Oversee the day-to-day quality control activities in the lab as they relate to environmental monitoring (EM) at FUJIFILM Cellular Dynamics. Responsible for scheduling and performing 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. 

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

Essential Job Functions

• Take a lead role in daily work in the EM department, including training, guiding and providing task direction to EM personnel.
• EM subject matter expert, knowledgeable in applicable guidance and regulations as they relate to EM (i.e. ISO, PDA, EudraLex).
• Responsible for all tracking, trending and drafting of quarterly EM reports.
• Work with EM management, manufacturing, facilities, and quality control to develop sound EM sampling following current ISO and EU standards.
• Manage investigations for out of specification results as well as related corrective actions of any problems and/or deviations that may affect integrity of data. Work as liaison with manufacturing and facilities in leading EM investigations.
• Work with Quality leadership and EM Specialists to address any laboratory or facility concerns regarding methods, operations, quality or safety.
• Draft, review, and updating of SOPs related to EM testing, systems, and equipment.
• Perform Environmental Monitoring of EU Grade B to D cleanrooms using viable air samplers, contact plates and total air particle counters.
• Ensure the use of proper aseptic technique during execution of EM related tasks.
• Follow good documentation practices in all aspects and phases of the work.
• Mentor and train less experienced staff.
• Other duties as assigned.

Qualifications

• A.S./ A.A.S. in Biology, Microbiology, or Biotechnology with two (2) years of hands-on Environmental Monitoring experience, OR B.S. in Biology, Microbiology, or Biotechnology.
• Four (4) years of direct experience with aseptic sampling in a controlled environment (Grade A/B ISO 5/7), including associated instrumentation (i.e. non-viable and viable samplers).  Experience includes handling various microorganisms including, but not limited to, growth promotion & re-streaking isolates for identification.
• Experience in cGMP or comparable regulated environment (grades B to D) required. 
• Knowledge of EM lab equipment and techniques (e.g. SAS, MAS, Climet, MetOne particle counter, viable airborne monitoring (active and passive), required. Able to troubleshoot and train others in equipment usage.
• Knowledge of MODA Informatics for EM preferred.
• Understanding of proper aseptic technique essential.
• Demonstrated strong work ethic, initiative, the ability to multi-task, and a desire to acquire new technical skills.
• 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 (Word and Excel).
• Demonstrated flexibility in adjusting to changing priorities and schedules.
• Willing and able to work weekend hours when needed.
• 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.
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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 (FCDIHRGroup@fujifilm.com).