Sr. Computer System Validation Specialist

Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa. 

Job Description:

Responsible for the computerized system validation and data integrity at the plant site. 

The job functions include periodic review and audit trail reviews. Drafting, reviewing, and executing equipment-specific test plans. 

Drafting and reviewing user requirement specifications, risk assessments, traceability matrix, and qualification protocols – including test plans and acceptance reports. 

This person ensures the site’s data integrity strategy is sound and incoming systems are appropriately qualified and requalified to meet 21CFR and EMA Annex 11 requirements.

 Perform Periodic Reviews and Audit Trail Reviews of computerized systems.

Write and review documents to support the qualification of a computerized system.
Validation Plan
User Requirements Specification
Risk Assessment
Traceability Matrix
Qualification Protocol
Qualification Test Plan
Qualification Acceptance Report
Validation Plan Acceptance Report
Write and manage change control documents for computerized systems and assist with change controls for production computerized systems as necessary.
Write and review CSV SOPs.
Partner with other departments to ensure the site is compliant.
Provide support for computerized systems and data integrity strategy during audits, deviations, and investigations.