Engineer I/II, Automation and MES

Position Overview:

Beam is looking for a highly energetic Engineer I/II, 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. 
• Develop and maintain requirement specifications, functional specifications, design specifications, and guidelines for automation and MES systems. 
• As part of the engineering team, further develop and execute the long-range automation, MES, and digital manufacturing strategy. 
• Provide technical expertise and assist in the execution of automation capital improvement and compliance projects, including suite buildouts and capacity expansion. 
• Mentor junior engineers and contract resources, and document system knowledge so that critical MES expertise is shared across the team. 
• Cultivate Beam’s culture and our values-driven organization, focused on our people. 
• Ensure safety, quality, compliance, efficiency, and sustainability throughout our engineering, automation, and cGMP operations. 

Qualifications:

Required 

• BS degree in Engineering or a related technical discipline, or equivalent practical experience. 
• Engineer I: minimum of 10 years of relevant automation/MES experience. Engineer II: minimum of 12 years, including demonstrated technical leadership of an MES or automation program. 
• Demonstrated hands-on experience with the design, configuration, testing, and deployment of a GMP MES platform. Rockwell PharmaSuite strongly preferred; Emerson Syncade, Korber PAS-X, Tulip, or Apprentice experience will be considered. 
• Direct experience authoring, configuring, or validating electronic batch records and master recipes in a regulated manufacturing environment. 
• Working knowledge of computer system validation and data integrity expectations (GAMP 5, FDA 21 CFR Part 11, EU Annex 11, ALCOA+). 
• Experience in a biotechnology, pharmaceutical, or medical device manufacturing environment. 
• Excellent organizational, verbal, and written communication skills, with the ability to communicate effectively within cross-functional teams and to management. 
• Ability to work on multiple projects and manage various priorities and timelines, and to adapt quickly to changing circumstances. 
• High degree of customer focus (internal/external) and demonstrated collaboration in a team environment. 
• Results oriented, with the ability to demonstrate resiliency, ownership, and drive. 
• Ability to manage commitments for self while displaying an eagerness to learn and continuously improve. 

Preferred 

• Cell and gene therapy or autologous / patient-specific manufacturing experience, including chain-of-identity and chain-of-custody requirements. 
• Experience supporting a BLA filing, pre-license inspection (PLI/PAI), PPQ campaign, or commercial go-live of a validated MES. 
• Experience with MES-to-ERP integration (SAP), and with LIMS, CMMS, and historian (PI) interfaces. 
• Experience with DeltaV, PI, and Ignition. 
• Capital project, start-up, and manufacturing support experience. 
• Previous experience with Agile or LEAN delivery methods.