Tracy Hart

Tracy Hart is an Engineering Manager – Pharmaceutical Projects at Siemens Digital Industries, with over 20 years of experience delivering and governing automation, MES, and digital manufacturing solutions in highly regulated pharmaceutical environments. Tracy leads pharmaceutical engineering and solution teams responsible for the design, delivery, and qualification of GxP compliant automation and MES systems, with a strong focus on GAMP 5, 21 CFR Part 11, and Annex 11 compliance. Her role spans execution strategy, governance frameworks, validation approaches, and the establishment of standardized engineering and quality practices. Having held leadership roles across both the UK and US, Tracy brings deep, hands on experience bridging operational reality and compliance expectations—ensuring that digital innovation is introduced in a way that is auditable, secure, and trusted by quality, IT, and operations stakeholders alike. Tracy brings a practitioner’s perspective on Industrial AI, grounded in real world execution, focused on how AI can be activated safely within validated architectures, with governance, auditability, and human oversight designed in from the start.