Aseptic Manufacturing Operator - AI-Driven Quality & Growth

Empower Pharmacy; Houston (TX); On-site; USD 52,000 - 78,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid time off

401(k) matching

Job summary

Empower Pharmacy seeks a Sterile Manufacturing Operator to execute aseptic production processes in a regulated 503A/503B environment, ensuring precise batch execution, traceability, and contamination control using AI-enabled systems.

You will handle gowning, equipment cleaning, and maintaining quality documentation, while supporting ongoing process improvements and compliance with FDA, USP, and cGMP standards.

Qualifications

• Knowledge of aseptic processing, cleanroom behavior, and contamination-control practices.
• Ability to follow SOPs with precision and maintain strong documentation accuracy.
• Familiarity with cGMP requirements, FDA regulations, and sterile manufacturing environments.
• Basic data literacy with the ability to use AI-enabled tools to support operational insights and decision-making.

Responsibilities

• Perform sterile compounding and/or filling using validated aseptic techniques in compliance with SOPs and cGMP requirements.
• Maintain accurate batch records and electronic documentation, leveraging AI-enabled systems.
• Perform aseptic gowning and equipment cleaning to support sterile processing activities.
• Operate, clean, and maintain sterile manufacturing equipment, including isolators and cleanroom systems.

Skills

Aseptic processing

Cleanroom

Documentation

cGMP

FDA regulations

AI-enabled tools

Education

High school diploma or equivalent

Tools

AI-enabled systems

Job description

Empower Pharmacy seeks a Sterile Manufacturing Operator to execute aseptic production processes in a regulated 503A/503B environment, ensuring precise batch execution, traceability, and contamination control using AI-enabled systems.

You will handle gowning, equipment cleaning, and maintaining quality documentation, while supporting ongoing process improvements and compliance with FDA, USP, and cGMP standards.