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Holly Springs, North Carolina, United States
Hybrid
Not Available
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 Springs, 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).
The Principal MES Engineer is being hired to participate in Greenfield Project execution and subsequently support the facility after going live. Focus of the role is Pharmasuite recipe authoring with expectation to grow in MES beyond authoring.
Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at the construction site/plant). You will transition to local full-time on-site work once site buildings are constructed and equipment is delivered. Travel of up to 30% is expected during the project phase.
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, specifically focused on Recipe Authoring (Master Recipes/Workflows) and core system configuration.
Lifecycle Transition: Focuses on providing long-term lifecycle support for the newly built facility with respect to the 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 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.
Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred).
Minimum of 8 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.
Knowledge, Skills, and Abilities
PharmaSuite MES Expertise: Deep expertise with MES System implementation and Recipe Authoring, specifically in the Rockwell PharmaSuite platform.
MES Lifecycle Support: Demonstrated experience in 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 is highly preferred.
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.
The expected salary range for this position based on the primary location of Holly Springs, NC 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.
Relocation benefits are not available for this job posting.
#CVRM
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