Environment Monitoring Tech II

Fujifilm•Santa Ana, CA

2d•$31 - $35•Onsite

About The Position

The Environmental Monitoring Tech II will perform tests for monitoring environmental conditions throughout the facility during sterile filling activities and maintain all documentation for traceability. This is for 3rd shift- 9:00pm-5:30am. 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.”

Requirements

High School diploma.
Some college courses in Microbiology preferred.
Degree in Microbiology ideal.
2-3 years 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.

Nice To Haves

Some college courses in Microbiology preferred.
Degree in Microbiology ideal.
Knowledge of cGMP and GDP preferred.
Cleanroom experience preferred.

Responsibilities

Provide documentation support of testing and monitoring activities in the QC lab. Includes but not limited to Clean Room and Water System data. Maintain and record data clearly and precisely
Document environmental monitoring of the production rooms. Report activities related to the on-line monitoring program. Perform testing as designated
Perform Sterility testing on the Finished Liquid products, as necessary
Perform identification and related testing in conjunction with microbial contamination.
Maintain an organism library while documenting and archiving new organisms found in clean rooms.
Provide training to new hires or Mfg. personnel assigned to QC EM tasks for support
Support equipment validations for equipment related to EM
In-process testing of liquid media as necessary
Assist in extensive EM OOS investigations
Receive/Process QC Samples of Finished Liquid/Powder Goods
Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
Support production and manufacturing activities as needed as a quality representative
Other duties as necessary.