🛠 Tech Stack

💼 About This Role

You'll lead Computer System Validation (CSV) activities for enterprise GxP systems in a Cell Therapy functional area. Your core impact involves ensuring deliverables and testing align with client CSV SOPs. This role stands out with AI accelerator tools to enhance document creation and testing.

🎯 What You'll Do

• Support creation, review, and approval of CSV deliverables for custom in-house solutions.
• Maintain communication with stakeholders on CSV needs and project status.
• Create documents to existing standards and respond to stakeholder reviews.
• Follow SOPs and industry best practices.

📋 Requirements

• 8–10+ years in pharmaceutical, biotechnology, or regulated manufacturing environments
• 5+ years of experience in Data Integrity/ALCOA+ principles
• 5+ years of experience with CSA principles
• 5+ years of experience with technical writing

✨ Nice to Have

• Experience with AI as an accelerator for document creation and testing
• Cross-functional experience in regulated areas (Research, QC, QA, etc.)
• Familiarity with electronic document management systems (Qumas, SharePoint)

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Phone Screen· 30 min
2. 2Technical Interview with Validation Lead· 60 min
3. 3Offer· 1 week