Senior PI Data Engineer — MQTT & GMP Analytics

Data & Analytics Engineer/Senior Data & Analytics Engineer (PI, MQTT and UNS)
The Opportunity

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. Behind every product sold by Roche is Pharma Global Technical Operations (PT).

Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as using new technologies.

• Development and lifecycle management of the data historian and related data systems in a GMP regulated environment.
• Design, configure, and maintain the OSI PI System infrastructure including PI Data Archive, PI Asset Framework (AF), PI Vision, and PI Analysis Service.
• Design and support robust data pipelines, ensuring contextualized data from OSI PI and MQTT sources is available for advanced analytics, predictive modeling, and integration with Level 4 business systems (e.g., ERP, LIMS, PLM).
• Performing application administration (user admin, patching, upgrades, audit support, system and database log review and maintenance).
• Software development in various languages, testing and configuration of COTS or custom applications to support HSP manufacturing systems and support of stakeholders.
• Development and management of standardized Asset Framework (AF) templates, attributes, and hierarchies to represent site equipment and processes consistently.
• Creation and maintenance of operational dashboards and displays in PI Vision to provide real-time visibility for manufacturing, quality, and engineering teams.
• Partnering with IT and Automation teams to ensure high availability, disaster recovery, and cybersecurity compliance of the PI system.
• Drafting and execution of validation documentation (IQ/OQ/PQ) and standard operating procedures (SOPs) for the PI system in accordance with 21 CFR Part 11 and GxP standards.
• Performing routine system maintenance, including upgrades, security patching, and health monitoring to ensure 24/7 reliability.
• Providing technical mentorship and support to system users, helping them leverage PI data for process optimization and troubleshooting.
• Monitoring and analysis of manufacturing data as necessary to provide support for process discrepancies, investigations, validation protocols, process transfers, or equipment troubleshooting.
• Working to identify opportunities to create additional value and improve business processes and patient outcomes, maximize the benefits of standardization of technologies and leverage across sites.
• Executing implementation and delivery of projects on-site IT OT Product Portfolio.
• Assisting in the development of end-user and maintenance training materials.
• Providing diagnostic troubleshooting assistance to maintenance and technicians as required, including off-hour and on-call support.

• Data & Analytics Engineer (PI, MQTT and UNS) Bachelor's degree in Chemical, Electrical, or Computer Engineering, Computer Science, or a related technical discipline.
• 5+ years of experience implementing and managing data and/or analytics solutions.
• H…