Computer System Validation (CSV) Engineer

Job Description Summary: This role is ideal for an experienced Computerized Systems Validation (CSV) professional with 5–7+ years of experience in regulated pharmaceutical, biotech, or medical device manufacturing. The position focuses on validating and maintaining compliant computerized systems, ensuring data integrity and regulatory compliance, while collaborating with Automation, IT, and Quality teams to support audits and system lifecycle management.

Key Responsibilities

• Validation Lifecycle Management: Lead the lifecycle validation activities for computerized systems, including automated production equipment, DBR, DCS, BMS, and FMS. Compile, review, and execute validation blueprints, including User Requirement Specifications (URS), Functional Specifications (FS), Risk Assessments, and Validation Plans.
• Protocol Execution & Testing: Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (...