Senior CQV Engineer

We are seeking a Senior CQV / Validation Engineer to support the installation, startup, commissioning, and qualification of new single-use bioprocess equipment in a GMP manufacturing environment. The engineer will work closely with Process Engineering, Automation, CSV, Quality, Operations, and equipment vendors.

Responsibilities

• Support equipment design reviews and system assessments.
• Review URS, P&IDs, process-flow diagrams, equipment specifications, control narratives, functional specifications, and I/O lists.
• Support and execute FAT, SAT, commissioning, IQ, and OQ activities.
• Perform equipment walkdowns and verify installation against approved drawings and specifications.
• Verify instrumentation, calibration, utilities, and equipment components.
• Perform loop checks and I/O verification.
• Test alarms, interlocks, permissives, safety functions, operating sequences, recipes, and process transitions.
• Support testing of pumps, valves, flow, pressure, temperature, weight, mixing, and PID-controlled systems.
• Manage punch-list items, discrepancies, investigations, and system turnover.
• Support engineering runs, water/buffer runs, SOP development, training, and initial process execution.
• Provide equipment/process SME support during CSV activities.

Requirements

• Bachelor’s degree in Chemical, Mechanical, Biochemical Engineering, or related field.
• 5+ years of commissioning, qualification, process engineering, or validation experience in biotechnology or pharmaceutical manufacturing.
• Hands-on experience with bioprocess equipment, including TFF skids, bioreactors, chromatography systems, or single-use processing equipment.
• Experience with FAT, SAT, commissioning, IQ, and OQ.
• Strong ability to read P&IDs, control narratives, functional specifications, and I/O documentation.
• Experience testing alarms, interlocks, permissives, and automated equipment sequences.
• Strong field execution, troubleshooting, documentation, and technical-writing skills.
• Ability to work directly with Vendors, Operations, Engineering, and Quality teams.
• Experience supporting equipment startup in a new or renovated GMP facility.

Location: Devens, MA
Duration: Contract