Aeptic Cleaning Technician

Cleaning Technician

The Cleaning Technician supports manufacturing operations in a newly constructed early-stage cell and gene therapy GMP facility by performing critical cGMP clean-room cleaning and related activities in a highly controlled environment. This fully onsite role, based in Louisville, CO, ensures that manufacturing suites, equipment, and materials remain in a state of control to support the production of advanced therapies. The technician follows detailed Standard Operating Procedures (SOPs), works in classified clean-room areas, and contributes directly to the safe and compliant manufacture of life-changing treatments.

Responsibilities

• Perform routine and specialized cGMP cleaning of clean-room suites and controlled spaces (ISO5, ISO7, ISO8, ISO9) to maintain a highly controlled aseptic environment.
• Prepare, execute, and complete all required cleaning activities, including pre-clean setup and post-clean teardown and documentation.
• Follow and execute all tasks in strict accordance with controlled documents, Standard Operating Procedures (SOPs), good manufacturing practices (GMP), and good documentation practices (GDP).
• Aseptically transfer materials and equipment into the manufacturing space while maintaining clean-room integrity and contamination control.
• Execute equipment setup and basic support activities for manufacturing operations as directed by established procedures.
• Maintain inventory and perform stocking activities for gowning materials, cleaning supplies, and consumable items to ensure adequate levels are available to support manufacturing schedules.
• Coordinate and support the restocking of gowning areas and clean-room consumables to ensure uninterrupted operations.
• Participate in equipment, process, and system validation activities, including Environmental Monitoring Performance Qualification (EMPQ) and return-to-service activities.
• Adhere to environmental monitoring practices and support environmental monitoring activities as required.
• Ensure development and adherence to operating schedules for manufacturing task execution, helping to keep activities on time and aligned with production needs.
• Perform basic laboratory-related tasks as needed, such as pH and conductivity measurements, weighing and dispensing of solutions, and solution preparation.
• Provide assistance to downstream manufacturing activities when required, following appropriate training and procedures.
• Work effectively as part of a results-oriented team, collaborating with colleagues in manufacturing and related functions to achieve project and production goals.
• Complete all documentation accurately, legibly, and in a timely manner to meet regulatory and quality requirements.
• Follow all safety procedures and handle chemicals and biological materials in compliance with safety and regulatory guidelines.
• Work nights, weekends, and holidays as needed to support manufacturing schedules and facility operations.
• Perform other related duties as assigned to support manufacturing, facility readiness, and continuous improvement initiatives.

Essential Skills

• High school diploma or equivalent.
• At least 1 year of cGMP clean-room cleaning experience in the pharmaceutical, biologics, or medical device field, or equivalent combination of work experience and education.
• Hands-on experience working in a GMP-regulated clean-room environment, including adherence to cGMP regulations and clean-room protocols.
• Proficiency with aseptic technique and the ability to gown aseptically and work in a clean-room environment for extended periods.
• Familiarity with Standard Operating Procedures (SOPs) and demonstrated ability to follow detailed written instructions consistently.
• Knowledge of good manufacturing practices (GMP) and good documentation practices (GDP).
• Experience with environmental monitoring concepts and Environmental Monitoring Performance Qualification (EMPQ) activities or support.
• Ability to perform basic measurements and tasks such as pH and conductivity testing, weighing, dispensing, and solution preparation.
• Ability to work while reaching and performing repetitive tasks, including overhead work, while fully gowned.
• Capability to handle and work…