Aseptic Filling Technician - 2nd Shift

FUJIFILM Biosciences; Santa Ana (CA); On-site; USD 50,000 - 64,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences in Santa Ana, CA is seeking an Aseptic Filing Tech to support sterile filtration, filling, and cleanroom operations on the 2nd shift (1:00pm–9:30pm). The role requires hands-on experience with aseptic filling systems, cleanroom gowning, and GMP/compliant documentation.

The successful candidate will maintain equipment and batch setup, perform QC sample labeling, and participate in continuous SOP improvements while ensuring safety and accuracy in a fast-paced biopharma

Qualifications

• High School Diploma or equivalent.
• 2+ years preferred as aseptic filling technician.
• Experience with manual and automated aseptic fill systems.
• ISO 5 cleanroom gowning certification.
• Knowledge of GMPs and documentation.
• English reading/writing and communication skills.

Responsibilities

• Prepare and set-up aseptic filling/filtration equipment in a cleanroom environment.
• Follow aseptic-filling procedures with manual or automated filling systems.
• Maintain cleanroom behavior and gowning per SOPs.
• Disinfect controlled areas in compliance with SOPs.
• Perform room/station set up and batch set up activities.
• Ensure complete and accurate documentation of work performed.
• Navigate electronic documentation system.
• Maintain inventory accuracy for components and supplies used for batch.
• Follow line clearance to ensure CGMP and cGLP compliance.
• Adhere to safety procedures and wear PPE.
• Clean room and equipment per procedures; maintain 6S organization.
• Ensure essential supplies are stocked and request replenishment as needed.
• Complete filter integrity testing timely and accurately.
• Perform container/component staging and QC sample labeling as required.
• Assist in SOP revisions and other duties as assigned by Lead/Supervisor.

Skills

Aseptic filling

Cleanroom procedures

GMP knowledge

English communication

Documentation/recordkeeping

Education

High School Diploma

Certified aseptic filling technician

ISO 5 cleanroom gowning certification

Tools

Automated filling systems

Job description

We are hiring an Aseptic Filing Tech. The Aseptic Filing Tech will be responsible for sterile filtration and filling, sterilizing filters, containers and closures

This is for 2nd shift: 1:00pm- 9:30pm

Company Overview

At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world's biggest health challenges. Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you're ready to make an impact, your future belongs with us at FUJIFILM Biosciences. Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

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.
• Perform 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.
• 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 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).
• Other duties as assigned by Lead or Supervisor.

Required Skills/Education

• 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

Salary And Benefits

• For California, the base salary range for this position is $24.17 - $31.42 per hour. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).