We are hiring a Environmental Monitoring Tech II. 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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

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.

Required Skills/Education:

• 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.
• Shift 9pm-5:30am

Salary and Benefits:

• For California, the base salary range for this position is $31.11-$35.00 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       

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.

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).