GxP Automation & Controls Engineer

Scorpion Therapeutics; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking an Automation & Controls Engineer to ensure reliable, compliant operation of manufacturing and GMP utility control systems. You will design, implement, validate, and maintain PLC/SCADA/DCS/BMS/EMS/MES interfaces to maximize uptime, data integrity, and throughput.

You will lead ISA/GxP-compliant change control, participate in FAT/SAT, support CSA/CSV, and develop automation standards while integrating data across MES, LIMS, and enterprise systems.

Qualifications

• Minimum 5 years in pharmaceutical/biotech GMP manufacturing automation, including hands-on PLC/SCADA/HMI programming, instrumentation, and troubleshooting.
• Experience with validation/CSA of GxP computerized systems (GAMP 5), change control, deviations/CAPAs.

Responsibilities

• Provide daily automation support for manufacturing and GMP utilities; triage alarms and troubleshoot PLCs/HMIs, instrumentation, and networked controls.
• Design/configure/implement control system changes in PLC/SCADA/DCS/BMS/EMS platforms per change control and data integrity requirements.
• Lead automation for new equipment/modifications: URS/FS/DS, vendor selection, FAT/SAT, and IQ/OQ/PQ with Validation/Quality.
• Own CSA/CSV for GxP systems: risk assessments, test plans, traceability, and reports per GAMP 5 and site SOPs.
• Develop/maintain automation standards, code libraries, alarm rationalization, historian tags; backups, disaster recovery, version control, patch management.
• Integrate data flows among MES/EBR, LIMS, historians, and enterprise systems to ensure ALCOA+ integrity and timely release; build dashboards.
• Translate process requirements into control strategies/instrumentation/interlocks/recipes.
• Support root cause analysis and author CAPAs/effectiveness checks; implement error-proofing and alarm management improvements.
• Oversee automation for critical utilities/facilities (HVAC cleanrooms, BMS/EMS, WFI, clean steam, CIP/SIP).
• Ensure compliance and maintain audit-ready documentation (P&IDs, loop sheets, SOPs); train operators and provide on-call coverage.

Skills

PLC/SCADA/HMI programming

Instrumentation

Troubleshooting

Change control

Data integrity

Alarm management

Root cause analysis

CAPA

GxP/compliance

OT cybersecurity

Education

Bachelor’s degree in relevant engineering fields

Associate’s degree + 7+ years GMP automation

High School Diploma + 9+ years GMP automation

Tools

OSIsoft PI/AVEVA

Job description

Scorpion Therapeutics is seeking an Automation & Controls Engineer to ensure reliable, compliant operation of manufacturing and GMP utility control systems. You will design, implement, validate, and maintain PLC/SCADA/DCS/BMS/EMS/MES interfaces to maximize uptime, data integrity, and throughput.

You will lead ISA/GxP-compliant change control, participate in FAT/SAT, support CSA/CSV, and develop automation standards while integrating data across MES, LIMS, and enterprise systems.