Technician-II/Specialist-GXP - Applied Gene & Cell Therapy Center (Operations, Controls, and Support Group) at Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio

Job Description:

Job Description



At Cincinnati Children's, we come to work with one goal: to make children's health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children's.



Cincinnati Children's is:

• Recognized by U.S. News & World Report as a top 10
  best children's hospitals in the nation for more than 15 years


• Second Among All Children's Hospitals for National Institutes of Health (NIH) Funding


• Recognized as one of America's Best Large Employers (2025) ,
  America's Best Employers for New Grads (2024)


• One of the nation's America's Most Innovative Companies as noted by Fortune


• Consistently certified as great place to work
  


• A Leading Disability Employer as noted by the National Organization on Disability
  


• Magnet® designated for the fourth consecutive time by the American Nurses Credentialing Center (ANCC)
  

JOB RESPONSIBILITIES

• 
  Facility and Equipment: - Oversee and perform day-to-day operations including cleanroom facilities maintenance, project management, and fee-for-service support as assigned. Troubleshoot and correct erroneous results or problems with laboratory equipment. Maintain, repair, calibrate, and/or validate equipment as needed. Monitor proper equipment use by all personnel. Maintain inventory of laboratory supplies and equipment; order supplies from vendors and storeroom and ensure proper storage requirements are met. Maintain stocks of chemicals and solutions. Report equipment and/or facility related system failures or alarms to laboratory management or QA team.


• 
  Operations - Perform day-to-day operations including cleanroom facilities maintenance and equipment maintenance plus fee-for-service support as assigned. Operate standard laboratory equipment according to protocol. Promptly respond to and troubleshoot erroneous results or problems with laboratory equipment or facilities. Order supplies from vendors and storeroom and ensure proper storage requirements are met. Maintain stocks of chemicals and solutions. Report facility and equipment failure and alarms to laboratory management or QA team. Perform maintenance and cleaning of the cleanroom manufacturing facility. Routinely perform the Environmental Monitoring sampling and/or testing of the sampled media. Support equipment and facility calibration and validation activities. Request and schedule services with vendors related to lab, cleanroom, and equipment operations. Complete accurate and detailed records. Complete and maintain training required to perform assigned tasks.


• 
  Compliance - Perform work with a high level of integrity and honesty. Practice a high level of integrity in maintaining confidentiality. Maintain required documentation systems. Provide Material Safety Data Sheet (MSDS) training according to regulations. Communicate with external vendors to obtain technical information as needed. Assists in daily operations of the laboratory including answering phone, maintaining lab supplies, organization, and cleanliness. Provide written and oral reports to management on a regular basis. Provide appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.) Perform other duties as assigned.


• 
  Process Improvement - Create, modify, and follow Standard Operating Procedures (SOPs) and Validation Protocols. Cooperate with performance improvement initiatives and other compliance activities. Interact with QA to coordinate manufacturing, processing, and testing activities (i.e. production suite cleaning schedule, release of the production suite, issuance of batch record, completion of equipment validations, etc.). Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance. Perform assigned duties strictly according to SOP. Maintain optimal protocol and assay accuracy by conducting regular quality and reproducibility checks. Maintain required proficiency and competency requirements.


• 
  Manufacturing - Analyze data, perform statistical and graphical analysis of data, and interpret results. Perform qualification and validation activities for equipment/instrumentation, facilities, laboratory methodology and quality assurance procedures that are essential to the GxP operations.. Maintain an active role in the department meetings, presentations, and publications.


• 
  Training & Development - Train laboratory personnel on proper GxP and regulatory compliance techniques. Act as a mentor to more junior staff. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. May provide input and feedback to managers on hiring decisions, professional development and performance management.

Development, technology transfer, scale up, manufacturing/processing/ and or testing; Qualifications and validations. Analyze data and assist others.



Preferred:

• Experience in a regulated environment (i.e. FDA, ISO, CAP, CLIA, FACT)


• cGMP experience


• Cleanroom Operations

JOB QUALIFICATIONS

• 
  Required for Technician II-GxP:
  
  
  


• Bachelor's degree in a related field


• 0 - 2 years of work experience in a related job discipline


• 
  Required for Specialist GxP:
  
  
  


• Bachelor's degree in a related field


• 2 - 5 years of work experience in a related job discipline

Expected Starting Salary Range: 25.05-30.75 (Tech II) 28.58-36.53 (Specialist)



Market Leading Benefits Including*:

• Medical coverage starting day 1 of employment. View employee benefits here.
  
  


• Competitive retirement plans
  
  


• Tuition reimbursement for continuing education
  
  


• Expansive employee discount programs through our many community partners
  
  


• Shift Differential, Weekend Differential, and Weekend Option Pay Programs
  
  


• Referral bonus program for current staff!
  
  


• Support through Employee Resource Groups such as African American Professionals Advisory Council, Asian Cultural and Professional Group, EQUAL - LGBTQA Resource Group, Juntos - Hispanic/Latin Resource Group, Veterans and Military Family Advocacy Network, and Young Professionals (YP) Resource Group
  
  


• Physical and mental health wellness programs
  
  


• Relocation assistance available for qualified positions
  
  

*Benefits may vary based on FTE Status and Position Type



Primary Location

Location S



Schedule

Full time



Shift

Day (United States of America)



Department

EH&CanBio - Translational Labs



Employee Status

Regular



FTE

1



Weekly Hours

40


Comprehensive job description provided upon request.


Cincinnati Children's is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability Apply Now