Automation & Controls Engineer

Role: Automation & Controls Engineer responsible for ensuring reliable, compliant operation of manufacturing automation systems supporting GMP drug substance production at a Raleigh, NC site. Responsibilities include troubleshooting alarms, designing control system modifications, leading validation efforts, and maintaining data integrity across PLC/SCADA, DCS, BMS, EMS, MES interfaces. The role involves supporting new equipment integration, system validation (GAMP 5/CSA), and ensuring cybersecurity and regulatory compliance (21 CFR Part 11, Annex 11). Collaboration spans Manufacturing, Quality, Validation, Utilities, and Supply Chain teams, with a focus on process data integrity, environmental control utilities, and audit readiness. Requirements: Bachelor’s in engineering or related field preferred; 5+ years of GMP automation experience in pharmaceutical or biotech manufacturing, with hands-on PLC/SCADA/HMI programming, validation, and troubleshooting skills. Experience with FAT/SAT, IQ/OQ/PQ, and knowledge of batch control, system integration, and data integrity standards necessary. Additional preferred skills include MES/EBR systems, historian platforms, alarm management, and cybersecurity (ISA/IEC 62443). Work setup: onsite in Raleigh, NC; no visa sponsorship. The role demands strong technical expertise, regulatory compliance experience, and cross-functional collaboration within a GMP manufacturing environment.