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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Essential Duties and Responsibilities: 

Sterile Filling & Operations

Ø Perform aseptic filling of injectable pharmaceuticals in cleanroom environments (ISO 5, ISO 7).

Ø Operate and monitor sterile filling equipment (e.g., filling machines, cappers, and autoclaves).

Ø Conduct manual and automated sterile filling processes according to batch records and SOPs.

Ø Support environmental monitoring by maintaining strict aseptic technique.

Ø Participate in line clearance, equipment set-up, in-process checks, and end-of-run reconciliation.

Compliance & Documentation

Ø Complete all batch records, logbooks, and electronic documentation in real time and with accuracy.

Ø Adhere to FDA 503B regulations, cGMP, and internal quality policies.

Ø Report deviations, non-conformances, or potential quality issues to supervision immediately.

Ø Support regulatory inspections and internal audits as needed.

Cleanroom & Equipment Maintenance

Ø Follow gowning procedures and aseptic practices required for sterile areas.

Ø Assist in cleaning, sanitizing, and maintaining cleanroom areas and equipment.

Ø Perform equipment setup, operation, and minor troubleshooting under supervision.

Teamwork & Continuous Improvement

Ø Work collaboratively with Production Scheduling, Sterile Room, Quality, Microbiology, Engineering, and other Manufacturing teams to ensure smooth sterile production runs.

Ø Participate in ongoing training programs to maintain qualifications for cleanroom operations.

Ø Suggest process improvements to enhance efficiency, safety, and compliance.

Supplemental Functions: 

Ø Performs all other duties as assigned or apparent.

Job Specifications and Qualifications: 

Education / Experience:

Ø High School Diploma or GED required; Associate or Bachelor's in Life Sciences preferred.

Ø Minimum 12 years' experience in sterile pharmaceutical manufacturing, 503B outsourcing, or hospital compounding strongly preferred.

Ø Familiarity with cGMP, FDA 503B guidance, and aseptic technique required.

Skills & Competencies:

Ø Strong knowledge of sterile gowning and aseptic technique.

Ø Ability to work in controlled cleanroom environments.

Ø Excellent attention to detail, documentation accuracy, and adherence to SOPs.

Ø Strong teamwork and communication skills.

Licensing and Certifications:

Ø Registered Pharmacy Technician Certification

Ø Ability to maintain Gowning Certification

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Working Conditions / Physical Requirements:

Ø Work performed primarily in classified cleanroom environments with strict gowning requirements.

Ø Ability to lift up to 40 lbs and stand for extended periods.

Ø Requires routine handling of sterile materials, chemicals, and equipment. 

Ø Shift work, weekends, and overtime may be required based on production demands.

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