🛠 Tech Stack

💼 About This Role

You'll lead validation activities for cloud-based GxP systems at a clinical-stage vaccine company. Your work will ensure regulatory compliance for manufacturing and lab data systems.

🎯 What You'll Do

• Author and execute validation documents and protocols for GAMP 5 systems.
• Perform risk assessments to define validation scope and testing strategy.
• Assess end-to-end data flows for accuracy, completeness, and traceability.
• Support change control, deviation management, and periodic review.

📋 Requirements

• Bachelor's degree in Computer Science, Engineering, or related field.
• Minimum 7 years experience in Computer System Validation within biotech.
• Strong hands-on experience validating GAMP 5 systems for biotech manufacturing.
• Deep understanding of FDA 21 CFR Part 11 and data integrity requirements.

✨ Nice to Have

• Hands-on experience validating Azure cloud GxP systems.
• Familiarity with infrastructure as code frameworks like GitHub, Terraform.

🎁 Benefits & Perks

• 🏖️ Comprehensive benefits including equity component.
• 💰 Competitive salary range $164,000 - $190,000.