Senior MES Engineer, CVRM (Holly Springs)

Overview ITOT supports Pharma Technical Manufacturing (PTM), which manages all aspects of end‑to‑end drug substance and drug product manufacturing and supply. PTM delivers Roche’s ground‑breaking therapies to more than 120million patients worldwide from 9 sites. To enable a step‑change in cardiovascular, renal and metabolism care, a new large‑volume, low‑cost drug product manufacturing site will be built in Holly Springs, North Carolina. ITOT will own and operate the manufacturing technology stack there. The SrMES Engineer will participate in greenfield project execution and later support operations after the plant goes live, focused on Pharmasuite recipe authoring with a path to broader MES responsibilities. What You’ll Do This role provides Manufacturing Execution Systems (Rockwell PharmaSuite) capabilities to the ITOT/MES Group, including generating qualification protocols and maintaining the validated state of systems. Initial Project Focus : Participate in basic design, detailed design, and facility startup, focusing on recipe authoring (master recipes/workflows) and core system configuration. Lifecycle Transition : Provide long‑term lifecycle support for the new facility’s manufacturing execution systems for process, utility, and building systems. Recipe Authoring : Lead design and implementation of recipe authoring for drug product manufacturing processes in a GMP environment. System Implementation : Support MES implementation, including system architecture components and interfaces to partner systems (SAP, LIMS, automation). Startup & Commissioning : Act as the MES lead for equipment/software FAT, SAT, field testing, and commissioning. Operational Support : Support plant operations to assess discrepant events, troubleshoot automation issues, and provide real‑time on‑floor support. Systems Management : Execute or learn to execute system administration, user access management, and application performance monitoring. 24/7 Readiness : Participate in a 24/7 on‑call environment to meet business continuity requirements after the facility goes live. Knowledge, Skills, and Abilities PharmaSuite MES Expertise : Deep expertise with MES system implementation and recipe authoring on the Rockwell PharmaSuite platform. MES Lifecycle Support : Demonstrated experience providing long‑term operational support, including patch management, system upgrades, and configuration control. Technical Systems Aptitude : Ability to carry out or learn system engineering responsibilities, including underlying database management (SQL), interface middleware, and server‑level troubleshooting. Startup Experience : Knowledge of biopharmaceutical manufacturing, design, or construction, specifically in a greenfield/facility startup environment. Regulatory Compliance : Expert knowledge of GMP, 21CFRPart11, GAMP5, and data‑integrity principles. Process Integration : Knowledge of MES integration with enterprise systems such as SAP (Aspire), LIMS, and data historians. Technical Documentation : Proven ability to produce and review critical design specification documents, including URS, PRS, FS, and DS. Collaboration : Exhibits intellectual curiosity and a strong passion to bring value‑adding technology to the business while partnering effectively with key stakeholders. Who You Are Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred). Minimum of 5years applicable MES experience, preferably with a majority in drug product functions. Direct experience in project execution followed by transition into operational lifecycle support is highly preferred. Relocation funding is not available for this role. Salary & Benefits Base salary range for the primary location (Holly Springs, NC) is $78,900 – $146,500, determined by 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 described in the company policy. Equal Opportunity Genentech is an equal‑opportunity employer. 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. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr F. Hoffmann-La Roche AG