Job Description

Position Description:

We are seeking a highly motivated individual to join our Manufacturing organization as a cGMP Cleaner and support the startup of a 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.

Responsibilities

• Performs sanitary cleaning activities as defined by established operating procedures and as directed by the 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 an 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 of donning and wearing cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE is essential for the health and safety of employees)

•Ability to wear a respirator during the use of certain cleaning chemicals

•Perform operations within an ISO Class clean room

• 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

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