Senior Validation Engineer

Job Summary

Leading validation activities in a full-time capacity, the Senior Validation Engineer will develop, execute, and manage validation lifecycle documentation for equipment and processes in GMP regulated environments while serving as a subject matter expert and providing guidance to junior team members.

Key Responsibilities

• Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for GMP regulated assets
• Oversee validation activities for internal and client tech transfer projects, including authoring and executing validation documents
• Provide technical mentorship and guidance to junior validation staff while collaborating cross-functionally to align validation activities with project timelines

Required Qualifications

• Bachelor's degree in a life science, engineering, or related technical field
• 7-11 years of experience in the biotech, pharmaceutical, or medical device industry
• Strong knowledge of FDA cGMP requirements and risk-based validation principles
• Advanced validation expertise in equipment, computerized systems, and process validation
• Experience supporting audits and regulatory inspections