Senior Engineer II/III, Automation and MES
Beamtherapeutics · Durham, NC
About this role
**Company Overview** Beam Therapeutics is a biotechnology company building a fully integrated platform for precision genetic medicines, anchored by base editing technology. Beam is values-driven and focused on delivering life-long cures for patients. **Position Overview** Beam is seeking a highly energetic **Sr. Engineer II / III, Automation and MES** with **GMP manufacturing experience**. You will design, install, configure, maintain, and validate **Rockwell PharmaSuite** MES systems, while also supporting other automation platforms including **DeltaV, PI, and Ignition**. This role is a core team position on the Engineering and Facilities team supporting the development and maintenance of automation systems at Beam’s new multi-modality site in **Durham / RTP, NC**. You will help shape Beam’s **MES Master Recipes** and broader automation strategy to support **clinical and commercial** cell and gene therapy manufacturing. **Key Responsibilities** - Serve as the site subject matter expert for **Rockwell FactoryTalk PharmaSuite MES** (configuration, master recipe/workflow authoring, exception handling, defect triage) - Lead design, implementation, and lifecycle management of **electronic batch records (EBR)** (phase design, calculations, transitions, CPP/process limits, electronic signature flows) - Convert paper master batch records into compliant, operator-friendly electronic execution with Manufacturing, MS&T, and Quality - Own **MES change control end-to-end** (impact assessment, specifications, IQ/OQ/PQ test protocol authoring/execution, deviation documentation, requirements traceability support) - Support MES implementation and lifecycle (architecture, platform components, interfaces to SAP, LIMS, CMMS, PI, and patient logistics chain-of-identity/chain-of-custody systems) - Support deployment of PharmaSuite MES across new/existing suites, processes, and products as capacity scales - Support inspection and licensure readiness (mock pre-license inspection runs, audit trail review, data integrity controls per **21 CFR Part 11** and **EU Annex 11**, business continuity procedures) - Provide floor-side support, hypercare, and operator training during go-live; translate feedback into recipe/workflow improvements - Troubleshoot automation issues and participate in an on-call/after-hours GMP support rotation - Support lifecycle management of other automation systems (**DeltaV, PI, Ignition**) - Develop and maintain requirement/functional/design specifications and guidelines for automation and MES systems - Contribute to long-range automation, MES, and digital manufacturing strategy - Assist with automation capital improvement and compliance projects (suite buildouts, capacity expansion) - Mentor junior engineers/contract resources and document system knowledge - Ensure safety, quality, compliance, efficiency, and sustainability across engineering and cGMP operations **Qualifications** **Required** - BS in Engineering (or related technical discipline) or equivalent practical experience - **Engineer II:** 6+ years relevant automation/MES experience. **Sr. Engineer III:** 8+ years, including demonstrated technical leadership of an MES/automation program - Hands-on experience designing/configuring/testing/deploying a **GMP MES** platform (Rockwell PharmaSuite strongly preferred; Emerson Syncade, Körber PAS-X, Tulip, or Apprentice considered) - Experience authoring/configuring/validating **electronic batch records and master recipes** in reg
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