CQV Engineer & System Owner - GMP Validation Lead

Katalyst CRO; San Francisco (CA); Sur place; USD 120 000 - 170 000; Plein temps

Résumé du poste

Katalyst CRO is seeking CQV Engineers / System Owners to take ownership of specific process and utility systems in Bulk or Fill Finish areas on a large-scale greenfield project. You will oversee the full CQV lifecycle from design review to qualification and handover, ensuring compliance with GMP and project standards.

The role requires hands-on ownership of systems, collaboration across CQV, engineering, automation, QA, and construction teams, and active participation in design reviews and GxP

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 (preferred).
• Ability to work in a cross-functional, fast-paced project environment.
• Familiarity with KneTelecommunicationrade; (electronic CQV documentation platform) is a nice to have.

Responsabilités

• 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.

Connaissances

CQV lifecycle

System ownership

GMP familiarity

Cross-functional teamwork

Description du poste

Katalyst CRO is seeking CQV Engineers / System Owners to take ownership of specific process and utility systems in Bulk or Fill Finish areas on a large-scale greenfield project. You will oversee the full CQV lifecycle from design review to qualification and handover, ensuring compliance with GMP and project standards.

The role requires hands-on ownership of systems, collaboration across CQV, engineering, automation, QA, and construction teams, and active participation in design reviews and GxP