We are seeking a Commissioning and Qualification Engineer to support the installation, startup, commissioning and qualification of new single-use bioprocess equipment. The engineer will work closely with Process Engineering, Automation, CSV, Quality, equipment vendors and Operations. This position requires strong equipment and process knowledge, with the ability to translate process requirements into meaningful commissioning and qualification testing.
Senior Validation Engineer Responsibilities:
• Support design reviews and equipment-system assessments.
• Review URSs, P&IDs, process-flow diagrams, equipment specifications and vendor documentation.
• Review control narratives, functional specifications and I/O lists.
• Support equipment FAT and SAT activities.
• Perform equipment walkdowns and verify installation against approved drawings and specifications.
• Support commissioning, startup and turnover activities.
• Develop and execute commissioning, IQ and OQ documentation.
• Verify instrumentation, calibration status, utilities and equipment components.
• Support loop checks and I/O verification.
• Challenge alarms, interlocks, permissives and equipment safety functions.
• Test equipment operating sequences, recipes, phases and process transitions.
• Support pump, valve, flow, pressure, temperature, weight and mixing-function testing.
• Support PID-loop verification and process stabilization.
• Coordinate punch-list resolution and system turnover.
• Document discrepancies and support investigation and resolution.
• Support engineering runs, water runs, buffer runs and initial process execution.
• Provide process and equipment SME support during CSV testing.
• Support SOPs, operating instructions, maintenance procedures and training.
Job Requirements:
• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering or a related discipline.
• Approximately five or more years of equipment commissioning, qualification, process engineering or validation experience in biotechnology or pharmaceutical manufacturing.
• Experience with bioprocess equipment such as TFF skids, bioreactors, chromatography systems or single-use processing equipment.
• Experience executing FAT, SAT, commissioning, IQ or OQ activities.
• Ability to read P&IDs, functional specifications, control narratives and I/O documentation.
• Experience testing alarms, interlocks, permissives and automated operating sequences.
• Strong field-execution, troubleshooting and technical-writing skills.
• Ability to work directly with vendors, Operations, Engineering and Quality.
• Experience with KrosFlo, ÄKTA chromatography and UNICORN preferred.
• Experience with single-use bioreactors.
• Exposure to KlariFi, Lucullus or DeltaV.
• Experience with PID-controlled process systems.
• Experience supporting equipment startup within a new or renovated GMP facility.
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