Senior Automation & MES Engineer - GMP Cell Therapy

Beam Therapeutics Inc.; North Carolina; On-site; USD 140,000 - 185,000; Full time

Job summary

Beam Therapeutics Inc. is seeking a Sr. Engineer II/III, Automation and MES to design, install, configure, maintain, and validate Rockwell PharmaSuite MES for GMP cell therapy manufacturing at the Durham/RTP, NC site.

The role supports DeltaV, PI, and Ignition and helps shape Beam’s MES strategy for clinical and commercial programs. You will lead electronic batch records development, lifecycle management, and change controls while partnering with Manufacturing, MS&T, Quality, and IT to ensure

Qualifications

• BS degree in Engineering or a related technical discipline, or equivalent practical experience.
• Engineer II: minimum of 6 years of relevant automation/MES experience. Sr. Engineer III: minimum of 8 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.

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.

Skills

Automation experience

MES experience

Rockwell PharmaSuite

GAMP 5

FDA 21 CFR Part 11

Cross-functional collaboration

Education

BS degree in Engineering

Tools

Rockwell PharmaSuite

Emerson Syncade

Korber PAS‑X

Tulip

Apprentice

SAP

LIMS

CMMS

PI

Ignition

DeltaV

Job description

Beam Therapeutics Inc. is seeking a Sr. Engineer II/III, Automation and MES to design, install, configure, maintain, and validate Rockwell PharmaSuite MES for GMP cell therapy manufacturing at the Durham/RTP, NC site.

The role supports DeltaV, PI, and Ignition and helps shape Beam’s MES strategy for clinical and commercial programs. You will lead electronic batch records development, lifecycle management, and change controls while partnering with Manufacturing, MS&T, Quality, and IT to ensure