CQV Engineer

Katalyst CRO; Chicago (IL); Vor Ort; USD 110.000 - 165.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CQV lifecycle

System ownership

GMP experience

Tools

ASTM E2500

Jobbeschreibung

Job Description

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.