Aseptic Cleaning Technician - CGMP
5 days ago
Louisville
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., • 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. 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 About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.