Senior MES Engineer, CVRM (Holly Springs)

The opportunity is with ITOT, which supports Pharma Technical Manufacturing (PTM). PTM manages all aspects of end-to-end drug substance and drug product manufacturing and supply—from raw material to final medicine—helping deliver Roche’s ground-breaking therapies to over 120 million patients worldwide. Medicines are produced at 9 global sites, covering all disease areas and dosage forms. To prepare for a step-change in Cardiovascular, Renal, and Metabolism (CVRM) care, PTM is building a new U.S. manufacturing site in Holly Springs, North Carolina. ITOT will own and operate the Manufacturing Technology stack at this greenfield site, focusing on large-volume, low-cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products).

About the role

The Sr MES Engineer will join the Greenfield Project execution team and later support the facility post-go-live, with a focus on Pharmasuite recipe authoring and growth into broader MES responsibilities. Initially, work will be a mix of remote and onsite (first at the General Planner’s office, later at the construction site/plant), transitioning to full-time on-site once buildings and equipment are in place. Up to 30% travel is expected during the project phase.

Responsibilities

• Provide 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, specifically focused on Recipe Authoring (Master Recipes/Workflows) and core system configuration.
• Lifecycle Transition: Provide long-term lifecycle support for the newly built facility’s manufacturing execution systems for process, utility, and building systems.
• Recipe Authoring: Lead the design and implementation of Recipe Authoring for drug product manufacturing processes in a GMP environment.
• System Implementation: Support MES System 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 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.

Requirements

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred).
• Minimum of 5 years of applicable MES experience, preferably with a majority in drug product functions.
• Direct experience in project execution followed by a transition into operational lifecycle support is highly preferred.

Skills

• PharmaSuite MES Expertise: Deep expertise with MES System implementation and Recipe Authoring, specifically in the Rockwell PharmaSuite platform.
• MES Lifecycle Support: Demonstrated experience in 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 Good Manufacturing Practices (GMP), 21 CFR Part 11, GAMP 5, and Data Integrity principles.
• Process Integration: Knowledge of Manufacturing Execution Systems 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.

Pay

The expected salary range for this position based in Holly Springs, NC is $78,900 - $146,500. Actual pay will be 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.

Benefits

This position qualifies for the benefits detailed at Genentech’s benefits page.