Genentech · 11 hours ago
Senior MES Engineer, CVRM (Holly Springs)
Charlotte, NC
Full-time
Hybrid
Mid, Senior Level
$79K/yr - $146K/yr
5+ years expGenentech is a leading biotechnology company focused on delivering innovative therapies to patients. The Senior MES Engineer will participate in the execution of a Greenfield Project and provide long-term lifecycle support for manufacturing execution systems at a new facility focused on drug product manufacturing.
BiotechnologyLife ScienceManufacturing
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
Focus 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.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech 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 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
Chief Executive Officer
Michael Laird
Vice President, Global MSAT Drug Substance Biologics Technology and Commercial Products Support
Recent News
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