Teams at United Therapeutics

Leads automation and controls engineering for distributed control, manufacturing and packaging automation, and environmental monitoring systems in a regulated pharmaceutical environment. Responsibilities include PLC, HMI, network, database, and code troubleshooting; system design and implementation; project leadership; validation and change control; maintenance; standards review; and collaboration with engineering, manufacturing, IT, and validation teams.

Supports strategic development programs involving drug formulation, device and combination products, clinical supply, CMC activities, regulatory milestones, and launch planning. Manages timelines, vendors, budgets, clinical trial materials, documentation, labeling, change controls, and cross-functional coordination across Manufacturing, Quality, Regulatory, Clinical Operations, Marketing, and supply chain teams.

Manages end-to-end product complaint handling, investigations, regulatory reporting, returned goods, and quality-system workflows for drugs, devices, biologics, and combination products. Supports vendor oversight, audits, inspections, CAPAs, risk assessment, training, regulatory compliance, and process improvements. Coordinates with QA, pharmacovigilance, patients, healthcare professionals, pharmacies, and internal and external partners to ensure accurate, timely complaint resolution and reporting.