Senior Engineer II/III, Automation and MES

Role: Senior Automation Engineer supporting GMP manufacturing at a multi-modality biopharma site, focusing on Rockwell PharmaSuite MES and automation systems. Responsibilities include configuring, validating, and maintaining MES and automation systems, developing electronic batch records, managing change control, and supporting system lifecycle and integrations with SAP, LIMS, and PI. The role involves supporting inspection readiness, troubleshooting GMP automation issues, and contributing to long-term automation strategy development. Requirements: BS in Engineering or related field; 6+ years for Engineer II, 8+ years for Sr. Engineer III with proven GMP automation/MES experience; hands-on expertise with Rockwell PharmaSuite or similar platforms; experience in regulated pharma/biotech environments including validation, data integrity, and electronic batch records. High-value: GMP manufacturing, cell/gene therapy modalities, support for BLA filings, pre-license inspection, and commercial scale-up; interface with manufacturing operations, quality, validation, and IT teams. Work setup involves on-site support at Durham/RTP, NC, with participation in an on-call support rotation.