Aseptic Manufacturing Engineering Specialist
We are seeking an experienced professional to support and enhance aseptic manufacturing operations within a GMP-regulated environment.
About the Role:
The successful candidate will partner closely with various teams to ensure the highest standards of sterility assurance, safety, and operational performance.
Key Responsibilities:
* Act as Subject Matter Expert for aseptic manufacturing equipment, cleanrooms, and utility systems ensuring compliance with regulatory requirements and industry best practices.
* Maintain real-time monitoring of aseptic manufacturing systems including cleanroom performance (temperature, humidity), differential pressure airflow) and utility systems supporting aseptic operations.
* Investigate automation system alarms prioritizing appropriate alarm resolution trending system performance data developing action plans to address deviations or opportunities for improvement.
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