Sterile Filling Technician

Nephron Pharmaceuticals Corporation; West Columbia (SC); On-site; USD 42,000 - 62,000; Full time

Job summary

Nephron Pharmaceuticals Corporation in West Columbia, SC is hiring a Sterile Filling Technician to perform aseptic filling and related sterile operations within a 503B outsourcing pharmaceutical facility, ensuring FDA 503B regulations and cGMP standards are followed to safeguard product quality and patient safety.

Responsibilities include operating sterile filling equipment, maintaining aseptic technique, and completing batch records in real time. Shift work and ongoing training are possible.

Qualifications

• High school diploma or GED required; Life Sciences degree preferred.
• 1–2 years of sterile pharmaceutical manufacturing experience preferred in 503B outsourcing or hospital compounding.
• Familiarity with cGMP and FDA 503B guidance; aseptic technique required.

Responsibilities

• Perform aseptic filling of injectable pharmaceuticals in cleanrooms (ISO 5/7).
• Operate sterile filling equipment (filling machines, cappers, autoclaves).
• Complete batch records and electronic logbooks in real time.
• Maintain aseptic technique; support environmental monitoring and audits.
• Collaborate with QA, Microbiology, Engineering and Production teams.

Skills

Aseptic technique

Sterile gowning

Documentation accuracy

Teamwork

Clear communication

Education

High school diploma or GED

Life Sciences degree preferred

Job description

Description

Job Purpose:

The Sterile Filling Technician is responsible for performing aseptic filling and related sterile operations within a 503B outsourcing pharmaceutical manufacturing facility. This role ensures products are prepared, filled, and packaged in compliance with FDA 503B regulations, cGMP standards, and company SOPs to ensure product quality and patient safety.

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Sterile Filling & Operations

• Perform aseptic filling of injectable pharmaceuticals in cleanroom environments (ISO 5, ISO 7).
• Operate and monitor sterile filling equipment (e.g., filling machines, cappers, and autoclaves).
• Conduct manual and automated sterile filling processes according to batch records and SOPs.
• Support environmental monitoring by maintaining strict aseptic technique.
• Participate in line clearance, equipment set-up, in-process checks, and end-of-run reconciliation.

Compliance & Documentation

• Complete all batch records, logbooks, and electronic documentation in real time and with accuracy.
• Adhere to FDA 503B regulations, cGMP, and internal quality policies.
• Report deviations, non-conformances, or potential quality issues to supervision immediately.
• Support regulatory inspections and internal audits as needed.

Cleanroom & Equipment Maintenance

• Follow gowning procedures and aseptic practices required for sterile areas.
• Assist in cleaning, sanitizing, and maintaining cleanroom areas and equipment.
• Perform equipment setup, operation, and minor troubleshooting under supervision.

Teamwork & Continuous Improvement

• Work collaboratively with Production Scheduling, Sterile Room, Quality, Microbiology, Engineering, and other Manufacturing teams to ensure smooth sterile production runs.
• Participate in ongoing training programs to maintain qualifications for cleanroom operations.
• Suggest process improvements to enhance efficiency, safety, and compliance.

Supplemental Functions

• Performs all other duties as assigned or apparent.

Job Specifications and Qualifications

Education / Experience

• High School Diploma or GED required; Associate or Bachelor’s in Life Sciences preferred.
• Minimum 1–2 years’ experience in sterile pharmaceutical manufacturing, 503B outsourcing, or hospital compounding strongly preferred.
• Familiarity with cGMP, FDA 503B guidance, and aseptic technique required.

Skills & Competencies

• Strong knowledge of sterile gowning and aseptic technique.
• Ability to work in controlled cleanroom environments.
• Excellent attention to detail, documentation accuracy, and adherence to SOPs.
• Strong teamwork and communication skills.

Licensing and Certifications

• Registered Pharmacy Technician Certification
• Ability to maintain Gowning Certification

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Working Conditions / Physical Requirements

• Work performed primarily in classified cleanroom environments with strict gowning requirements.
• Ability to lift up to 40 lbs and stand for extended periods.
• Requires routine handling of sterile materials, chemicals, and equipment.
• Shift work, weekends, and overtime may be required based on production demands.