cGMP Cleaner

TekWissen ®; Frederick (MD); On-site; USD 34,000 - 39,000; Full time

Job summary

TekWissen Group is sourcing a cGMP Cleaner to support a state‑of‑the‑art cell therapy facility in Frederick, MD. The role focuses on 3rd shift cleaning, sterile and non‑sterile garment stocking for ISO Class rooms, and maintaining precise records.

Candidates should be able to wear cleanroom PPE, complete required training, and work within ISO cleanroom standards. Prior pharma/biotech/manufacturing experience is preferred, with emphasis on safety and SOP adherence.

Qualifications

• AA Degree or high school diploma with 1+ years of pharmaceutical/biotech/manufacturing experience.
• Ability to wear cleanroom PPE and respirator as required.
• Must work in ISO Class clean rooms.

Responsibilities

• Performs sanitary cleaning activities as defined by procedures and supervision.
• Stocking, staging and shifting (FIFO) of garments for gowning rooms.
• Maintains accurate records and completes training per SOPs.
• Maintains inventory of cleaning supplies and signs off documentation.
• Assists other departments and adheres to safety rules and regulations.
• Performs other tasks as assigned and supports QUALITY culture.

Skills

Sanitation experience

Recordkeeping

Safety compliance

Teamwork

Education

AA Degree or HS Diploma

Tools

Clean room PPE experience

Job description

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

Pay Rate: $25.00 - $28.00/Hr

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.

Job Description:

GMP cleaning team 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’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.