Manufacturing Lab Technician

Fladger Associates; Frederick (MD); In loco; USD 30.000 - 41.000; Tempo pieno

Descrizione del lavoro

Fladger Associates seeks a dedicated Lab Tech II to join our Manufacturing team in Frederick, MD. The role focuses on 3rd shift cGMP cleaning for ISO Class rooms and controlled areas, including garment stocking and gowning support.

Training is provided; candidates must pass PPE and safety requirements and contribute to a quality-driven facility startup. This is a full‑time, on‑site position supporting a state‑of‑the‑art cell therapy operation.

Competenze

• Experience in cleanroom environments and sterile/non-sterile stocking procedures.
• Familiarity with cGMP operational practices and ISO Class rooms.
• Ability to maintain accurate records and complete documentation per SOPs.
• Comfort with wearing PPE and performing hand-offs and sign-offs.

Mansioni

• Perform sanitary cleaning to cGMP standards in ISO Class rooms and clean labs.
• Stock, stage, and manage garments (FIFO) for gowning rooms, both sterile and non-sterile.
• Maintain accurate inventory of cleaning supplies and ensure supplies are not depleted.
• Attend required training and complete SOP-based tasks.
• Review and sign off on documentation; assist other departments as needed.

Conoscenze

Cleanroom operations

Gowning & PPE

Documentation

Safety compliance

Formazione

AA Degree

High School Diploma with 1+ year experience

Descrizione del lavoro

• Hours: 5x8 hours days 10:30pm- 7:00am (mandatory 1 weekend day a week)
• Training hours: 1st three weeks Monday- Friday 7:30am-4:00pm
• A cell therapy company that is focused on providing patients with highly effective, life-saving therapies.
• We have two commercial products, 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 company’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.
• 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

Experience:

• 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