Sterile Room Technician (Tier I)

NEPHRON SC, LLC • West Columbia, SC

8d

About The Position

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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 251-500 employees