Sterile Room Technician (Tier I)

Job Purpose: The Sterile Room Technician supports aseptic manufacturing operations in a controlled cleanroom environment, ensuring the production of sterile pharmaceutical products in compliance with GMP, SOPs, and regulatory requirements. The position is tiered into three levels based on experience, skills, and independent decision-making authority.

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Essential Duties and Responsibilities: 

• Tier 1 – Entry Technician (Material Transfer)
•  Follow all hygiene, gowning and cleaning procedures. 
• Perform and maintain personal gowning certification. Retrieve material and consumables from warehouse or storage locations.
•  When require prepare cleaning solutions safely and as per SOPs.
•  Clean and sanitize production material and consumables as SOPs.
•  Clean and sanitize production equipment as per SOPs.
•  Ensure material and equipment are transferred in a timely matter.
•  Communicate and assists other departments when necessary to process materials, supplies and equipment by priority.
•  Accurately record all cleaning and sanitization activities in the corresponding cleaning logs.
•  Support other material entries room as needed.
•  Stock and replenish inside cleanroom materials to ensure continuous production support.
•  Stock and replenish all outside materials as per the area’s requirements.
•  Assist in performing entry level cleanroom cleaning/ sanitization activities to support production.
•  Address any discrepancies immediately by escalate to supervisor or management any incidents, accident or alarms.
•  Ensure to empty all garbage containers and dispose accordantly and as required through the shift.
•  Assist with issuing and returning to stock cleanroom shoes when required.
•  Maintain personal SOP training current as per company requirement and cGMP.
•  Assist with deviation investigations, root cause analysis, and CAPA implementation.
• Requirements:
•  High school diploma or GED.
•  0–1 year of manufacturing or cleanroom experience (pharma/medical device preferred).
•  Basic understanding of aseptic technique and GMP.
•  Ability to follow written and verbal instructions precisely.
• Supplemental Functions:
•  Performs all other duties as assigned or apparent.
• Job Specifications and Competencies: 
•  Strict adherence to aseptic technique.
•  Attention to detail and accuracy in documentation.
•  Teamwork and communication skills.
•  Commitment to product quality and patient safety.