Job Description
Job Description:
The CSV Engineer will serve as an individual contributor responsible for ensuring compliance with industry regulations and standards while driving efficiency in site and process improvement projects. This role requires expertise in computer system validation, controls automation, and GMP documentation, with a focus on DeltaV and Syncade MES systems. The engineer will collaborate with the CSV team to identify roadblocks, assess risks, and implement best practices across critical systems.
The CSV Engineer will serve as an individual contributor responsible for ensuring compliance with industry regulations and standards while driving efficiency in site and process improvement projects. This role requires expertise in computer system validation, controls automation, and GMP documentation, with a focus on DeltaV and Syncade MES systems. The engineer will collaborate with the CSV team to identify roadblocks, assess risks, and implement best practices across critical systems.
Responsibilities
- Act as CSV owner for major site and process improvement projects.
- Conduct risk assessments of systems and processes.
- Review change requests, test scripts, and draft validation protocols.
- Initiate and review GMP documentation revisions.
- Execute QMS processes including:
- Change Control (DeltaV, Syncade MES) ...
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