Sterile Cleaning Technician

Position Summary

The Sterile Cleanroom Cleaning Technician plays a critical role in maintaining environmental control, contamination prevention, and regulatory compliance of ISO-classified cleanroom suites within a 503A compounding pharmacy environment. This individual is responsible for executing daily and monthly cleaning and disinfection protocols across hazardous and non-hazardous sterile compounding suites, weighing/mixing rooms, gowning areas, and corridors. The role ensures strict adherence to Standard Operating Procedures (SOPs), United States Pharmacopeia guidelines (USP 797, USP 800), and state regulations to maintain audit readiness and batch safety.

Key Responsibilities & Essential Functions

Daily & Monthly Cleanroom Sanitation Execution

• Execute daily cleaning and disinfection procedures for Primary Engineering Controls (BSCs, LAFWs, Lyophilizers), ISO 5 zones, pass-throughs, easy surfaces (e.g., carts, benches, chairs, pump stands, crimping stations, viable/non-viable stations), and floors prior to compounding activities.
• Perform comprehensive monthly cleaning of all ISO-8 or better controlled areas, including ceilings, walls, pass-throughs, equipment, and floors using designated sporicidal solutions, sterile Isopropyl Alcohol (IPA), and automated decontamination systems (TOMI Steamiest Surface Select).
• Adhere strictly to clean-to-dirty workflows, top-to-bottom surface wiping (ceilings, walls, easy surfaces, floors), and prescribed overlapping stroke patterns. Maintain required contact/dwell times (e.g., 10-minute sporicidal dwell times) for chemical agents.
• Fully gown and garb in accordance with facility sterile gowning SOPs. Don and remove additional hazardous PPE/gowns and boot covers when servicing Hazardous Drug (HD) suites and weighing/mixing areas to prevent cross-contamination.

Material, Equipment & Solution Management

• Accurately prepare, label, and use facility-approved cleaning agents (e.g., Peridox RTU®, HYPO-CHLOR®, Sterile 70% IPA, Tomi Solution) according to manufacturer and SOP specifications.
• Prepare TexQ mops and mop head covers using sterile dry wipes. Ensure stainless steel mop heads are properly handled for daily steam sterilization/autoclaving. Manage area-captive mops and storage carts to ensure strict separation between hazardous, non-hazardous, and corridor zones.

Waste Removal & Pass-Through Transfer

• Perform structured trash removal across cleanroom suites, hazardous areas, pre-/post-gowning rooms, and weighing/mixing suites. Double-bag hazardous waste.

Documentation & Compliance Support

• Accurately complete and sign all Daily Cleanroom Cleaning Logs (Hazard, Non-Hazard, Corridor, Weighing/Mixing) and Monthly Cleaning Logs (or corresponding pharmacy software entries) immediately after cleaning cycles.
• Assist Quality Assurance in keeping cleaning logs and assessment forms fully up-to-date and audit ready. Perform required cleaning procedures following new equipment introductions, facility maintenance, or environmental monitoring re-certifications.
• Maintain flexibility to adapt to changing operational priorities and complete additional cleaning or quality-related tasks as requested by management.

Education & Experience

• High School Diploma or equivalent required.
• Pharmacy Technician License required
• Previous cleaning, sanitation, or quality control experience in a cGMP, compounding pharmacy (503A/503B), pharmaceutical manufacturing, or hospital cleanroom environment highly preferred.

Knowledge & Competencies

• High attention to detail, precision in following sequential multi-step standard operating procedures (SOPs), and strict adherence to required chemical dwell times.
• Strong understanding of chemical safety, hazardous drug (HD) handling, and proper PPE garbing/de-gowning techniques.
• Ability to lift, bend, push cleaning carts, stand for extended periods, and perform physical wiping/mopping tasks in full cleanroom garbing.
• Familiarity with cleanroom procedures, gowning protocols, or controlled environment safety preferred.

Physical Requirements

• Ability to stand and walk for extended periods during the shift.
• Capability to lift and move supplies weighing up to 20-30 lbs.
• Comfortable working in controlled cleanroom environments while wearing full personal protective equipment (PPE), including gown, mask, gloves, hair and beard net.