Sr. Environmental Monitoring Specialist

Madison, OH - USA

Monthly Salary: Not Disclosed

Posted on: 14 days ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

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.

Company Overview

At FUJIFILM Cellular Dynamics were 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 were looking for bold innovators to join us.

At FUJIFILM Cellular Dynamics youll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs. If youre 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 70000 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: Description

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.

EEO Information

Fujifilm is committedto 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.

ADA Information

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 ().

Required Experience:

Senior IC

Position OverviewOversee 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 poss...