Automation Engineer I, II & III

United Pharma; North Carolina; On-site; USD 75,000 - 110,000; Full time

Job summary

United Pharma is seeking an automation engineer to design and implement automation architectures across DCS, PLC/SCADA, MES, historians, and field instrumentation for validated manufacturing facilities.

You will lead documentation, validation activities, and cross-functional collaboration to meet GMP and data-integrity requirements while supporting 24/7 operations and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Automation, or related field.
• 2+ years hands-on experience in MES platforms or PLC/DCS systems (DeltaV or Rockwell).
• Experience with BMS/EMS platforms and pharmaceutical environments.
• Familiarity with GMP, GAMP 5, 21 CFR Part 11, validation, and automation lifecycle.

Responsibilities

• Design and develop automation architectures across DCS, PLC/SCADA, MES, historians, and field instrumentation for biologics, pharmaceutical, and novel therapy manufacturing facilities.
• Lead URS/FRS & Design Documentation creation and ensure documentation traceability.
• Configure, program, test, and deploy DCS and PLC systems; support FAT, SAT, IQ, OQ, PQ activities per GAMP 5 and 21 CFR Part 11.

Skills

DCS/PLC/SCADA

GMP/21 CFR Part 11

ISA-88 Knowledge

Troubleshooting

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

DeltaV

Rockwell

MES platforms

BMS/EMS

Job description

• Design and develop automation architectures across DCS, PLC/SCADA, MES, historians, and field instrumentation for biologics, pharmaceutical, and novel therapy manufacturing facilities.
• Ensure automation solutions align with project requirements, industry standards, and GMP expectations.

URS/FRS & Design Documentation

• Lead the preparation, review, and approval of URS, FRS, DS/DDS, Functional Specifications, Control Narratives, and ISA-88-compliant recipe documentation.
• Ensure design documentation is accurate, traceable, and aligned with process and user requirements.

Automation Implementation

• Configure, program, test, and deploy DCS and PLC systems.
• Support the integration of OEM skids, HVAC systems, chillers, boilers, and other facility/process equipment.
• Execute and support FAT, SAT, IQ, OQ, and PQ activities in accordance with GAMP 5 and 21 CFR Part 11 requirements.
• Lead deviation investigations, root-cause analysis, and CAPA activities related to automation and control systems.
• Ensure automation systems remain compliant with applicable GMP and data-integrity requirements.

Manufacturing & Operations Support

• Serve as a subject matter expert for automation systems, providing troubleshooting and technical support for manufacturing operations.
• Perform alarm analysis and tuning and support 24/7 resolution of critical operational issues.

Cross-Functional Leadership

• Collaborate with IT/OT, process engineering, quality, manufacturing, and capital project teams to deliver automation solutions.
• Coordinate with vendors and system integrators throughout project execution and commissioning.
• Mentor and provide technical guidance to junior automation engineers.

Ideal Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Automation, or a related discipline.
• 2+ years of hands‑on experience in at least one of the following areas:
• MES platforms
• PLC/DCS systems, including DeltaV or Rockwell
• BMS/EMS platforms
• Experience in pharmaceutical, biologics, cell/gene therapy, or other regulated manufacturing environments is highly desirable.
• Familiarity with GMP, GAMP 5, 21 CFR Part 11, validation, and automation lifecycle practices is preferred.