Director, Automation
Core
Develop and execute automation, digital systems, and operational technology (OT) strategy for small molecule drug substance manufacturing projects.
Role type
Director, Automation Lead
Builds
Automation systems, digital manufacturing roadmaps, and control architectures for GMP manufacturing facilities.
Domain
Pharmaceutical manufacturing / Operational Technology (OT)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Automation strategy definition, system integration, GMP compliance, vendor management, cross-functional leadership, risk mitigation, lifecycle management, regulatory knowledge (GAMP 5, CSV, data integrity), cybersecurity standards, batch process control, stakeholder influence.
Preferred skills
Multi-product API manufacturing experience, CDMO environment experience, integration of DCS/PLC/MES/historians, ISA-88/ISA-95/ISA/IEC 62443 frameworks.
Technologies
MES, SCADA, DCS, PLC, Historians, ISA-88, ISA-95, ISA/IEC 62443
Responsibilities
Lead automation workstreams for growth investment projects, define automation architecture and digital roadmap, partner with Engineering/Quality/IT teams on design, manage commissioning/qualification/start-up activities, manage vendors and partners, ensure regulatory and cybersecurity compliance, establish long-term support models.
Seniority
Director, strategic leadership & execution
