Job Details
Job Title cGMP Cleaner
Hours: 10:30pm- 7:00am (mandatory 1 weekend day a week)
Training hours: 1st three weeks Monday- Friday 8am-4:30pm
Location: 100% Onsite Frederick, MD
Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta and Tecartus , along with a robust pipeline of various autologous and allogeneic clinical programs.
We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and support the startup of Kite s brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland. The cGMP Cleaner, internally known as a Lab Tech I, will provide 3rd shift cGMP cleaning requirements and sterile and non-sterile garment stocking for our ISO Class rooms and Controlled Non-Classified Lab Areas.
Responsibilities
Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor
Performs sterile and non-sterile stocking, staging and shifting (FIFO) of usable garments for multiple gowning rooms
Maintains accurate and complete records
Attends and completes all training required by Company SOPs, procedures and policies
Maintains accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
Reviews and provides signatory signoff of documentation
Provides accurate and complete assistance to other Departments as needed
Works in a safe and effective manner in accordance with all company, state and federal rules and regulations
Perform any other tasks/duties as assigned by management
Embrace the QUALITY culture
Basic Requirements:
AA Degree
OR
High School Degree with 1+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience
Physical Environment and Physical Requirements:
Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees)
Perform operations within an ISO Class clean rooms
Employee must be able to occasionally lift and/or move up to 40 pounds
Employee must be able to wear a respirator during use of certain cleaning chemicals
Must be able to squat, bend, kneel, and or reach for 80% of a shift
Must be able to stand, walk, and/or move about for 80% of a shift
Preferred Qualifications:
Clean Room sanitization experience or cGMP operational experience a plus