Summary:

The Lead Validation Engineer leads GMP equipment installation, commissioning, and qualification projects supporting large-molecule biologics manufacturing. This role supports upstream and downstream processes and ensures projects are executed safely, on schedule, and in compliance with regulatory and quality requirements.

Roles & Responsibilities:

• Lead end-to-end CQV execution for GMP equipment projects, managing activities from installation through IQ, OQ, and PQ for biologics manufacturing systems including bioreactors, media/buffer preparation, chromatography, filtration, and associated utilities


• Drive project planning and execution, developing and maintaining integrated schedules, budgets, and resource plans while proactively identifying risks and implementing mitigation strategies to support on-time, compliant delivery


• Coord...