🛠 Tech Stack

💼 About This Role

You'll ensure GxP computerized systems are validated in compliance with regulatory standards for a gene therapy manufacturing company. You'll lead validation activities for key systems like Veeva QMS and BMRAM, directly impacting product quality and patient safety.

🎯 What You'll Do

• Author and execute validation deliverables for GxP computerized systems.
• Support CSV efforts for Veeva Vault QMS, BMRAM, and lab instruments.
• Perform risk assessments and ensure data integrity and audit trail review.
• Manage system change control, deviations, and CAPAs for validated systems.

📋 Requirements

• Bachelor's degree in Computer Science, Engineering, or Life Sciences.
• 2+ years in Computer System Validation within GxP regulated environment.
• Working knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11.
• Experience validating Veeva Vault QMS, BMRAM, or lab instrumentation.

✨ Nice to Have

• Experience with Veeva Vault platform configuration or validation.
• Hands-on validation of laboratory instruments like HPLC or UV-Vis.
• Familiarity with Metasys BMS or similar environmental monitoring systems.

🎁 Benefits & Perks

• 🏖️ Comprehensive benefits package designed to help you thrive.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical Interview· 60 min