Mangrum

Senior Engineer-Equipment Validation

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  • Fremont, CA, USA
  • 2021-09-27

Rapidly growing Medical Device company with major career opportunities.

The Equipment Validation Engineer is responsible for defining and executing validation strategy and coordinating validation activities required to launch new equipment into the production environment. The successful candidate will perform validation activities that include Equipment/Utility/Facility Qualification, Cleaning Validation, and Automation System Qualification across the entire validation lifecycle from Plan to Retire. Work with a cross functional team to support manufacturing capacity expansion projects.

REQUIREMENTS:

BS Engineering 

Experience with root cause analysis, process engineering, failure investigations and automated assembly equipment validation

Strong working knowledge of GMP, ISO, and FDA rules and regulatory requirements.

Strong data analysis skills utilizing software such as MiniTAB and JMP.