Principal MES Engineer, CVRM (Holly Springs)

ITOT supports Pharma Technical Manufacturing (PTM), which manages all aspects of end-to-end drug substance and drug product manufacturing and supply. From raw material to final medicine, we contribute to delivering Roche’s ground-breaking therapies to over 120 million patients worldwide. This role is part of a new manufacturing site in Holly Springs, North Carolina, focused on large-volume, low-cost drug product manufacturing.

About the role

As a Principal MES Engineer, you will participate in greenfield project execution and support the facility post-go-live. The role focuses on Pharmasuite recipe authoring with growth opportunities in broader MES responsibilities. Initially, you will work remotely and onsite (first at the General Planner’s office, later at the construction site/plant), transitioning to full-time on-site work once the facility is operational. Travel of up to 30% is expected during the project phase.

Responsibilities

• Provide Manufacturing Execution Systems (Rockwell PharmaSuite) capabilities, including generating qualification protocols and maintaining system validation.
• Initial Project Focus: Participate in Basic Design, Detailed Design, and Facility Startup, with a focus on Recipe Authoring (Master Recipes/Workflows) and core system configuration.
• Lifecycle Transition: Provide long-term lifecycle support for the 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 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 post-go-live.

Requirements

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred).
• Minimum of 8 years of applicable MES experience, preferably in drug product functions.
• Direct experience in project execution followed by 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 SQL database management, interface middleware, and server-level troubleshooting.
• Startup Experience: Knowledge of biopharmaceutical manufacturing, design, or construction, particularly 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 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 (URS, PRS, FS, DS).
• Collaboration: Intellectual curiosity and a passion for value-adding technology while partnering effectively with stakeholders.

Pay

The expected salary range for this position in Holly Springs, NC is $95,200 - $176,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors. A discretionary annual bonus may be available based on individual and company performance.

Benefits

This position qualifies for the benefits detailed at the provided link. Relocation benefits are not available for this role.