Roche · 17 hours ago
Senior MES Engineer, CVRM (Holly Springs)
Holly Springs
Full-time
Hybrid
Mid, Senior Level
$79K/yr - $146K/yr
5+ years expRoche is a leading company in the pharmaceutical industry, and they are seeking a Senior MES Engineer to support their new manufacturing site in Holly Springs, North Carolina. The role focuses on Manufacturing Execution Systems (MES) capabilities, including recipe authoring and system implementation for drug product manufacturing processes.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
Participate in Basic Design, Detailed Design, and Facility Startup, specifically focused on Recipe Authoring (Master Recipes/Workflows) and core system configuration
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
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
Qualification
Required
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
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
Knowledge of biopharmaceutical manufacturing, design, or construction, specifically in a Greenfield/Facility Startup environment
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
Preferred
Direct experience in project execution followed by a transition into operational lifecycle support is highly preferred
Benefits
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.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and Group Vice President, Computational Science and Informatics R&D
Recent News
2026-02-03
2026-02-03
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