Principal Automation Engineer

Principal Automation Engineer - Warehouse Automation (Holly Springs)

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. 

The Opportunity

ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low-cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). 

Principal Automation Engineer is being hired to participate in Greenfield Project execution and then support the facility after going live.

Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at construction site/plant). You will transition to local full-time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.

The Principal Automation Engineer - Warehouse Automation is responsible for the technical integrity, reliability, and optimization of the automated material handling systems within the Holly Springs facility. This role serves as the subject matter expert for the Körber K.One.X (Warehouse Control System), high-density Automated Storage and Retrieval System (AS/RS systems), and the Automated Guided Vehicle (AGV) fleet. You will bridge the gap between physical hardware and the digital warehouse layer, ensuring that pharmaceutical stock moves seamlessly and safely through the production lifecycle while maintaining strict GxP compliance. The role will also have responsibilities for Robotics Fleet management System that may be shared with Site Robotics Engineer. Leading automation impacting projects with large and/or complex scope and Driving strategic initiatives to improve business processes are also expected.

Key Responsibilities:

Operational System Maintenance (AS/RS & WCS)

• System Health Monitoring: Monitor the daily performance of the Körber K.One.X (WCS) and AS/RS, proactively identifying "stuck" telegrams or queue bottlenecks before they impact production output.

• L2/L3 Technical Support: Act as the highest internal escalation point for complex automation failures. Troubleshoot the handshake between PLC layers and the WCS to resolve hardware-software "mismatches" in real-time.

• Disaster Recovery: Maintain and periodically test the system recovery procedures for the WCS and PLC configurations to ensure rapid restoration of the warehouse flow in the event of a server or network failure.

AGV Fleet & Traffic Management

• Fleet Availability: Manage the daily operational readiness of the AGV fleet, overseeing battery health, charging station rotations, and sensor calibration to ensure 99%+ fleet availability.

• Dynamic Traffic Tuning: Adjust FMS (Fleet Management System) parameters (e.g., zone blocking, speed limits, or path priorities) based on shifting daily operational volumes to prevent congestion in high-traffic corridors.

• Safety Integrity: Conduct routine operational audits of AGV safety fields and emergency stop circuits to ensure the equipment continues to operate within its validated safety envelope.

• Manage Site Robotics Fleet Management Systems in partnership with future Robotics functions at the site.

IT/OT Bridge & Data Integrity

• Interface Oversight: Monitor the SAP EWM-to-WCS (Black Box) message logs (IDocs/Web Services), resolving data discrepancies to ensure that the physical location of pharmaceutical stock always matches its digital twin in SAP.

• Audit Trail Compliance: Ensure that all automated logs and event data required by 21 CFR Part 11 are accurately captured, archived, and available for regulatory inspections or quality audits.

• Continuous Optimization: Analyze OEE (Overall Equipment Effectiveness) data from the WCS and AGV systems to propose small-scale logic adjustments that improve cycle times and reduce mechanical wear and tear.

Who You Are

• Bachelor’s degree in Chemical, Mechanical, Electrical, or Computer Science or a related discipline and 8 years of applicable automation and/or instrument and control system experience preferably majority in drug product function. Or, Master's degree in Engineering or a related discipline and 6 years of applicable automation and/or instrument and control system experience preferably majority in drug product function.

• 5 years in the pharmaceutical/biotech industry/GMP experience is highly preferred.

• 24X7 on call support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required.

Technical Skills:

• Proficiency in troubleshooting PLCs (Siemens TIA Portal or Rockwell Automation) and their communication protocols (Profinet/EtherNet/IP).

• Strong understanding of SAP EWM or similar WMS interfaces (IDocs, queues, and RFC calls).

• Familiarity with AGV navigation technologies (Laser, Natural, or Magnetic) and FMS software.

• Knowledge of GAMP5 standards and 21 CFR Part 11 requirements is highly preferred.

Soft Skills:

• Analytical mindset with the ability to perform root-cause analysis under production pressure.

• Excellent communication skills to translate complex technical issues for cross-functional stakeholders in Logistics and Quality.

Physical Requirements:

• Ability to work in a high-density warehouse environment, which may include working at heights or in proximity to moving automated machinery.

• On-call support for 24/7 warehouse operations.

The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $95,200 - $176,800.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are not available for this job posting.

#CVRM

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.

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