Aseptic Operator I/II

Job Description

Job Description

Aseptic Operator I/II

About Penn Life Sciences

Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.

What You’ll Do

The Aseptic Operator I/II 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.

Candidates may be placed at the Aseptic Operator I or Aseptic Operator II level based on demonstrated experience, aseptic gowning qualification, cleanroom readiness, and ability to perform sterile manufacturing activities with the appropriate level of supervision.

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.
• Candidates with active or prior aseptic gowning qualification, cleanroom manufacturing experience, or independent sterile processing experience may be considered for Aseptic Operator II placement.
• 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
• 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)

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

Company Description

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.