Description

Own Computer System Validation (CSV) activities for GxP applications, laboratory systems, manufacturing platforms, and enterprise solutions.

This role is hybrid.

Responsibilities

• Execute CSV activities and develop validation documentation including Validation Plans, Risk Assessments, URS, Functional/Design Specifications, Test Scripts (IQ/OQ/PQ), Traceability Matrices, and Summary Reports.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q7/Q10, and company SOPs.
• Perform risk-based assessments to prioritize validation testing and support data integrity assessments and remediation.
• Collaborate with QA, IT, Manufacturing, R&D, and Business Units to ensure timely validation delivery and provide audit support for regulatory inspections.
• Train project teams on CSV processes, documentation standards, and compliance requirements while supporting continuous improvement of procedures.

Required Skills

• 7+ years of experience in software engineering or validation roles.
• Deep knowledge of GxP environments, CSV lifecycles, and regulatory frameworks (FDA, EU Annex 11, GAMP 5).
• Proficiency in Agile methodologies.
• Experience with cloud platforms, specifically AWS and Azure.
• Familiarity with Veeva systems or similar life sciences platforms.
• Strong ability to write and review technical documentation and test scripts.

Key Skills

Education

Any Gradute