Roles & Responsibilities:

Generate and/or support on the generation of lifecycle documentation, including but not limited to system/risk assessments, URS, specifications, etc.
Route for approval lifecycle documentation.
Generate and route for approval Validation Plan, and Test Plan for the computerized systems.
Generate and route for approval the Test Scripts required for the computerized systems.
Execution and routing for post-approval of the Test Scripts required for the computerized systems.
Generate and route for approval of issues/discrepancies as a result of test scriptsexecution.
Support engineering, automation, and system owners in the issues/discrepancies resolution, and corrective actions.
Update lifecycle documentation as needed per issues/discrepancies result.
Generate and route for approval the Test Summary and Final Validation s as required.
Maintain training current on relevant SOPs.
Daily accounting of time and activities submitted to Validation Lead/PM weekly Requirements
Bachelor degree in engineering, science or related field.
At least 5 years of experience in CSV activities for Pharmaceutical Industries.
Primarily experience in Factory talk view site edition (FTView SE) from Rockwell automation.
Should have good experience in Automation design.
Should also have experience in automation embedded in equipment. (Level 2,Level 3 systems)
SCADA experience is a MUST.
Experience in reviewing design documents like BOM, Automation / electrical panel, FDS, HDS etc.

Katalyst Healthcares & Life Sciences Hiring for CSV Engineer at Sanford, NC Full Time

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