Computer System Validation (CSV) Specialist

Job Description:
The CSV Specialist will be responsible for ensuring that client computer systems meet regulatory requirements through structured validation processes. You will also work on Computer Software Assurance (CSA) projects.

Key Responsibilities:

• Develop validation protocols (IQ, OQ, PQ) and reports.
• Perform system risk assessments and compliance checks.
• Ensure systems comply with FDA 21 CFR Part 11, GxP, and data integrity standards.
• Provide client support during system audits and inspections.

Qualifications:

• Bachelor’s degree in Computer Science, Engineering, or related field.
• Experience with CSV, CSA, and regulatory compliance.
• Strong understanding of ALCOA+ principles.
• Familiarity with pharma/medical device environments.