Overview

The Computer Systems Validation (CSV) Sr Specialist ensures that all manufacturing machines, equipment, laboratory instruments, and site utilities comply with GxP regulations and 21 CFR Part11 requirements. This role focuses on preventing data manipulation by establishing rigorous technical controls across the entire site lifecycle.

Key Responsibilities

• Part 11 Technical Controls User Access: Enforce unique user IDs and restrict administrative privileges to non‑production personnel.
• Audit Trails: Verify that automated audit trails capture the who, what, when and why of all data modifications.
• Data Backup: Implement and test automated secure backup and archival processes to prevent data loss.
• Security Levels: Map out and restrict system access based strictly on defined operational roles.
• CSV Risk Assessment for Equipment Oversight: Assess production machines and instr...