Principal MES Engineer, CVRM (Holly Springs)
About The Position
The Principal MES Engineer, CVRM role is part of the ITOT (Information Technology Operations) team supporting Pharma Technical Manufacturing (PTM). PTM is responsible for end-to-end drug substance and drug product manufacturing and supply. A new manufacturing site is being constructed in Holly Springs, North Carolina, focusing on large volume, low-cost Drug Product manufacturing. The ITOT team will own and operate the Manufacturing Technology stack at this site, working with Global IT. This role is crucial for participating in the Greenfield Project execution, specifically focusing on Pharmasuite recipe authoring, and will subsequently support the facility after it goes live. The position involves a mix of remote and onsite work during the project phase, with a transition to full-time on-site work once the buildings and equipment are ready. Travel of up to 30% is expected during the project phase.
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 with a majority in drug product functions.
- Deep expertise with MES System implementation and Recipe Authoring, specifically in the Rockwell PharmaSuite platform.
- Demonstrated experience in providing long-term operational support, including patch management, system upgrades, and configuration control.
- Ability to carry out or learn System Engineering responsibilities, including underlying database management (SQL), interface middleware, and server-level troubleshooting.
- Expert knowledge of Good Manufacturing Practices (GMP), 21 CFR Part 11, GAMP 5, and Data Integrity principles.
- Knowledge of Manufacturing Execution Systems integration with enterprise systems such as SAP (Aspire), LIMS, and Data Historians.
- Proven ability to produce and review critical design specification documents, including URS, PRS, FS, and DS.
- Exhibits intellectual curiosity and a strong passion to bring value-adding technology to the business while partnering effectively with key stakeholders.
Nice To Haves
- Direct experience in project execution followed by a transition into operational lifecycle support is highly preferred.
- Knowledge of biopharmaceutical manufacturing, design, or construction, specifically in a Greenfield/Facility Startup environment is highly preferred.
Responsibilities
- Provide Manufacturing Execution Systems (Rockwell PharmaSuite) capabilities to the ITOT/MES Group, including generating qualification protocols and maintaining the validated state of systems.
- Participate in Basic Design, Detailed Design, and Facility Startup, specifically focused on Recipe Authoring (Master Recipes/Workflows) and core system configuration.
- Provide long-term lifecycle support for the newly built facility with respect to the manufacturing execution systems for process, utility, and building systems.
- Lead the design and implementation of Recipe Authoring for drug product manufacturing processes in a GMP environment.
- Support MES System implementation, including system architecture components and interfaces to partner systems (SAP, LIMS, Automation).
- Act as the MES lead for equipment/software FAT, SAT, field testing, and commissioning.
- Support plant operations to assess discrepant events, troubleshoot automation issues, and provide real-time on-floor support.
- Execute or learn to execute system administration, user access management, and application performance monitoring.
- Participate in a 24/7 on-call environment to meet business continuity requirements after the facility goes live.
Benefits
- Discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
