CGMP Cleaning Technician

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.
• Cook up and support the restocking of gowning areas and clean-room consumables to ensure uninterrupted operations.
• 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.
• 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 effectively as part of a results-oriented team, collaborating with colleagues in manufacturing and related functions to achieve project and production goals.
• 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.
• Experience with basic measurements and tasks such as pH and conductivity testing, weighing, dispensing, and solution preparation.
• 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.
• Ability 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 Louisville, CO.

Pay And Benefits

The pay range for this position is $22.96 - $28.37/hr.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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.