Business Process Specialist - Logistics Process & Compliance (CVRM)

About the role

Roche/Genentech is building a $2 billion greenfield drug product manufacturing plant in Holly Springs, North Carolina, focused on cardiovascular, renal and metabolism medicines. As Business Process Specialist you will ensure that end-to-end intralogistics processes, material flows and automated warehousing comply with cGMP regulations, Health Authority expectations and Roche Global Quality Standards. You will work in a paperless, highly automated environment and bridge logistics engineering, warehouse operations, quality assurance and digital systems.

Key responsibilities

• Act as business process expert for SAP S/4HANA (EWM), ASRS, AGVs, AMRs, WCS and other automated warehouse systems
• Define site-level intralogistics processes, material routing and PFEP/PFEF plans for raw materials, components, consumables and cold-chain WIP
• Author and review SOPs, validation protocols and commissioning documentation for automated logistics and temperature-controlled storage (+2 to +8C, -20C and ambient)
• Support setup, testing and commissioning of material handling equipment, downflow booths and automated pallet conversion systems
• Serve as SME for FDA/EMA audits on warehousing, material handling, cold-chain integrity and distribution
• Lead root-cause investigations of logistics deviations and temperature excursions, and run CAPAs using Lean Six Sigma
• Monitor intralogistics KPIs, optimize dock-to-stock and kitting cycle times, and manage logistics change controls and SAP EWM master data
• Help develop a data visualization strategy for real-time logistics management

Required profile

• Bachelor's degree in Industrial Engineering, Supply Chain Management, Logistics, Operations or a related scientific/technical discipline
• Minimum 6+ years (SE5) or 8+ years (SE6) of progressive experience in logistics, intralogistics engineering or materials management in cGMP environments (pharmaceutical, biotech or medical device required)
• Proven experience in greenfield startup operational readiness and qualification of automated systems
• Experience leading root-cause investigations, CAPA development, FMEA/risk assessments and Lean Six Sigma projects
• Standard day shift (Monday-Friday); up to 25% travel during pre-launch and commissioning, then about 10%
• No relocation assistance available

Required skills

• Deep technical expertise in SAP S/4HANA and Extended Warehouse Management (EWM)
• Hands-on experience with ASRS, AGVs, AMRs, WCS and high-speed material conveyance
• Knowledge of cGMP, GDP, 21 CFR Part 11/Annex 11 and Annex 1 cold-chain requirements

Expected salary range for Holly Springs: $98,600 - $183,000, depending on experience and qualifications; a discretionary annual bonus may be available.