Senior Bioprocess CQV Engineer

Verista; Massachusetts, United States, Northern America, Americas; Híbrido; USD 80.000 - 123.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

Life Insurance

Short-Term Disability Insurance

Long-Term Disability Insurance

Health Savings Account

Paid Time Off

Tuition Reimbursement

Team Social Activities

Descripción de la vacante

Verista seeks a Commissioning and Qualification Engineer to support installation, startup, commissioning, and qualification of single-use bioprocess equipment. The role collaborates with Process Engineering, Automation, CSV, Quality, and vendors, translating process requirements into testing plans.

You will review URSs, P&IDs, and vendor docs; participate in FAT/SAT; perform walkdowns; develop IQ/OQ documentation, and verify instrumentation and control systems.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Bioprocess equipment experience

FAT/SAT/IQ/OQ experience

Process validation

Technical writing

Vendor coordination

Educación

Bachelor's degree in Chemical/Mechanical/Biochemical Engineering

Herramientas

KrosFlo

ÄKTA chromatography

UNICORN

Single-use bioreactors

Descripción del empleo

Verista seeks a Commissioning and Qualification Engineer to support installation, startup, commissioning, and qualification of single-use bioprocess equipment. The role collaborates with Process Engineering, Automation, CSV, Quality, and vendors, translating process requirements into testing plans.

You will review URSs, P&IDs, and vendor docs; participate in FAT/SAT; perform walkdowns; develop IQ/OQ documentation, and verify instrumentation and control systems.