Job Details

🚀 We're Hiring | Senior Validation Engineer (Contract Role)

📌 Job Title: SD Senior Validation Engineer

📍 Location: San Francisco, CA 94080

🕒 Duration: 6 Months Contract

🔬 About the Role

We are seeking an experienced Senior Validation Engineer with a strong background in validation within a regulated pharmaceutical environment. The ideal candidate will have hands-on experience in equipment qualification, thermal mapping, and computer system validation while ensuring compliance with industry regulations and quality standards.

✅ Core Responsibilities & Requirements

⚙️ Equipment Qualification

• Perform full lifecycle IQ/OQ/PQ activities
• Conduct periodic reviews to maintain compliance

🌡️ Thermal Mapping

• Experience with temperature mapping preferred
• Exposure to warehouses, cold chain environments, and autoclaves

💻 Computer System Validation (CSV)

• Strong understanding of GAMP 5, 21 CFR Part 11, and Annex 11
• Ensure compliance of computerized systems in regulated environments

📝 Documentation

• Author and execute validation protocols
• Prepare complex validation summary reports with minimal supervision

🎯 Required Experience

✔️ 7–10 years of experience in a pharmaceutical, biotech, or regulated life sciences environment

✔️ Strong validation and compliance background