Aseptic Operator I

About the role

The Aseptic Operator I will support sterile manufacturing operations by performing cleanroom sanitization, equipment and parts preparation, basic setup support, and controlled documentation activities in accordance with SOPs, cGMP requirements, and production schedules. This is an entry-level sterile manufacturing role designed for candidates who can learn and consistently apply aseptic behaviors, gowning practices, Good Documentation Practices, and cleanroom expectations in a highly regulated pharmaceutical environment.

Responsibilities

• Perform routine and terminal sanitization of cleanrooms, corridors, equipment, parts, and controlled manufacturing areas in accordance with approved SOPs.
• Prepare, stage, wash, rinse, dry, wrap, load, and transfer equipment, components, parts, and materials used in sterile manufacturing operations.
• Assist with basic equipment setup, line clearance, component transfers, and in-process checks under supervision.
• Support preparation activities for manufacturing equipment and process areas, including vial washer, depyrogenation tunnel, autoclaves, compounding equipment, aseptic filler/capper, automated inspection, and packaging operations.
• Accurately complete logbooks, cleaning records, use logs, forms, and other controlled documentation in compliance with Good Documentation Practices and Data Integrity expectations.
• Follow all cGMP, aseptic behavior, cleanroom conduct, gowning, PPE, chemical-handling, and safety requirements.
• Identify and immediately report equipment issues, alarms, spills, deviations, unsafe conditions, or documentation discrepancies to supervision.
• Participate in training, aseptic gowning qualification, media-fill support activities, audits, investigations, and continuous improvement activities as assigned.

Requirements

• High school diploma or equivalent required.
• Entry-level candidates are welcome to apply; prior pharmaceutical or cleanroom experience is not required.
• Prior experience in cGMP manufacturing, cleanroom operations, aseptic processing, sanitization, janitorial sanitization, or regulated production preferred.
• Ability to obtain and maintain aseptic gowning qualification in accordance with site requirements.
• Ability to read, understand, and follow SOPs, forms, batch records, cleaning records, and written instructions.
• Strong attention to detail and ability to complete accurate, timely, and legible documentation.
• Basic understanding of cGMP, Good Documentation Practices, cleanroom behavior, and Data Integrity principles preferred.
• Ability to safely work with disinfectants, cleaning agents, carts, racks, washers, autoclaves, tools, and manufacturing equipment after training.

Qualifications

• Basic computer proficiency, including Microsoft Outlook, Word, and Excel; experience with electronic quality systems such as MasterControl is a plus.

Skills

• None specified

Benefits

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays

Pay

N/A

Schedule

N/A