Principal/Senior Principal Engineer, Packaging (Holly Springs)
Core
Oversee the design, qualification, and operational startup of a greenfield packaging area for a state-of-the-art Drug Product Fill and Finish facility, transitioning to ongoing optimization and compliance management.
Role type
Principal/Senior Principal Manufacturing Engineer (Packaging)
Builds
High-volume, highly-efficient Drug Product manufacturing lines (labeling, cartoning, case packing, palletizing) for Cardiovascular, Renal, and Metabolism medicines.
Domain
Pharmaceutical manufacturing / Packaging engineering / Smart factory
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical packaging operations expertise, process validation, regulatory submissions, equipment qualification, data analytics, project management, operator training, change management
Preferred skills
Master's or Ph.D. degree, advanced problem-solving in unprecedented scenarios, senior-level stakeholder influence, coaching and mentoring, deep knowledge of cGMPs and Health Authority regulations
Technologies
Robotics, digital tools, real-time data analytics, automated inspection systems, autoinjector/pen assembly equipment
Responsibilities
Implement fit-for-purpose labeling and secondary packaging technology; ensure optimum equipment selection and qualification for high output efficiency; select, train, and mentor operators and maintenance technicians; drive continuous improvement to improve quality, yield, and OEE; monitor machine performance and trend data to predict issues; manage New Product Introductions; maintain equipment knowledge library and change management.
Seniority
Principal/Senior Principal, hands-on IC with strategic oversight