CQV Automation Lead

• Bachelor's Degree in Engineering, Automation Engineering, Electrical Engineering, Chemical Engineering, or a related technical field.
• 5+ years of experience supporting CQV, Automation, Commissioning, Validation, or Startup activities within pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Strong hands‑on experience with Distributed Control Systems (DCS) commissioning and startup activities.
• Experience supporting automation platforms such as: DCS, PLCs, MES, SCADA/HMI Systems
• Strong understanding of commissioning and qualification lifecycle activities including FAT, SAT, IQ, OQ, and system turnover.
• Experience working within GMP-regulated pharmaceutical manufacturing facilities.
• Ability to work effectively in cross-functional project environments and support field execution activities.

• Experience with Ignition SCADA software.
• Experience supporting large capital projects and facility startup efforts.
• Previous leadership experience on CQV or automation projects.
• Greenfield pharmaceutical manufacturing project experience.
• Familiarity with Emerson DeltaV, Rockwell, Siemens, or other major automation platforms.

We are seeking a CQV Automation Lead to support a large-scale pharmaceutical manufacturing commissioning and startup project in Sanford, NC. This individual will serve as a key automation SME, overseeing commissioning, qualification, and validation activities for critical automation systems throughout the facility. The ideal candidate will possess strong experience with Distributed Control Systems (DCS) and automation commissioning within pharmaceutical or other GMP-regulated environments.

This role will work closely with Engineering, CQV, Automation, Operations, Quality, and Construction teams to ensure automation systems are successfully commissioned, verified, and transitioned into operation.

• Lead commissioning, qualification, and startup activities for automation systems supporting pharmaceutical manufacturing operations.
• Serve as the primary automation SME for DCS-related commissioning activities.
• Support commissioning and verification of automation platforms including DCS, PLC, MES, SCADA, and integrated control systems.
• Coordinate and execute automation testing activities including FATs, SATs, loop checks, functional testing, and startup support.
• Review automation design documentation, control narratives, functional specifications, and system architecture drawings.
• Collaborate with Automation, CQV, Engineering, Manufacturing, and Quality teams to resolve technical issues and drive project deliverables to completion.
• Support development and execution of commissioning and qualification documentation.
• Participate in system walkdowns, punch list management, and turnover activities.
• Troubleshoot automation system issues during commissioning and startup phases.
• Ensure all activities are performed in accordance with cGMP, FDA, and project compliance requirements.
• Provide technical guidance and leadership to project teams during execution.