Job Description

General Purpose

We are seeking a skilled Quality Engineer to join our engineering team, focusing on calibration, validation, equipment qualification, process improvement, and vendor coordination. This role is essential for providing support to technicians and staff, enhancing infrastructure, and ensuring effective and timely engineering practices. The ideal candidate will contribute to improving efficiency across various areas.

Job Tasks and Responsibilities

• Equipment Calibration: Manage the tracking and scheduling of equipment calibration. Oversee the calibration management program and coordinate with vendors to ensure timely execution.
• Validation Management: Plan, track, and schedule validation activities. Approve and oversee validation protocols, and coordinate scheduling with third-party vendors.
• Change Control: Develop and implement change controls for managing change requests.
• Project Coordination: Collaborate with the engineering and quality departments to ensure project deadlines are met and maintain readiness.
• Continuous Monitoring: Continuously monitor, track, report, and maintain systems to ensure optimal performance.

Education and Experience

• Bachelor of Science in Mechanical Engineering or equivalent.
• 2+ years with mechanical experience or related projects.
• Excellent computer and critical thinking skills.
• Sterile Manufacturing in a pharmaceutical setting.

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