Automation Commissioning Engineer

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

Description

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

• 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.

Experience/Skills

• 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.

Benefits & Compensation

• 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

About Alliance Biotech Solutions

Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success.

Alliance Biotech Solutions is an Equal Employment Opportunity / Affir­mative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee.

All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.