Sterile Filling Technician

Essential Duties and Responsibilities

• 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).
• Congduct 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:
• A High School Diploma or GED required.
• An 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.

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.