Job Description

We are hiring a Environmental Monitoring Tech I. This individual will perform tests for monitoring environmental conditions throughout the facility during sterile filling activities and maintain all documentation for traceability. They will perform/support monitoring of the water systems for GMP and maintain all documentation generated from the various monitoring programs for traceability.

This position will be working 2nd shift 1pm-9:30pm

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

Responsibilities:

• Provide documentation support of testing and monitoring activities in the QC lab.
• Document environmental monitoring of the production rooms. Monitor and report activities related to the on-line monitoring program. Perform testing as designated and upon satisfactory training qualification.
• Testing on environmental conditions to monitor regulated areas.
• Maintain and record data clearly and precisely
• In-process testing of liquid media
• Receive/Process QC Samples of Finished Liquid/Powder Goods
• Provide support to manufacturing for all aseptic validation inspections
• Maintain and record the retention of all Finished Goods received in QC
• Initiate Environmental Monitoring OOS notification and Investigation. Provide feedback on observations during the EM

Required Skills/Education:

• High School diploma. Some college courses in Microbiology preferred. Degree in Microbiology ideal.
• 0-2 year of experience doing environmental monitoring in a cleanroom environment or working in a cleanroom environment.
• Knowledge of cGMP and GDP preferred. Cleanroom experience preferred.
• Good lab safety
• Basic understanding of 21CFR211 – cGMP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD-93/42 with emphasis on laboratory testing, material specifications, and related areas.
• Ability to speak and read English.
• Good oral and written communication skills.

Salary and Benefits:

• For California, the base salary range for this position is $25.68 - $29.00 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

*#LI-onsite

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 (flbi@fujifilm.com).