cGMP Cleaner

Planet Pharma Group; Frederick (MD); On-site; USD 32,000 - 39,000; Full time

Job summary

Planet Pharma in Frederick, MD is seeking a Lab Tech II to join the cGMP cleaning team on a 3rd shift. The role includes sterile and non-sterile garment stocking, documentation, and cleanroom support in a state-of-the-art facility.

Responsibilities include sanitation per SOPs, inventory management, and signatory documentation. Requires an AA degree or HS with 1+ year pharma/manufacturing experience; PPE and ISO Class cleanroom work are required.

Qualifications

• AA Degree or HS diploma with 1+ years in pharmaceutical/biotech/manufacturing.
• Able to wear PPE and operate in ISO Class cleanrooms.

Responsibilities

• Performs sanitary cleaning in established procedures and per supervisor direction.
• Performs sterile and non-sterile stocking and FIFO of garments for gowning rooms.
• Maintains accurate records and completes training per SOPs.
• Maintains inventory of cleaning supplies to prevent depletion.
• Completes signatory documentation and provides cross-departmental assistance.
• Adheres to safety rules and company/state/federal regulations.
• Performs other duties as assigned; supports QUALITY culture.

Skills

Sanitation

Documentation

Record keeping

Gowning procedures

Education

AA Degree

High School Diploma

Job description

Description

GMP cleaning team Job Title cGMP Cleaner 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 the companies 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 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 break down (by %): 75% cleaning 15% documentation 10% other duties as assigned

Pay ranges between 23-28/hr based on experience