POSITION SUMMARY

We are seeking a dedicated and capable cGMP clean-room cleaning technician lead to support Manufacturing Operations in our newly constructed early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO. Ensuring that we produce safe, high-quality products in a highly controlled environment is of paramount importance, and cleaning is an essential part. Primary job responsibilities include but are not limited to 1) coordinating with Umoja personnel and the cleaning team to schedule and execute cleaning, 2) following SOPs to prepare cleaning solutions and perform clean-room areas cleaning, (e.g., daily routine, monthly, quarterly, return to service), 3) document cleaning on area logbooks and 4) Assist in leading a team of cleaning technician contractors with their duties. Additional responsibilities may include equipment cleaning, documentation of equipment cleaning in an asset management system, consumable material inventory management and movement in coordination with Supply chain, logbook review, etc. The role requires attention to detail, the ability to both read and directly follow Standard Operating Procedures as well as comply with Safety procedures and work practices.

CORE ACCOUNTABILITIES
Specific responsibilities include:

• Manage Manufacturing Operations Cleaning technician contractors, to include assigning work tasks in coordination with Umoja leadership, holding 1:1 meetings with contractors to deliver feedback and expectations as needed, and bringing both concerns and ideas for efficient and effective work processes.
• Coordinate with Umoja personnel to schedule and lead execution of cleaning activities to support GMP operations, required cleaning schedule, and facility response cleanings.
• Prepare, execute, and clean-up after required cleaning activities within the Controlled spaces of the CLIMB.
• Directly follow and execute the role per controlled documents and standard operating procedures on behalf of Manufacturing Operations
• Ability to work wearing clean-room gowning materials
• Adheres to Standard Operating Procedures, good manufacturing practices, and good documentation practices
• Performs cGMP cleaning in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9)
• Leads and performs equipment cleaning in accordance with relevant SOPs.
• Maintains material inventory and performs stocking activities for gowning, cleaning, and consumable materials to ensure sufficient inventory is available to support manufacturing operations
• Review of GMP documentation (e.g., logbooks)
• Training and onboarding any new team members required to meet goals
• Other duties as needed

Required Qualifications:

• High school degree or equivalent
• At least 4-6 years of cGMP clean-room cleaning experience in the pharmaceutical, biologics and/or medical device field is desired or equivalent in work experience or education
• At least 1 year of team lead experience with demonstrated ability to communicate effectively, motivate personnel, and deliver on schedule

Preferred Qualifications:

• Demonstrated experience working on results-oriented teams where contribution and collaboration were critical to project success
• Exceptional judgment and initiative in resolving problems and making recommendations.
• Proficient in computer applications such as word processing, spreadsheets, and web-based applications
• Self-motivated with strong organization and communication skills and can work independently

Physical Requirements:

• Ability to gown aseptically and work in a Clean Room environment
• Ability to work while gowned for extended periods of time
• Ability to work while reaching and working overhead performing repetitive tasks
• Extensive use and handling of chemicals and biological materials
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Ability to work nights and weekends as needed
• Ability to work holidays and on-call as needed

Salary Range: $74,800 - $92,400. This is a non-exempt role.