Aseptic Operator

Penn Life Sciences; Philadelphia (Philadelphia County); On-site; USD 25,000 - 36,000; Full time

Benefits offered by this job

Performance bonus eligibility

401(k) with company match

Medical, dental, vision, and life 보험

Career growth opportunities

Tuition reimbursement for children

Childcare expense reimbursement

Job summary

Penn Life Sciences, Inc. is seeking an Aseptic Operator to support sterile pharmaceutical manufacturing in ISO-classified cleanrooms. You will perform cleanroom sanitization, equipment preparation, aseptic setup, and maintain compliant documentation.

Entry-level candidates are welcome; prior experience is preferred but not required. The role emphasizes strict gowning, cGMP adherence, and accurate record-keeping to ensure product quality and patient safety.

Qualifications

• Aseptic and cleanroom practices; follow SOPs, batch records, forms.
• Ability to obtain aseptic gowning qualification.
• Willingness to learn cGMP and data integrity practices.
• Comfort with basic computer tools and documentation systems.

Responsibilities

• Sanitize cleanrooms and controlled areas per SOPs.
• Prepare, stage, wash, rinse, dry, and transfer equipment and materials.
• Assist with equipment setup, line clearance, and transfers.
• Support autoclaves, vial washers, and other processing equipment.
• Complete logbooks and records with accuracy and timeliness.
• Adhere to cGMP, gowning, PPE, and safety requirements.
• Report equipment issues or deviations promptly to supervision.
• Participate in training and continuous improvement activities.

Skills

SOPs literacy

Detail oriented

Gowning qualification

cGMP knowledge

Documentation accuracy

Basic computer skills

Teamwork

Education

High school diploma

Associate degree preferred

Tools

MasterControl

Job description

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.

What We’re Looking For

Experience

• 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.

Education

• High school diploma or equivalent required.
• Associate’s degree in Science, Engineering, Biotechnology, Pharmaceutical Manufacturing, or a related field preferred.

Skills & Knowledge

• 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 in accordance with site requirements.
• 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.

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
• Comprehensive medical, dental, vision, and life insurance coverage
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement