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Environmental Monitoring Technician

Company: FISI - FUJIFILM Irvine Scientific
Location: Santa Ana
Posted on: January 12, 2021

Job Description:

Overview Irvine Scientific, a member of Fujifilm Holdings Corporation, 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 cell therapy and--regenerative--medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large- scale production of biotherapeutics and vaccines. 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 45 years, Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. Additional information can be found at www.irvinesci.com.We are hiring for two Environmental Monitoring Technicians (one 1st shift, one 2nd shift). The Environmental Monitoring Technician performs tests for monitoring environmental conditions throughout the facility during sterile filling activities and maintains all documentation for tracability. The person in this role will also perform designated testing, monitoring, calibration, and maintenance of lab equipment in conjunction with approved procedures and test methodologies. **External US 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* Test environmental conditions to monitor regulated areas* Maintain and record data clearly and precisely * 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 excursionsExperience/ Education:* High School diploma required; some college courses in Microbiology preferred, degree in Microbiology ideal* 0-1 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* Understanding of good lab safety practices* Basic understanding of 21CFR211 - cGMP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD-93/42 with emphasis on laboratory testing, material specifications, and related areasIrvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic--protected by applicable federal, state, or local law.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.

Keywords: FISI - FUJIFILM Irvine Scientific, Santa Ana , Environmental Monitoring Technician, Professions , Santa Ana, California

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