🛠 Tech Stack

💼 About This Role

You'll develop computer system validation protocols and execute test scripts in a GMP environment, ensuring compliance with 21 CFR Part 11. This role drives operational readiness for life sciences clients, requiring expertise in CSV and data integrity.

🎯 What You'll Do

• Develop and execute CSV protocols and test scripts
• Write GxP validation documentation (URS, FRS, RTM)
• Perform gap analysis and consult on remediation plans
• Ensure 21 CFR Part 11 compliance for automated systems

📋 Requirements

• BS in Computer Science, Engineering, or equivalent
• 2-7 years of CSV experience
• 2 years in a GMP environment
• Knowledge of GAMP and 21 CFR Part 11

✨ Nice to Have

• Experience with MES, Delta V, or PI
• Biotech or pharma background preferred
• Knowledge of Data Integrity and consent decree experience