Business Process Specialist - Logistics Process & Compliance, CVRM

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 99,000 - 183,000; Full time

Job summary

Genentech in Holly Springs, NC, seeks a logistics/ intralogistics expert to lead pre-startup build-out and post-launch operations. You will ensure end-to-end intralogistics processes, data integrity, and regulatory compliance across automated systems, drive continuous improvement, and collaborate with cross-functional teams.

You will bridge logistics engineering, quality, and digital tech, shaping the site’s operational readiness and long-term efficiency in a fast-paced, startup-like environment.

Qualifications

• Bachelor's degree in Industrial Engineering, Supply Chain Management, Logistics or related field.
• Minimum 6+ years in logistics or intralogistics engineering in cGMP environments.
• Experience with greenfield startup readiness and qualification of automated systems.
• Strong knowledge of regulatory standards (cGMP, GDP, 21 CFR Part 11).

Responsibilities

• Operational Readiness & System Build-Out for SAP S/4HANA (EWM) and automated warehousing systems.
• Define site-level intralogistics processes, PFEP/PFEF, and material routing for raw materials, WIP, and consumables.
• Author SOPs, validation protocols, and commissioning docs for automated logistics and cold-chain storage.
• Support equipment qualification and commissioning with automation vendors and engineering teams.
• Serve as SME during internal and regulatory audits (FDA/EMA) for warehousing and distribution.
• Lead deviation management, CAPA, and Lean Six Sigma driven improvements.
• Monitor KPIs, optimize dock-to-stock, and resolve throughput bottlenecks.
• Manage change control, SAP EWM master data, and data integrity across platforms.
• Develop data visualization strategy with IT/OT and OpEx teams.

Skills

SAP S/4HANA

EWM

ASRS

AGVs

AMRs

WCS

cGMP

GDP

21 CFR Part 11/Annex 11

Annex 1 cold-chain

Lean Six Sigma

CAPA

Root-cause investigations

Education

BSc Industrial Engineering

BSc Supply Chain Management

BSc Logistics

BSc Operations

Tools

SAP S/4HANA

EWM

ASRS

AGVs

AMRs

WCS

Job description

Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.

Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation. Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.

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 +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.
• 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.

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.

Link to Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.