Validation Engineer

Cornerstone understands the importance of delivering our SaaS solutions in a quality-oriented manner that meets the regulatory and business expectations of our clients. This includes Life Sciences, Banking and Financial Services, Manufacturing, Healthcare, Government, etc. In software engineering, verification and validation (V&V) is the process of checking that a software system meets specifications and that it fulfills its intended purpose. The Principal V&V Specialist is a critical role for ensuring that Cornerstone meets and demonstrates these processes to our regulated clients. This role reports to the Head of Quality within the Quality and Risk Management (QRM) organization.

The Quality and Risk Management team owns the overarching Quality Management System at Cornerstone. This includes, but is not limited to:

Regulatory expertise, consulting, and oversight to all functional areas within Cornerstone
Audit Management
Learning and Development Management
Document Management
Deviation Management
Quality Plan and CAPA Management
Independent Verification and Validation Management (regulated industry clients).

QRM promotes awareness and provides updates to the IT System Development Life Cycle (SDLC) throughout IT and strives to ensure that the Cornerstone Solution is compliant to the level of quality that consistently meets or exceeds business needs and regulatory requirements. These responsibilities are further defined in the overall Cornerstone IT Quality Management System (IT QMS) and carried out within the Cornerstone IT Quality Manual.

The Validation Engineer will be responsible for providing a software Computer System Validation (CSV) package that provides documentary evidence of the verification and validation activities performed during the development, release, and maintenance of the Cornerstone Solution.

In this role you will...

General Requirements:

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