Clean Room Technician

1-Year Full-Time Contract

JOB SUMMARY

Under the direct supervision of a licensed Pharmacist or designate, the Cleanroom Technician works in the Cleanroom environment to prepare medication compounding. While maintaining model standard of Sterile Compounding, the Cleanroom Technician ensures compounding is performed based on standard Operating Procedures including environmental monitoring. The Cleanroom Technician is responsible for preparing medications, complete sterile compounding of Non-hazardous and hazardous medications in accordance with regulatory standards, disinfect equipment and controlled areas, perform sterility testing and monitor inventory.

DUTIES AND RESPONSIBILITIES

• Perform glove fingertip sampling/Media fill testing and other aseptic technique assessment as required, Compound sterile preparations in compliance with approved formulations, USP <797>, USP <800>regulatory requirements.

· Prepares sterile parenteral following appropriate aseptic technique

• Ensure accurate documentation of compounding activities including lot numbers, expiry dates, calculations, and Beyond Use Dates (BUDs).
• Ensure proper handling, containment, and workflow practices for hazardous drugs in accordance with USP <800> and NAPRA standards.
• Support cleanroom quality processes.

• Ensure accurate and timely completion of batch records, compounding logs, cleaning logs, and environmental monitoring documentation.

• Assists the Drug Preparation Premises manager and Sterile Compounding Supervisorin maintaining federal, provincial, and local laws, accrediting body standards.

· Must comply with the following:

i. Adherence to all relevant guidelines including the established Standard Operation procedures and all applicable regulatory requirements as set out by the Ontario College of Pharmacists

1. Ensure safe and appropriate storage of medications, including ambient and cold chain products.

· Maintain model standard of sterile Compounding in the Cleanroom and Anteroom

· Perform all Cleanroom Technician tasks as required in accordance with regulations.

· Maintain daily environmental monitoring.

· Retain Cleanroom standards through cleaning and disinfection protocols.

· Perform daily (AM and PM), weekly and monthly cleaning of the clean, Anteroom and adjacent areas.

· Perform housekeeping of cleanroom and adjacent areas (check, storage, transition, change room & Lab)

· Perform stocking/restocking of medication and supplies as per SOPs.

· Follow the operational workflow and assigned tasks.

· Assist the pharmacist or designate in performing physical count of medication and supplies, as needed.

· Assist the pharmacist or designate in inventory management.

· Performs sterility testing in accordance with policy, maintains appropriate documentation.

· Assists the Pharmacist or designate in preparing compounding sheets for the preparation of medication.

· Complete the daily, weekly, monthly, and occasional logs in timely manner.

· Assists the Pharmacist or designate in the preparation and labeling of medications as allowed by law.

· Other duties, as assigned

QUALIFICATIONS

Education

· Must be enrolled in Registered Pharmacy Assistant Program or equivalent program.

· Certification as a Registered Pharmacy Assistant is preferred

· 1 year experience in Sterile compounding is required.

Physical Demands & Work Environment

The physical demands and work environment characteristics described below are representative of those required to successfully perform the essential functions of this role.

· Work is performed in a sterile cleanroom environment, requiring strict adherence to established protocols, including frequent cleaning and disinfecting activities throughout the shift, in accordance with standard operating procedures.

· The role involves physical activity, including prolonged periods of standing and walking, as well as bending, crouching, and sitting as required to complete assigned duties.

· The role requires repetitive use of the upper extremities, including frequent use of hands for tasks involving pinching, gripping, fine motor control, and handling materials and equipment.

· Duties include manual material handling, such as lifting, pushing, and pulling items weighing up to 50 lbs, including lifting from floor to waist and waist to shoulder as required.

· The role requires the ability to safely climb ladders and work at elevated heights when required for cleaning, maintenance, or material handling activities.

· Specific visual requirements are necessary to safely and accurately perform job duties, including close vision, distance vision, colour vision, depth perception, and the ability to adjust focus, particularly in a sterile compounding and production environment.

· The role requires the ability to wear required cleanroom personal protective equipment (PPE), including gowning, for extended periods of time while performing assigned duties.

· The work environment may involve exposure to chemicals used in cleaning, disinfecting, and operational processes, handled in accordance with established safety procedures and training.

· The employee may be occasionally exposed to fumes or airborne particles consistent with a controlled cleanroom or production environment.

· The noise level in the work environment is typically moderate.