cGMP Cleaner

Job Description

Job Summary:

• cGMP Cleaner client 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 client brand new, state-of-the-art, commercial Cell Therapy facility in Frederick, Maryland.
• The cGMP Cleaner, internally known as a Lab Tech II, 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.

Duties and Responsibilities:

• Perform 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.

Education and Experience:

• AA Degree OR High School Degree with 1+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience Physical.

Work Environment and Physical Requirements:

• Physically capable to don and wearing 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).
• Ability to wear a respirator during use of certain cleaning chemicals.
• Perform operations within an ISO Class clean rooms.
• Employee must be able to occasionally lift and/or move up to 40 pounds.
• 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 Task breakdown (by %): 75% cleaning 15% documentation 10% other duties as assigned.