Our client in the Raleigh-Durham area is looking for a CQV Installation Verification Engineer to join their team in Raleigh-Durham. The engineer will support drug substance manufacturing buildings and help support installation verification and CQV activities for upstream, downstream, and utilities equipment. Equipment includes, but not limited to buffer/media preparation, buffer hold, chromatography skids and columns column packing, ultrafiltration/diafiltration, filtration skids, transfer stations, harvest/centrifugation, seed and production bioreactors, SIP/CIP.
Plan, develop, and execute CQV and IV protocols
Develop protocols, reports, and validation plans in the Kneat electronic validation system to support project milestones.
Support CQV from design phase, acceptance testing, startup, qualification, to final handover to operations.
Liaise with EPCM contractor in relation to construction readiness and schedule for Process Equipment Systems
Perform and support field walkdowns for systems.
Support CQV review, aligning with Turnover Group in relation to review and approval of Vendor and Contractor Turnover Packages within scope.
Support punchlist closure and verification pre-Mechanical Completion and during the CQV execution phase for Process Equipment systems.
Liaise with CQV Project Management and Scheduling in relation to schedule creation and management for all Process Equipment, ensuring all correct predecessors and successors are in place.
Ensure Commissioning readiness of all Process Equipment Systems to support Equipment Start-up and IOQ Testing.
Support Pre-Startup Safety Review and Set to Work field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.
Support CQV Process with engineering documentation management system and ensure full traceability at all times for all systems.
Liaise with all Project Groups (Design/Construction Management /CQV/Automation/Process/SMEs/Operations/Maintenance/Project Management/Quality) to ensure all Process Equipment systems are managed appropriately for the entire Project Lifecycle.
Liaise with CQV Document Generation Support in relation to generation and approval of; DQ/Design Reviews /Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ Protocols
Run Weekly CQV Process Equipment to ensure status updates are provided to cross-functional team.
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Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.