Sterile Manufacturing Operator
On-siteHouston, Texas, United States
Job Summary
Execute aseptic production processes for compounded medications using validated techniques and gowning procedures while maintaining accurate batch records and electronic documentation. Operate, clean, and maintain sterile manufacturing equipment including isolators and cleanroom systems to ensure calibration compliance and consistent performance. Identify and document deviations, non-conformances, and quality events to support root-cause investigations and corrective actions in alignment with FDA, USP, and internal quality requirements. Conduct cleanroom monitoring activities and environmental sampling to maintain compliance with environmental standards, utilizing AI-enabled trend analysis tools to identify emerging risks. Optimize production schedules efficiently to meet output targets while reducing waste and enhancing manufacturing performance through continuous improvement initiatives. Partner with Quality, Maintenance, and Production teams to resolve issues and support seamless operations across functions within a fast-paced, highly regulated environment.
Required Qualifications
- High school diploma or equivalent
- Knowledge of aseptic processing
- Knowledge of cleanroom behavior
- Knowledge of contamination-control practices
- Ability to follow SOPs with precision
- Ability to maintain strong documentation accuracy
- Familiarity with cGMP requirements
- Familiarity with FDA regulations
- Familiarity with sterile manufacturing environments
- Basic data literacy
- Ability to use AI-enabled tools to support operational insights and decision-making
- Comfort working in cleanroom environments
- Ability to comply with aseptic gowning requirements
- Ability to talk
- Ability to hear
- Ability to remain in a stationary position for a significant amount of the workday
- Ability to use hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices
- Ability to move about the office and around the corporate campus
- Ability to stand
- Ability to walk
- Ability to reach with arms and hands
- Ability to climb or balance
- Ability to stoop, kneel, crouch or crawl
Desired Qualifications
- Technical training
- Experience in sterile manufacturing
- Experience in compounding
- Experience in another regulated production environment
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