Company Overview

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview

Beam is looking for a highly energetic Engineer II/Senior Engineer I, Automation and MES with GMP manufacturing experience focused on design, installation, configuration, maintenance support, and validation of Rockwell PharmaSuite system. Additionally, the role will support other automation systems including DeltaV, PI, and Igniton. The candidate will be a core team member for the Engineering and Facilities team developing and maintaining automation systems at the new multi-modality site in Durham / RTP, NC. This is a fantastic opportunity to help continue to develop and grow Beam manufacturing and automation long -term strategy. The successful candidate will show initiative in helping with the development of Beam’s MES Master Recipes and overall automation strategy to support clinical and commercial manufacturing of the current cell and gene therapy manufacturing modality platforms. They will provide technical expertise and assistance in execution of Capital Improvement and Compliance projects. They will also possess the ability to successfully interface with multidisciplinary teams building strong cross functional relationships and engage and collaborate with external partners in IT, supply chain, process development, manufacturing operations, quality, validation, and finance.

Responsibilities:

Serve as the site subject matter expert for Rockwell FactoryTalk PharmaSuite MES, including configuration, master recipe and workflow authoring, exception handling, and defect triage.
Lead the design, implementation, and lifecycle management of electronic batch records (EBR) for clinical and commercial cell therapy manufacturing processes, including phase design, calculations, transitions, CPP/process limits, and electronic signature flows.
Convert paper master batch records into compliant, operator-friendly electronic execution in partnership with Manufacturing, MS&T, and Quality.
Own MES change control end to end: impact assessment, requirement/functional/configuration specifications, test protocol authoring and execution (IQ/OQ/PQ), deviation documentation, and requirements traceability matrix support.
Support MES system implementation and lifecycle, including system architecture, platform components, and interfaces to partner systems (SAP, LIMS, CMMS, PI, and patient logistics chain-of-identity / chain-of-custody systems).
Support the deployment of PharmaSuite MES to new and existing suites, processes, and products as the site scales capacity across modalities.
Support inspection and licensure readiness, including mock pre-license inspection runs, audit trail review, data integrity controls per 21 CFR Part 11 and EU Annex 11, and MES business continuity procedures.
Provide floor-side support, hypercare, and operator training during go-live; translate operator feedback into practical recipe and workflow improvements.
Support plant operations and troubleshoot automation issues, including participation in an on-call / after-hours support rotation for GMP manufacturing.
Support development and lifecycle management of other automation systems, including DeltaV, PI, and Ignition.