Genentech

Genentech

Senior MES Engineer, CVRM (Holly Springs)

North Carolina · Senior · Full-time

Sponsorship not specified$79k-$147kDetected 5 days ago
SQLComplianceSAPGMPCollaboration

About the role

  • PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply.
  • 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.
  • 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).

Responsibilities

  • 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.
  • MES Lifecycle Support: Demonstrated experience in providing long-term operational support, including patch management, system upgrades, and configuration control.
  • Startup Experience: Knowledge of biopharmaceutical manufacturing, design, or construction, specifically in a Greenfield/Facility Startup environment.
  • Direct experience in project execution followed by a transition into operational lifecycle support is highly preferred.

Requirements

  • MES Experience: Minimum of 5 years of applicable MES experience, preferably with a majority in drug product functions.
  • 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.
  • Minimum of 5 years of applicable MES experience, preferably with a majority in drug product functions.

Nice to have

  • Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred).

Skills

  • Participate in a 24/7 on-call environment to meet business continuity requirements after the facility goes live.
  • Knowledge, Skills, and Abilities

Compensation

  • The expected salary range for this position based on the primary location of Holly Springs, NC is $78,900 - $146,500.

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.

Equal opportunity

  • equal opportunity employer.
  • If you have a disability and need an accommodation in relation to the online
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This listing is sourced directly from Genentech's careers page and normalized into a canonical job model.