Environmental Monitoring Specialist (#315)

  • Full-time
  • Department: Quality

Company Description

FUJIFILM Cellular Dynamics is a leading developer and supplier of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. We partner with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. Our technology can be used to create induced pluripotent stem cells (iPSCs) from anyone and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system result in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development

Job Description

FUJIFILM Cellular Dynamics, Inc in Madison, WI is recruiting for an Environmental Monitoring Specialist to support the opening of our new cGMP research and development facility.  This newly created role provides an outstanding opportunity for a talented self-motivated individual who can contribute to our ongoing efforts to generate differentiated cell types from human induced pluripotent stem cells,.   We are most interested in connecting with qualified individuals who aspire to support the development of therapeutics and/or life science products and tools to support research endeavors.  In return we provide development and support to enhance your career using cutting edge iPSC technology.

The impact teammate will implement and maintain FUJIFILM Cellular Dynamic’s (FCDI) environmental monitoring (EM) program.  The role supports the creation, maintenance, and continuous improvement of the EM program at FCDI.  Additionally, you'll perform quality control activities as they relate to EM tasks, plus perform routine and non-routine environmental monitoring to aid in detecting, quantifying and identifying environmental microbial contaminants.

Essential Job Functions

  1. Support the implementation, maintenance and continuous improvement of the environmental monitoring program.
  2. Perform environmental monitoring of ISO class 5 thru 8 cleanrooms using standard methods and equipment such as air samplers and contact plates, to include but not limited to the use of environmental monitoring lab equipment and techniques (e.g. SAS, MAS, Climet particle counter, viable airborne monitoring (active and passive), total airborne particulate sampling, viable surface monitoring, and personnel monitoring).
  3. Assist in daily organization of microbiology laboratory including cleaning, maintenance and ordering of supplies.
  4. Complete documentation consistent with good documentation practices in all aspects and phases of the work, providing time reports and updates to teammates. 
  5. Apply proper aseptic technique during execution of environmental monitoring related tasks.
  6. Perform 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.
  7. Oversee and manage microbiological environmental monitoring database and prepare - reports as requested.
  8. Perform maintenance of environmental monitoring database evaluating trend data.
  9. Assist in calibrating and maintaining lab equipment.
  10. Receive, quarantine, and test supplies and raw materials for quality control testing, including testing of commercially prepared microbiological culture media, and perform quality control review of data records.
  11. Write, review, and update SOPs related to quality control testing, systems, and equipment.
  12. Other job functions as assigned.

Qualifications

  • Bachelor’s degree in a life science discipline such as but not limited to bacteriology or micro-biology , or Associate’s degree in comparable field plus two years of relevant experience. 
  • 2 years of relevant experience within a cGMP or comparable regulated environment with demonstrated achievements and progressive responsibilities
  • Proficient with aseptic technique
  • Functional proficiency with data manipulation, analysis, and communication of results
  • Demonstrated capability with MS Office product suite
  • Demonstrated ability to work independently, handle multiple and changing priorities, acquire new technical skills and effectively communicate across diverse employee audiences
  • Ability to work weekends as required
  • Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) 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

Additional Information

 

FUJIFILM Cellular Dynamics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability. All qualified applicants will not be discriminated against on the basis of a disability.