Aseptic Operator

About the Role

The Aseptic Operator supports sterile pharmaceutical manufacturing by performing cleanroom sanitization, equipment and parts preparation, aseptic setup support, and controlled documentation activities in accordance with SOPs, cGMP requirements, and production schedules. This role works in ISO-classified cleanrooms and controlled manufacturing areas where strict gowning, aseptic behavior, attention to detail, and documentation accuracy are essential.

Key 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, parts, components, and materials used in sterile manufacturing operations.
• Assist with basic equipment setup, line clearance, component transfers, and in-process checks under supervision or according to assigned qualification level.
• Support 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, safety, PPE, and chemical-handling 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 & Tech Stack

• Ability to read, understand, and follow SOPs, batch records, forms, and written instructions.
• Strong attention to detail and ability to complete accurate, timely, and legible documentation.
• Ability to obtain and maintain aseptic gowning qualification.
• 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.
• Basic computer proficiency, including Microsoft Outlook, Word, and Excel; experience with electronic quality systems such as MasterControl is a plus.
• Strong teamwork, communication, reliability, and willingness to work in a highly controlled manufacturing environment.

Qualifications

• High school diploma or equivalent required.
• Associate’s degree in Science, Engineering, Biotechnology, Pharmaceutical Manufacturing, or a related field preferred.
• Entry-level candidates are welcome to apply; prior pharmaceutical or cleanroom experience is not required for Aseptic Operator I placement.
• Prior experience in cGMP manufacturing, sterile manufacturing, cleanroom operations, aseptic processing, sanitization, or regulated production is strongly preferred.
• Experience with documentation, logbooks, batch records, cleaning records, or other controlled forms is beneficial.
• Must be able to learn and consistently follow aseptic behaviors, cleanroom practices, SOPs, documentation requirements, and safe equipment-handling procedures.

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (M-F 7:00 am - 4:00 pm)