Job Details:
Position involves support of senior staff in the initiation design and delivery of projects particularly for the Combination Product Operations MST - Physical Sciences and Engineering PSE organization.Responsibilities include development and lifecycle management of Physical GMP Test Methods lifecycle management of integrated testing machines development and validation of test methods.The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation.Assist with project definition by performing engineering studies and assessment for automated test systems installations.Perform field evaluations of existing systems and provide engineering design recommendations.This individual has a passion for modeling analytics and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisionsPreferred Skills
- Experience working in a regulated industry exposure to GMPs
- Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
- Statistical analysis and knowledge of Gage RR
- Knowledge of Optical measurement devices force testers BLE testing
- Test method development CAD design Solidworks mechanical modeling
- Manufacturing experience IQ OQ and PQ
Preferred Traits:
- Passion for proactively identifying opportunities through creative data analysis and modeling
- Intellectual curiosity with ability to learn new concepts/frameworks algorithms and technology rapidly as needs arise
- Ability to manage multiple competing priorities simultaneously experience with MS Project
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