom discipline

Documentation skills

Safety compliance

Good communication

Education

High School Diploma

ISO5 cleanroom gowning certification

Job description

FUJIFILM Biosciences in California is seeking an Aseptic Filing Tech for the 2nd shift (1:00pm–9:30pm) in Irvine. You will operate sterile filtration and filling equipment in a cleanroom and follow strict SOPs to ensure product integrity.

Key duties include equipment set-up, routine disinfection, sample labeling, accurate documentation, line clearance, and maintaining 6S in the cleanroom while upholding cGMP/cGLP standards and workplace safety.