CGMP Cleaning Technician
Job
Actalent
Louisville, CO (In Person)
$53,383 Salary, Full-Time
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Job Description
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 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. Additional Skills & Qualifications Experience in a highly GMP-regulated clean-room environment within pharma, biotech, or biologics manufacturing, especially in a lead or senior role, is highly desirable. Background in GLP-regulated environments, aerospace, oil, or food and beverage manufacturing, particularly in lead roles, is considered a strong plus. Demonstrated experience working on results-oriented teams where collaboration and individual contribution are critical to success. Proficiency with computer applications such as word processing, spreadsheets, and web-based systems for documentation and training. Self-motivated, proactive approach with strong attention to detail and a commitment to quality and compliance. Ability to build effective working relationships across manufacturing, quality, and other technical teams. Interest in career growth into roles such as material handler, laboratory technician, analytical development, manufacturing associate, or research associate. Openness to mentorship and professional development through structured mentor programs that provide exposure to different departments, roles, and career paths. Job Type & Location This is a Contract position based out of Louisville, CO. Pay and Benefits The pay range for this position is $22.96 - $28.37/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Louisville,CO.
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