CQV Engineer

Katalyst CRO; Chicago (IL); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO is seeking CQV Engineers/System Owners in Chicago, Illinois, to manage specific process and utility systems within Bulk or Fill Finish areas. This role emphasizes system ownership across the entire CQV lifecycle.

The ideal candidate will have extensive experience in CQV/Process Engineering in GMP settings, ensuring compliance with project standards. Responsibilities include managing GxP documentation, supporting commissioning and qualification activities, and ensuring seamless handover to operations.

Qualifications

• 47 years' experience within CQV / Process Engineering in GMP environments.
• Hands-on experience with system ownership and equipment qualification.
• Strong understanding of CQV lifecycle and GxP documentation.
• Experience working on large CAPEX or GMP manufacturing projects.
• Familiarity with ASTM E2500 / risk-based qualification approaches.

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.
• Support commissioning and qualification activities.
• Manage and track system deliverables in line with project schedule.

Skills

CQV / Process Engineering experience

System ownership

GMP documentation

Cross-functional collaboration

Job description

Overview

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.

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 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.

Requirements

• 47 years' experience within CQV / Process Engineering in GMP environments.
• Hands-on experience with system ownership and equipment qualification.
• Strong understanding of CQV lifecycle and GxP documentation.
• Experience working on large CAPEX or GMP manufacturing projects.
• Familiarity with ASTM E2500 / risk-based qualification approaches (preferred).
• Ability to work in a cross-functional, fast-paced project environment.
• Familiarity with KneTelecommunicationrade; (electronic CQV documentation platform) is a nice to have.