Job description

We are seeking a highly experienced and detail-oriented FDA Computer System Validation (CSV) Lead to ensure compliance with FDA and other authorized body (TUV, BSI, etc.) regulations and guidelines for computer systems within our organization. As the CSV Lead, you will be responsible for overseeing the validation of computer systems used in the development, manufacturing, and distribution of FDA-regulated products. You will collaborate with cross-functional teams to develop and execute validation strategies, ensure documentation and testing protocols meet regulatory requirements, and drive the successful implementation of validated systems.

**What will you do:**

+ Lead and manage the end-to-end Computer System Validation (CSV) lifecycle, including planning, execution, documentation, and approvals.
+ Develop, review, and maintain CSV deliverables such as validation plans, protocols, risk assessments, traceability matrices, and final reports....