Hardware Program Lead Job at Fusion Life Sciences Technologies LLC in West India

Job Title: Hardware Program Lead Location : Indianapolis, IN Duration : Long Term Lead and manage hardware-related projects across the lifecycle, from concept and design to deployment and validation. Define project goals, deliverables, and timelines while ensuring alignment with organizational objectives. Design and implement hardware solutions, including automation systems, robotics, and specialized equipment used in pharmaceutical manufacturing. Collaborate with equipment vendors to procure, install, and commission hardware. Ensure compatibility and integration of hardware with software systems such as MES, SCADA, and ERP platforms. Ensure all hardware complies with regulatory requirements, such as FDA cGMP, 21 CFR Part 11, and EU GMP standards. Develop and execute validation protocols (IQ, OQ, PQ) for new hardware systems. Provide technical expertise in the selection, design, and troubleshooting of manufacturing hardware. Lead the resolution of hardware-related challenges during development and production phases.