Job Summary :
The Senior CSV Engineer – Project Lead is responsible for leading and executing Computer System Validation (CSV) activities for GxP-regulated systems, with a strong focus on Electronic Batch Record (EBR) platforms. This role provides both technical and project leadership across the full validation lifecycle, ensuring compliance with FDA and global regulatory requirements while delivering projects on time and within defined scope.

The position works closely with cross-functional teams including Quality, IT, Manufacturing, Automation, and external vendors to support system implementations, upgrades, and continuous improvement initiatives.


Roles & Responsibilities:

Lead and manage end-to-end CSV activities for GxP-regulated systems, with primary ownership of EBR platforms.

Plan, execute, and review validation deliverables including URS, FRS, risk assessments, IQ/OQ/PQ, and validation reports.