cGMP Cleaner

TekWissen LLC; Frederick (MD); On-site; USD 30,000 - 44,000; Part time

Job summary

TekWissen Group is assisting a leading biotech client in Frederick, MD, by hiring a cGMP Cleaner (Lab Tech II) for a 12-month temporary assignment onsite. The role supports startup of a new commercial cell-therapy facility, performing 3rd shift cGMP cleaning and stocking sterile/non-sterile garments in ISO-class rooms.

The position requires an AA degree or HS with 1+ years in pharma/biotech, ability to wear PPE, operate in ISO Class cleanrooms, and lift up to 40 pounds.

Qualifications

• AA Degree or HS with 1+ year pharma/biotech/manufacturing experience.
• Able to don cleanroom PPE and wear respirator when required.
• Experience in ISO Class cleanrooms.

Responsibilities

• Perform sanitary cleaning per SOPs and supervisor directions.
• Stock and stage sterile and non-sterile garments for gowning rooms.
• Maintain accurate records and inventory of cleaning supplies.
• Complete training per SOPs and policies.
• Sign off on documentation and assist other departments as needed.
• Uphold safety and quality culture.

Skills

GMP Cleaning

Documentation

Safety adherence

Education

Associate degree or HS with 1+ year experience

Job description

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Position:

cGMP Cleaner

Location:

Frederick, MD

Duration:

12 Months

Job Type:

Temporary Assignment

Work Type:

Onsite

Shift Timing:

Monday to Friday From 7:30am to 4:00pm

Job Description:

• GMP cleaning team.
• 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'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 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

TekWissen Group is an equal opportunity employer supporting workforce diversity.