Aseptic Equipment Operator I

Job Description

Aseptic Manufacturing Operator I

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 Manufacturing Operator I supports sterile manufacturing operations by performing aseptic cleaning, sanitization, and equipment preparation within ISO-classified cleanrooms. Working under direct supervision, this role assists with assembling, staging, and basic operation of manufacturing equipment in compliance with cGMP standards and data-integrity expectations. The Operator I ensures production areas remain in a continuous state of readiness and plays a key part in maintaining a clean, compliant, and safe aseptic environment.

Key Responsibilities:

• Perform routine and terminal sanitization of rooms, corridors, equipment, and parts in accordance with approved SOPs while aseptically gowned.

• Clean, assemble, and stage components and equipment for use with vial washers, depyrogenation tunnels, autoclaves, compounding vessels, aseptic fillers/cappers, and packaging lines.

• Assist operators with equipment setup, component transfers, line clearance, and in-process checks under supervision.

• Accurately complete logbooks, cleaning records, and controlled forms in alignment with Data Integrity (ALCOA+) principles.

• Handle disinfectants and chemicals safely; prepare and apply sanitizing solutions per instructions and dispose of waste per procedure.

• Maintain inventory of gowning supplies, disinfectants, wipes, and consumables within cleanroom areas; communicate shortages to supervision.

• Participate in required training and qualifications, including initial and periodic aseptic gowning qualification and media-fill support.

• Identify and immediately report equipment issues, spills, deviations, or unsafe conditions to supervision.

• Support internal and regulatory audits by maintaining accurate documentation and providing records as requested.

• Adhere to all PPE, safety, and cleanroom behavioral standards while sustaining good housekeeping and 5S practices.

• Perform additional duties as assigned to support production and compliance needs.

What We’re Looking For

Experience: Entry-level; 0–2 years of experience in cGMP manufacturing, cleanroom operations, or janitorial sanitization preferred.

Education: High school diploma or equivalent required; Associate’s degree in Science, Engineering, or related field preferred.

Skills & Knowledge:

• Understanding of aseptic techniques, cleanroom behaviors, and cGMP documentation practices.

• Ability to learn and maintain aseptic gowning qualification and proper cleanroom conduct.

• Attention to detail in following SOPs and completing accurate, legible records.

• Capability to work safely with disinfectants, autoclaves, washers, and other process equipment (training provided).

• Basic computer proficiency (Outlook, Word, Excel); familiarity with electronic quality systems (e.g., MasterControl) is a plus.

• Strong teamwork, reliability, and communication skills to operate effectively in a regulated environment.

• Flexibility to work assigned shifts, weekends, and overtime based on production demands.

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 day-shift position. Flexibility required for overtime, weekend coverage, and occasional off-shift support to meet production and cleaning schedules.Company Description

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.

Full-time