Job Title: Aseptic Cleaning Technician
Job Description
The Aseptic Cleaning Technician supports manufacturing operations in a newly constructed early-stage cell and gene therapy GMP manufacturing facility in Louisville, CO. This fully onsite role focuses on maintaining a highly controlled clean-room environment through cGMP-compliant cleaning, aseptic material transfer, equipment setup, and adherence to Standard Operating Procedures. The position plays a critical role in ensuring that products are manufactured in a clean, safe, and compliant environment that supports cutting-edge immunotherapy development.
Responsibilities
- Perform routine and specialized cGMP cleaning of controlled clean-room suites (ISO5, ISO7, ISO8, ISO9) to maintain a highly controlled and compliant environment.
- Prepare, execute, and complete all required cleaning activities within controlled spaces, including thorough pre- and post-cleaning setup and cleanup.
- Set up equipment and materials for manufacturing operations in accordance with controlled documents and Standard Operating Procedures.
- Aseptically transfer materials into the manufacturing space while maintaining clean-room integrity and aseptic technique.
- Follow Standard Operating Procedures (SOP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) consistently and accurately.
- Participate in equipment, process, and system validation activities, including Environmental Monitoring Performance Qualification (EMPQ) and return-to-service activities.
- Maintain inventory and perform stocking activities for gowning materials, cleaning supplies, and consumables to ensure continuous support for manufacturing operations.
- Support the development of operating schedules and help ensure adherence to schedules for manufacturing task execution.
- Perform basic laboratory support tasks such as pH measurement, conductivity testing, weighing and dispensing solutions, and solution preparation as needed.
- Assist with downstream manufacturing activities under the direction of manufacturing operations.
- Work while fully gowned in clean-room attire for extended periods, including performing repetitive tasks and working overhead when required.
- Handle chemicals and biological materials safely and in compliance with applicable regulations and internal procedures.
- Lift and move materials and equipment regularly in the 1020 lb range and periodically up to 50 lbs to support manufacturing and cleaning operations.
- Work nights, weekends, and holidays as needed to support manufacturing schedules and facility needs.
- Perform other related duties as assigned to support manufacturing operations and facility readiness.
Essential Skills
- High school diploma or equivalent.
- At least 1 year of cGMP clean-room cleaning experience in a pharmaceutical, biologics, or medical device environment, or equivalent work experience in a GMP-regulated setting.
- Demonstrated experience working in a highly regulated clean-room environment with strict adherence to GMP requirements.
- Strong understanding of cGMP regulations and clean-room operations.
- Ability to follow Standard Operating Procedures precisely and complete tasks consistently and correctly.
- Proficiency with computer applications such as word processing, spreadsheets, and web-based systems.
- Proficiency in aseptic technique and working in controlled environments.
- Familiarity with GLP (Good Laboratory Practice) environments.
- Ability to gown aseptically and work in a clean-room environment for extended periods.
- Ability to perform repetitive tasks, including reaching and working overhead.
- Comfort working around laboratories, manufacturing areas, and equipment, with the ability to regularly lift 1020 lbs and periodically up to 50 lbs.
- Ability and willingness to work nights, weekends, and holidays as needed.
Additional Skills & Qualifications
- Experience with environmental monitoring and Environmental Monitoring Performance Qualification (EMPQ).
- Experience in FDA-regulated environments such as pharma, biotech, or biologics clean rooms, especially in leadership roles.
- Experience in GLP-regulated environments, aerospace, oil, or food and beverage manufacturing, particularly with leadership experience.
- Knowledge of clean-room classifications and practices (ISO5, ISO7, ISO8, ISO9).
- Experience with pH measurement, conductivity testing, and solution preparation.
- Exposure to downstream manufacturing operations in a GMP environment.
- Ability to work effectively in unified, joyful, and collaborative teams with a strong focus on patients.
- Interest in career growth into roles such as material handler, laboratory positions, analytical development, manufacturing associate, or research associate.
- Openness to mentorship and participation in structured mentor programs for career development and cross-functional exposure.
Work Environment
This position is fully onsite in a highly regulated clean-room environment at a cell and gene therapy GMP manufacturing facility in Louisville, CO, operating five days per week. The role requires full aseptic gowning for extended periods, including the use of hair nets, safety goggles, gloves, jumpsuits, booties, and other personal protective equipment. Work is performed in controlled clean-room spaces (ISO5, ISO7, ISO8, ISO9) with frequent interaction with laboratories, manufacturing areas, and equipment, as well as regular handling of chemicals and biological materials. The environment may require working nights, weekends, and holidays to support manufacturing schedules. The culture emphasizes inclusivity, collaboration, and a strong focus on patients, with unified and joyful teamwork. Facilities include inclusive changing areas and all-gender bathrooms with full privacy doors extending from floor to ceiling. Contractors are welcomed and included in most company events. Employees and consultants benefit from a robust mentor program that supports career development, networking, and exposure to different departments, roles, and jobs, with clear career pathing into roles such as material handler, lab, analytical development, manufacturing associate, and research associate.
Job Type & Location
This is a Contract position based out of Louisville, CO.
Pay and Benefits
The pay range for this position is $24.50 - $28.00/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
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)
Job Type & Location
This is a Contract position based out of Louisville, CO.
Application Deadline
This position is anticipated to close on Nov 18, 2026.
Workplace Type
This is a fully onsite position in Louisville,CO.
About Actalent
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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 actalentaccommodation@actalentservices.com for other accommodation options.
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