Hardware Program Lead at Fusion Life Sciences Technologies LLC

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.