Aseptic Operator I

Penn Life Sciences; Langhorne (Bucks County); On-site; USD 35,000 - 50,000; Full time

Benefits offered by this job

401(k) with company match

Health, vision, and dental insurance

Childcare expense reimbursement

Tuition reimbursement

Annual bonus eligibility

Paid Time Off and Flexible Holidays

Job summary

Penn Life Sciences is seeking an Aseptic Operator I to join our team in Langhorne, PA. This entry-level role supports sterile manufacturing operations by performing cleanroom sanitization, equipment preparation, and documentation activities.

Ideal candidates must have a high school diploma, strong attention to detail, and a willingness to learn aseptic practices in a regulated environment. The position offers benefits like health insurance, a 401(k) match, and tuition reimbursement.

Qualifications

• Entry-level candidates are welcome to apply; prior pharmaceutical or cleanroom experience is not required.
• Ability to obtain and maintain aseptic gowning qualification.
• Ability to safely work with disinfectants, cleaning agents, and manufacturing equipment.

Responsibilities

• Perform cleanroom sanitization and prepare equipment for sterile manufacturing.
• Complete logbooks and cleaning records in compliance with cGMP.
• Report equipment issues, alarms, and unsafe conditions to supervision.

Skills

Attention to detail

Basic computer proficiency

Understanding of cGMP

Education

High school diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

MasterControl

Job description

Penn Life Sciences is seeking an Aseptic Operator I to join our team in Langhorne, PA.

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.

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

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

Penn Life Sciences is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.