The Opportunity
You will serve as a pioneering force during our pre-startup build-out and post-launch operations. You are responsible for ensuring that our end-to-end intralogistics processes, material flows, and automated warehousing infrastructure comply strictly with cGMP regulations, Health Authority expectations, and Roche Global Quality Standards. Working in a paperless, highly automated environment, you will bridge the gap between logistics engineering, warehouse operations, quality assurance, and digital technology systems.
What You'll Do
- Operational Readiness & System Build-Out: Act as the business process expert for SAP S/4HANA (EWM), Automated Storage and Retrieval Systems (ASRS), Automated Guided Vehicles (AGVs), Autonomous Mobile Robots (AMRs), and Warehouse Control Systems (WCS).
- Material Flow & Process Optimization: Partner with cross-functional engineering, robotics, and operations teams to define site-level intralogistics processes, material routing, and a Plan for Every Part (PFEP) and Plan for Every Flow (PFEF) for direct raw materials, components, consumables, and cold-chain Work-In-Progress (WIP).
- Quality & Compliance Architecture: Author and review logistics Standard Operating Procedures (SOPs), validation protocols, and commissioning documentation for automated logistics systems and temperature-controlled storage (+2 to +86C, -206C, and ambient).
- Equipment Qualification Support: Collaborate with automation vendors and Engineering to support set-up, testing, and commissioning activities for material handling equipment, downflow booths, and automated pallet conversion systems.
- Compliance & Quality Assurance: Serve as the Primary Subject Matter Expert (SME) during internal and regulatory audits (FDA/EMA) for warehousing, material handling, cold-chain integrity, and distribution processes.
- Deviation Management & Continuous Improvement: Support and / or own quality events, lead root-cause investigations into logistics deviations or temperature excursions, and implement CAPAs utilizing Lean Six Sigma principles.
- Operational Performance Monitoring: Monitor daily intralogistics KPIs, optimize dock-to-stock and kitting cycle times, and resolve throughput bottlenecks in material flow between the warehouse and production suites.
- Data Integrity & Change Control: Manage logistics change controls, maintain SAP EWM master data, and ensure data integrity across all automated logistics platforms.
- Develop Data Visualization Strategy: Partner with IT/OT and the OpEx teams to develop a strategy for data visualization for real time management of logistics operations..
Key Skills, Abilities, and Competencies
- Technical Mastery: Deep technical expertise in SAP S/4HANA and Extended Warehouse Management (EWM) systems, along with hands-on operational experience with automated warehouse systems (ASRS, AGVs, AMRs, WCS, and high-speed material conveyance).
- Regulatory & Compliance Standards: Expert knowledge of global cGMP standards, GDP (Good Distribution Practice), 21 CFR Part 11/Annex 11, and Annex 1 cold-chain requirements.
- Process Leadership: Proven experience leading root-cause investigations, CAPA development, FMEA/risk assessments, and Lean Six Sigma continuous improvement projects.
- Agility & Innovation: Thrive in ambiguous, dynamic greenfield startup environments with an unwavering commitment to patient safety and quality-first operational excellence.
Who You Are
- Education: Bachelors degree (BSc) in Industrial Engineering, Supply Chain Management, Logistics, Operations, or a related scientific/technical discipline required.
- Years of experience: Minimum of 6+ years (SE5) or 8+ years (SE6) of progressive experience in logistics, intralogistics engineering, or materials management within cGMP-regulated environments (Pharmaceutical, Biotech, or Medical Device required).
- Other: Proven experience in greenfield startup operational readiness and qualification of automated systems.
Other Job Requirements- Shift Schedule: Standard Day Shift (Monday 6Friday) during pre-launch build-out and routine operations.
- Travel Requirements: Up to 25% domestic/international travel required during the pre-launch/commissioning phase for vendor acceptance testing, technology benchmark visits, and training. Post-launch travel stabilizes at ~10%.
Relocation Assistance is not available for this role.
The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $98,600 - $183,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
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