Must Haves:

• Bachelor's Degree in Engineering or related field
• 5+ years of experience in pharmaceutical or GMP or manufacturing
• Troubleshooting process control systems Delta V, mechanical aptitude.
• Commissioning experience in a startup environment
• Experience with loop tuning
• Openness to travel (U.S., Europe) for FATs - typically 1-2 week stints at a time.

Pluses:

• Master's Degree in Engineering or related field
• Stainless steel experience (SST)
• Experience with Chromatography
• Process Engineering, Chemical Engineering, or Mechanical Engineering background

Job Description:

Our client is looking for multiple Downstream CQV Engineers to join their team in Raleigh-Durham. These engineers will support drug substance manufacturing buildings and help support process equipment. Process Equipment includes, but not limited to Buffer/Media Preparation, Buffer Hold, Chromatography Skids, Chromatography Columns, Column Packing, Product Hold Arrays, Ultrafiltration/Diafiltration, Intermediate Bulk Fill, Filtration Skids, Transfer Stations, Harvest/Centrifugation, Seed and Production Bioreactors.

The engineer will collaborate with cross-functional teams to support the successful delivery of the equipment scope project, ensuring that all operational systems are safe, reliable, and meet the intended design specifications. Support generation and execution of CQV lifecycle documentation including Factory Acceptance Testing (FAT), wraparounds, Design Qualification (DQ), Requirements Trace Matrix (RTM), Quality Risk Assessment (QRA), Site Acceptance Testing (SAT), Installation Qualification, Operational Qualification, Performance Qualification, including Final Reports.

• Plan, develop, and execute commissioning, qualification, and validation 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.