Environmental Monitoring Specialist I

Fujifilm•Madison, WI

6d•Onsite

About The Position

Position Overview Perform quality control activities as they relate to environmental monitoring (EM) at FUJIFILM Cellular Dynamics. Responsible for helping perform routine and non-routine environmental monitoring to aid in detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of manufacturing and testing processes. Company Overview At FUJIFILM Cellular Dynamics, we’re unlocking the power of human cells to change lives. Using revolutionary induced pluripotent stem cell (iPSC) technology, we drive advancements in drug discovery, disease modeling, cell therapy, research tools, and cell therapy manufacturing. Our mission is deeply meaningful, and we’re looking for bold innovators to join us. At FUJIFILM Cellular Dynamics, you’ll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs. If you’re ready to do work that makes a real impact and propels healthcare forward, this is your chance to be part of something extraordinary for science, patients, and yourself. Our headquarters is in Madison, Wisconsin, a dynamic city celebrated for its lakes, parks, cultural richness, biotech leadership, and access to world-class academia. 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 Job Description Essential Job Functions Assists with Environmental Monitoring of EU Grade B to D cleanrooms using Viable Air samplers, Contact plates and Total Air particle counters. Assists in everyday organization of Microbiology laboratory including cleaning, maintenance and ordering of supplies. Must follow good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects. Ensure the use of proper aseptic technique during execution of EM related tasks. Aid in investigations for out of specification results as well as participate in corrective action of any problems and/or deviations that may affect integrity of data. Assist in updating microbiological EM database and assist in preparation of reports as requested. Assist in maintenance of EM database as well as EM trending. Assist in calibrating and maintaining lab equipment. Receive, quarantine, and test supplies and raw materials for QC testing, including testing of commercially prepared microbiological culture media. Aid in writing, review, and updating of SOPs related to EM testing, systems, and equipment. Must demonstrate flexibility in adjusting to changing priorities and schedules. Other duties as assigned.

Requirements

A.A.S in Biology, Microbiology, or Biotechnology.
Applicants should possess a strong work ethic, initiative, the ability to multi-task, and a desire to acquire new technical skills.
Applicants should have strong written and oral communication skills as well as the ability to work well independently and as part of a team.
Working knowledge of MS Office (Work and Excel)
Some weekend work is required.
Able to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (Eu Grade B to D) gowning material and appropriate shoes required in most areas associated with this position.
Able to work in cleanroom environment for extended periods of time.
Able to work with hazardous materials (i.e. chemicals, electrical equipment and human tissue) without endangering oneself or others.
Able to wear standard laboratory PPE.

Nice To Haves

Experience in cGMP or comparable regulated environment a plus.
Knowledge of EM lab equipment and techniques (e.g. SAS, MAS, Climet, MetOne particle counter, viable airborne monitoring (active and passive), not required but helpful.
Understanding of proper aseptic technique.

Responsibilities

Assists with Environmental Monitoring of EU Grade B to D cleanrooms using Viable Air samplers, Contact plates and Total Air particle counters.
Assists in everyday organization of Microbiology laboratory including cleaning, maintenance and ordering of supplies.
Must follow good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects.
Ensure the use of proper aseptic technique during execution of EM related tasks.
Aid in investigations for out of specification results as well as participate in corrective action of any problems and/or deviations that may affect integrity of data.
Assist in updating microbiological EM database and assist in preparation of reports as requested.
Assist in maintenance of EM database as well as EM trending.
Assist in calibrating and maintaining lab equipment.
Receive, quarantine, and test supplies and raw materials for QC testing, including testing of commercially prepared microbiological culture media.
Aid in writing, review, and updating of SOPs related to EM testing, systems, and equipment.
Must demonstrate flexibility in adjusting to changing priorities and schedules.
Other duties as assigned.