Senior Technical Lead

Job Summary

To support infrastructure-related applications, the full-time Senior Technical Lead will validate and implement systems in the pharmaceutical, biotechnology, or medical device industry while collaborating with remote teams and managing multiple projects.

Key Responsibilities

• Validate and implement infrastructure systems associated with applications in regulated environments
• Write and execute documentation for validation deliverables, including compliance plans and test protocols
• Provide validation guidance and timely reviews, ensuring adherence to FDA guidelines and GxP standards

Required Qualifications

• 3+ years of experience in Computer System Validation within FDA-regulated environments
• 2+ years of experience with the System Development Lifecycle
• Hands-on experience in the pharmaceutical, biotechnology, or medical device industry
• Knowledge of FDA guidance and industry standards, including GAMP
• Experience in QA methodologies and reviewing test plans and user acceptance test scripts