Aeptic Cleaning Technician

Actalent; Colorado; On-site; USD 32,000 - 42,000; Full time

Job summary

6AM City, LLC is seeking a Cleaning Technician for a contract position in Louisville, CO to support a GMP facility manufacturing advanced therapies. You will perform routine cGMP cleaning of clean-room suites and controlled spaces, document activities, and follow SOPs to maintain aseptic conditions.

Responsibilities include environmental monitoring support, basic lab tasks (pH, conductivity), inventory and gowning supplies, and adherence to GDP/GMP guidelines.

Qualifications

• 1+ year cGMP clean-room cleaning experience preferred.
• Experience in GMP/GDP environments and adherence to SOPs.
• Able to follow detailed written instructions and records.

Responsibilities

• Perform routine and specialized cGMP cleaning of clean-room suites and controlled spaces to maintain aseptic environments.
• Prepare and complete cleaning activities, including setup, teardown, and documentation.
• Follow SOPs, GMP, GDP, and controlled documents accurately.
• Aseptically transfer materials and assist with equipment setup as needed.
• Maintain inventory of gowning materials and cleaning supplies; restock as required.
• Support environmental monitoring activities and validation routines.
• Complete documentation timely and accurately; comply with safety guidelines.
• Work nights, weekends, and holidays as needed to support operations.

Skills

cGMP cleaning

Clean-room SOPs

Aseptic technique

Documentation skills

Safety compliance

Team collaboration

Attention to detail

Education

High school diploma or equivalent

Job description

Job Description

Job Description

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 around chemicals and biological materials safely and responsibly.
• Ability to regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Willingness and ability to work nights, weekends, and holidays as needed to support manufacturing operations.
• Strong organization and communication skills, with the ability to work independently after appropriate training.

Job Type & Location

This is a Contract position based out of Lo