CQV System Owner – GMP Full Lifecycle Lead

Katalyst CRO

Chicago (IL)

On-site

USD 110,000 - 165,000

Full time

8 days ago

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Job summary

Katalyst CRO seeks CQV Engineers / System Owners to own specific process and utility systems on a large-scale greenfield project in the Chicago area. You will manage the full CQV lifecycle from design review through qualification and handover, ensuring GMP alignment and project standards.

Responsibilities include leading design reviews, developing URS/SRA/DQ/RTM protocols, and supporting FAT/SAT/IQ/OQ/PQ activities while coordinating with CQV, Engineering, QA, Automation, and Construction teams

Qualifications

Extensive CQV/Process Engineering experience in GMP environments.
Hands-on system ownership and equipment qualification experience.
Experience with large CAPEX or GMP manufacturing projects.
Familiarity with ASTM E2500 / risk-based qualification approaches.

Responsibilities

Act as System Owner for assigned equipment in 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 with CQV, Engineering, Automation, QA, and Construction teams.
Identify and manage risks, issues, and dependencies related to assigned systems.
Support verification planning aligned to ASTM E2500 methodology.
Ensure systems are ready for handover to validation/operations.