Full Description

Job Title: Computer System Validation (CSV) Engineer

Location: Onsite – North Carolina

Duration: Fulltime

Engagement Type: Contract | Full-Time Onsite

Industry: Pharmaceutical CDMO Job Description We are seeking an experienced Computer System Validation (CSV) Engineer to support a short-term remediation project at a pharmaceutical CDMO in South Carolina. This engagement is focused on closing remaining software-related compliance gaps and CAPAs. This is a hands-on, execution-focused role requiring a consultant who can hit the ground running with minimal training or guidance from the client. The ideal candidate has strong CSV execution experience in regulated environments and can quickly deliver compliant documentation and remediation outcomes. Key Responsibilities Execute CSV activities to remediate software compliance gaps and CAPAs Review, update, and execute validation documentation and protocols Perform validation of PLC- and SCADA-based systems Ensure compliance with 21 CFR Part 11 and applicable GxP requirements Support deviation resolution and remediation documentation Work independently onsite to meet aggressive remediation timelines Required Qualifications 5+ years of experience in Computer System Validation within a regulated pharmaceutical environment Bachelor’s degree (BS) required Strong working knowledge of 21 CFR Part 11 Hands-on experience validating PLC/SCADA-based systems Excellent documentation and execution skills