Future-state factory design: Lead Factory of the Future elements of conceptual and basic design of new factories and major expansions, integrating process, facility, automation, material and personnel flow, and digital architecture across biologics/biotech, aseptic and sterile manufacturing, packaging and device assembly, and chemical production. Compliance and quality: Ensure designs meet cGMP, FDA/EMA Annex 1 and Annex 11/Part 11, data integrity, medical device (e.g., 21 CFR 820/ISO 13485), and EHS requirements; support commissioning, qualification, and validation strategies using risk-based approaches (CSA, ASTM E2500).