Sterile Room Technician (Tier I)

Description

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.

Essential Duties and Responsibilities:

Tier I - Entry Technician

• Perform basic aseptic gowning and maintain cleanroom discipline in ISO 5-ISO 8 areas.
• Assist in material and component preparation, staging, and transfer into cleanroom.
• Clean and sanitize production equipment and classified areas per SOPs.
• Support line set-up under close supervision.
• Perform basic in-process checks (e.g., environmental monitoring plate placement, line clearance).
• Accurately complete batch records and logbooks with guidance.
• Identify and report deviations or potential contamination risks immediately.
• Follow all gowning, hygiene, and personnel flow procedures strictly.

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.

Working Conditions / Physical Requirements:

• Standing for long periods in cleanroom PPE.
• Lifting up to 40 lbs.
• Ability to work in classified cleanroom environments for extended shifts.
• Shift work, weekends, and overtime may be required.