GMP Automation Commissioning Lead

Alliance Biotech Solutions; Sanford (NC); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Flexible PTO (20 days)

Disability insurance (LT/ST)

Job summary

Alliance Biotech Solutions seeks an Automation Commissioning Engineer to lead commissioning, startup, troubleshooting, and turnover of GMP automation systems in pharmaceutical manufacturing.

The role acts as the technical lead for commissioning activities, coordinating with integrators, vendors, engineering, validation, quality, IT/OT, and equipment suppliers to ensure systems are safely commissioned and ready for qualification and manufacturing.

Qualifications

• 5+ years in automation commissioning in pharma/biotech.
• Experience with GMP manufacturing equipment and automation systems.
• Proficient reading P&IDs and electrical drawings.
• Familiar with cGMP, FDA regulations, ISPE, and GAMP 5.

Responsibilities

• Lead commissioning, startup, troubleshooting, and turnover of GMP automation systems.
• Serve as technical lead for automation commissioning activities with multiple teams.
• Drive the commissioning plan and resolve field issues.
• Coordinate daily commissioning activities with integrators, vendors, construction, validation, quality, IT/OT, and manufacturing.
• Verify installation and operation of PLCs, DCS, SCADA/HMI, I/O, and network infrastructure.
• Develop and maintain commissioning documentation, turnover packages, punch lists, and logs.
• Support FAT, SAT, system turnover, and transition to qualification and manufacturing.

Skills

Automation engineering

CQV/CGMP

P&ID Reading

PLC/SCADA/DCS

Electrical drawings

GAMP 5 familiarity

Project coordination

Education

Bachelor's degree in engineering

Tools

PLC/SCADA software

DCS/HMI platforms

Job description

Alliance Biotech Solutions seeks an Automation Commissioning Engineer to lead commissioning, startup, troubleshooting, and turnover of GMP automation systems in pharmaceutical manufacturing.

The role acts as the technical lead for commissioning activities, coordinating with integrators, vendors, engineering, validation, quality, IT/OT, and equipment suppliers to ensure systems are safely commissioned and ready for qualification and manufacturing.