Automation & Controls Engineer

Position Overview

As an Automation & Controls Engineer, you will ensure reliable, compliant, and efficient operation of manufacturing and GMP utility control systems. Design, implement, maintain, and validate PLC/SCADA/DCS/BMS/EMS/MES interfaces, instrumentation, and automation solutions to support drug substance manufacturing operations, maximizing uptime, throughput, and data integrity while meeting 21 CFR Part 11, Annex 11, and GAMP 5/CSA expectations.

• Provide daily automation support for manufacturing and GMP utilities; triage alarms; troubleshoot PLCs/HMIs, instrumentation, and networked controls; resolve deviations and prevent recurrence.
• Design/configure/implement control system changes in PLC/SCADA/DCS/BMS/EMS platforms in accordance with change control, cyber, and data integrity requirements.
• Lead/support automation for new equipment/modifications: URS/FS/DS, vendor selection, FAT/SAT, and IQ/OQ/PQ with Validation/Quality.
• Own/support CSA/CSV for GxP systems: risk assessments, test plans, traceability, and reports per GAMP 5 and site SOPs; maintain validated state.
• Develop/maintain automation standards, code libraries, alarm rationalization, historian tags; backups, disaster recovery, version control, patch management.
• Integrate data flows among MES/E , 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 clean rooms, BMS/EMS, WFI, clean steam, compressed air, CIP/SIP).
• Ensure compliance and maintain audit-ready documentation (P&IDs, loop sheets, SOPs); train operators and provide on-call coverage.

• Bachelor’s degree in relevant engineering fields (PREFERRED).
• OR Associate’s degree with 7+ years of directly relevant GMP automation experience; OR High School Diploma with 9+ years.

• Minimum 5 years in pharmaceutical/biotech GMP manufacturing automation, including hands-on PLC/SCADA/HMI programming, instrumentation, and troubleshooting.
• Validation/CSA of GxP computerized systems (GAMP
  5), change control, deviations/CAPAs.
• FAT/SAT and IQ/OQ/PQ leadership.
• Familiarity with ISA-88, ISA-95, ALCOA+, and Part 11/Annex 11.
• Preferred: MES/E  integration, historians (OSIsoft PI/AVEVA), recipe management, alarm rationalization; OT cybersecurity (ISA/IEC 62443) and GMP critical utilities experience.