Perform machine setup, tooling changes, and offset adjustments as required.
Conduct first article, in-process, and final inspections using precision measuring instruments such as vernier calipers, micrometers, and height gauges.
Troubleshoot machining issues and make necessary adjustments to maintain product quality.
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Collaborate with Engineering, Maintenance, and Validation to ensure timely calibration and validation of production equipment.
Stay informed on global regulatory requirements (FDA, EMA, PIC/S, ICH) for aseptic manufacturing and product introduction, and remain up to date on current Good Manufacturing Practices (cGMP).
Maintain aseptic filling rooms and ensure adherence to stringent requirements, with flexibility for the execution during off-hours.
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