System Owner

Role Summary

We are looking for CQV Engineers / System Owners to take ownership of specific process and utility systems within either the Bulk (Drug Substance) or Fill Finish (Drug Product) areas on a large-scale greenfield project.

This role focuses on system ownership across the full CQV lifecycle, from design review through to qualification and handover, ensuring all systems are delivered in line with GMP and project standards.

Key Responsibilities

• Act as System Owner for assigned equipment within Bulk or Fill Finish areas
• Participate in design reviews and ensure alignment with URS and GMP requirements
• Lead and/or support development of GxP documentation (URS, SRA, DQ, RTM, protocols)
• Support commissioning and qualification activities (FAT, SAT, IQ/OQ/PQ where applicable)
• Manage and track system deliverables in line with project schedule
• Coordinate...