Job Description

Responsibilities and Requirements:

We are seeking an experienced Computer System Validation (CSV) Engineer to join our team for an onsite project in Texas.

The role involves validating the Meridian Electronic Document Management System (EDMS) to ensure compliance with regulatory standards and company quality policies.

Develop and execute validation protocols (IQ/OQ/PQ) for Meridian EDMS.

Ensure that the system meets all regulatory requirements, including 21 CFR Part 11.

Collaborate with cross-functional teams including QA, IT, and system users to gather requirements and ensure thorough validation.

Document all validation activities and prepare validation summary reports.

Troubleshoot and resolve validation issues, ensuring the system is operating as intended.

Provide training and support to end-users on validated systems.

Experience with Meridian EDMS (Bluecielo also acceptable).

Bachelor's degree in Computer Science, Engineering, or related field.

3+ years of experience in computer system validation, in pharma/biotech industries.

Strong knowledge of regulatory requirements (FDA, GxP, 21 CFR Part 11).

Excellent communication and documentation skills.

Job Tags

Permanent employment,

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