Job Description

Associate Specialist providing technical engineering support for packaging and medical device assembly operations at a manufacturing site. Responsibilities include equipment troubleshooting, process qualification, product transfers, and quality documentation while coordinating with cross-functional teams.

Responsibilities

• Troubleshoot packaging and device assembly equipment problems on production lines
• Author quality incidents and support root cause analysis for equipment and process deviations
• Support technology transfer and new product introduction through process qualification activities
• Prepare and execute process change controls and equipment modifications
• Analyze equipment performance data and maintain process documentation for regulatory compliance

Requirements

• Bachelor's degree in Engineering or equivalent technical discipline
• Mechanical aptitude and equipment troubleshooting capability
• Strong technical communication and documentation skills
• Project coordination and multi-priority management ability
• Pharmaceutical industry or GMP manufacturing experience preferred
• Medical device and combination product knowledge preferred
• Equipment qualification and vendor management experience preferred

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