Environmental Monitoring Technician

FUJIFILM Irvine Scientific, Inc. is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company's consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation

We are hiring an Environmental Monitoring Technician. The Environmental Monitoring Technician will perform tests for monitoring environmental conditions throughout the facility during sterile filling activities and maintain all documentation for traceability.

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 online 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
• Initiate Environmental Monitoring OOS notification and Investigation.
• 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 information regarding environmental monitoring excursions
• Perform weekly monitoring of the FISI water systems (RODI & WFI)
• In-process testing of liquid media
• Enteric testing on varieties of containers for Production use.
• Provide support to manufacturing for all aseptic validation inspections
• Receive QC samples of Finished Powder/Liquid goods
• Maintain and record the retention of all Finished liquid and powder goods

Required Skills/Education

• High School diploma. Some college courses in Microbiology are preferred. A degree in Microbiology is ideal.
• 1-3 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.

PHYSICAL DEMANDS described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is frequently required to read, compile, compute, and record numerical and statistical data.
• Duties require the employee to gown up for entering the cleanroom. Use of hand dexterity to manipulate fluids and powders to perform applicable tests in clean room environments, laminar flow hoods, and laboratory benches.
• The employee is frequently required to stand. The employee is occasionally required to walk, sit, use hands to handle, feel or reach with hands and arms; climb or balance; and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and depth perception.

WORK ENVIRONMENT The work environment characteristics described here is representative of those an employee encounter while performing the essential functions of this job.

• The noise level in the work environment is that of a busy laboratory office with telephones, computers, and printers operating and with frequent people interruptions.
• Required to perform duties in a laboratory environment with required dress and hygiene.
• Required to work under temperatures that will range between 16-25C

For California, the base salary range for this position is $23.00 to $37.00 hourly. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).

EEO/COVID/AGENCY NOTES

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms'/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms'/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.