Job Title: cGMP Cleaner (Lab Tech I)

Job Location: Frederick, MD 21704

100% onsite

Job Duration: 06 Months Contract (possible extension)

Job Description

We are seeking a highly motivated individual to join our Manufacturing organization as a cGMP Cleaner and support the startup of client's 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 Classrooms 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)
• 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