Process Engineer

Role SummaryWe 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 ResponsibilitiesAct as System Owner for assigned equipment within Bulk or Fill Finish areasParticipate in design reviews and ensure alignment with URS and GMP requirementsLead 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 scheduleCoordinate with CQV, Engineering, Automation, QA, and Construction teamsIdentify and manage risks, issues, and dependencies related to assigned systemsSupport verification planning aligned to ASTM E2500 methodologyEnsure systems are ready for handover to validation/operationsRequirementsHands-on experience with system ownership and equipment qualificationStrong understanding of CQV lifecycle and GxP documentationExperience working on large CAPEX or GMP manufacturing projectsFamiliarity with ASTM E2500 / risk-based qualification approaches (preferred)Ability to work in a cross-functional, fast-paced project environmentFamiliarity with Kneat™ (electronic CQV documentation platform) is a nice to have