Aseptic Cleaning Technician

Job Description

We are seeking a dedicated and capable cGMP clean-room cleaning technician to support Manufacturing Operations in our newly constructed early-stage cell/gene therapy GMP manufacturing facility located in Louisville, CO. Ensuring the production of safe, high-quality products in a highly controlled environment is of paramount importance, and cleaning is an essential part of this process.

Responsibilities

• Coordinate with personnel and the cleaning team to schedule and execute cleaning.
• Follow SOPs to prepare cleaning solutions and perform clean-room area cleaning, including daily routine, monthly, quarterly, and return to service.
• Document cleaning activities in area logbooks.
• Assist in leading a team of cleaning technician contractors with their duties.
• Manage Manufacturing Operations Cleaning technician contractors by assigning work tasks, holding 1:1 meetings to deliver feedback and expectations, and bringing both concerns and ideas for efficient work processes.
• Coordinate with personnel to schedule and lead 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.
• Follow and execute tasks per controlled documents and standard operating procedures.
• Work while wearing clean-room gowning materials.
• Adhere to Standard Operating Procedures, good manufacturing practices, and good documentation practices.
• Perform cGMP cleaning in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9).
• Lead and perform equipment cleaning in accordance with inventory management.
• Review GMP documentation such as logbooks.
• Train and onboard new team members as required.
• Other duties as needed.

Essential Skills

• High school degree or equivalent.
• cGMP clean-room cleaning experience in pharmaceutical, biologics, or medical device fields, or equivalent in work experience or education.
• Proficiency in environmental monitoring, aseptic technique, cGMP regulations, SOP, GLP, EMPQ, FDA, and GDP.

Additional Skills & Qualifications

• Experience working on results-oriented teams where contribution and collaboration are critical.
• Exceptional judgment and initiative in resolving problems and making recommendations.
• Proficiency in computer applications such as word processing, spreadsheets, and web-based applications.
• Self-motivated with strong organizational and communication skills, capable of working independently.