LOTTE BIOLOGICS Benefits Overview

Supports automation systems in a biopharmaceutical manufacturing facility, including process and building controls, S88 batch systems, hardware, device integration, networking, configuration, testing, troubleshooting, and 24/7 operational support. Collaborates with manufacturing, engineering, quality, validation, facilities, and IT teams while ensuring cGMP, EHS, documentation, and regulatory compliance. The role also contributes to automation projects, root-cause investigations, system implementations, and continuous improvement initiatives.

Serves as the technical SME for ADC manufacturing across clinical and commercial programs, leading conjugation, purification, formulation, scale-up, technology transfer, process validation, and continuous improvement. Supports floor operations, deviation investigations, root cause analysis, CAPA, audits, regulatory responses, documentation, risk assessments, and cGMP compliance. Collaborates cross-functionally with manufacturing, quality, automation, HSE, facilities, supply chain, and process development teams while mentoring junior engineers. The role requires work in cleanrooms and around hazardous, highly potent compounds.

Leads process engineering ownership for mAb and ADC programs across facility fit, technology transfer, scale-up, PPQ, commercial manufacturing, and lifecycle improvement. Evaluates equipment, utilities, containment, automation, capacity, and GMP requirements; directs risk assessments, investigations, CAPAs, validation, and capital project support. Partners with cross-functional and client teams, authors technical documentation, provides on-floor leadership, and mentors engineers.