Business Process Specialist - Logistics Process & Compliance, CVRM

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 +8°C, -20°C, 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: Bachelor’s 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–Friday) 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.