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Computer System Validation Analysts (12 Positions)

Location: Austin, TX

Duration: 2 Months+ (Contract)

Compensation: Hourly (DOE) +Expenses Paid

We are seeking to URGENTLY hire a team of onsite CSV Analysts for a contractual assignment for our esteemed medical devices client based in Austin, TX.

• Minimum of five years of experience in authoring and executing CSV test scripts, and creating validation summary reports
• Knowledge of GXP regulations and CFR 21 Part 11.
• Hands on experience drafting CSV test scripts (OQ, PQ), dry running test scripts, executing test scripts and creating test summary reports.
• Knowledge of Manufacturing Execution System (MES) preferred but not required
• Experience performing all administrative activities associated with the document revision process including revising, routing, reviewing and approving all documents in scope.
• Experience in logging defects during test execution, following up with appropriate parties to resolve defects and re-execute testing as necessary
• Experience using Requirement Specifications (URS, FS) to create test scripts
• Experience updating Traceability matrix and Test Summary report and Validation Summary reports.
• Strong written and verbal communication skills and experience working in fast paced environment.
• Excellent teamworking skills, including willingness and ability to consult with subject matter experts from engineering, manufacturing, and project management.
• Experience in Medical Devices industry preferred.