Automation Commissioning Engineer

ALLIANCE BIOTECH SOLUTIONS LLCSanford, NC
Onsite

About The Position

The Automation Commissioning Engineer is responsible for leading the commissioning, startup, troubleshooting, and turnover of GMP automation systems supporting pharmaceutical manufacturing operations. This role serves as the technical lead for automation commissioning activities, working closely with system integrators, engineering, validation, quality, IT/OT, and equipment vendors to ensure automation systems are safely commissioned, fully functional, and ready for qualification and manufacturing. The successful candidate will drive execution of the commissioning plan, resolve field issues, and support the transition from construction through operational readiness.

Requirements

  • 5+ years of automation, commissioning, CQV, or controls engineering experience in pharmaceutical, biotechnology, or life sciences manufacturing.
  • Experience commissioning GMP manufacturing equipment and automation systems.
  • Strong knowledge of PLCs, DCS, SCADA, HMI, and industrial automation platforms.
  • Experience performing loop checks, I/O verification, functional testing, and startup activities.
  • Ability to read and interpret P&IDs, electrical drawings, control narratives, instrument datasheets, and network diagrams.
  • Familiarity with cGMP, FDA regulations, ISPE guidance, and GAMP 5 principles.

Responsibilities

  • Lead commissioning and startup activities for Process Control Systems (PCS), Environmental Monitoring Systems (EMS), and Manufacturing Execution Systems (MES).
  • Execute loop checks, I/O verification, functional testing, alarm testing, interlock verification, and integrated system testing.
  • Coordinate daily commissioning activities with automation integrators, vendors, construction, validation, quality, manufacturing, and IT/OT teams.
  • Troubleshoot automation hardware, software, communications, and system integration issues during startup and commissioning.
  • Verify installation and operation of PLCs, DCS, SCADA/HMI systems, field instrumentation, control panels, and network infrastructure.
  • Develop and maintain commissioning documentation, turnover packages, punch lists, commissioning reports, and issue logs.
  • Support FAT, SAT, system turnover, and the successful transition into qualification and manufacturing operations.

Benefits

  • Industry competitive wage as a full-time employee
  • 20 days Flexible Paid Time Off
  • Medical, Dental and Vision Insurance with low employee cost
  • Employer paid long term and short-term disability
  • 401k plan with employer contributions
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