Beam Therapeutics
Engineer II/Senior Engineer I, Automation and MES
Durham, NC · Senior · Full-time
Sponsorship not specified$140k-$185kDetected 2 days ago
C++SAPSupply ChainLogisticsERPGMPFDA RegulatoryCRISPRMedical DevicesLeadershipCommunicationCollaboration
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odds of building a lasting career here
59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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Green-card filing pattern in this occupation
Context, not a finding about this posting: of this employer's 3 green-card filings in this occupation, 100% were for a worker who already held the job.
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About the role
- 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.
- 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.
Responsibilities
- 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.
- 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
- 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.
Requirements
- BS degree in Engineering or a related technical discipline, or equivalent practical experience.
- Engineer II: typically 6+ years of relevant automation/MES experience.
- Senior Engineer I: typically 8+ years, including demonstrated technical leadership of an MES or automation program.
- Working knowledge of computer system validation and data integrity expectations (GAMP 5, FDA 21 CFR Part 11, EU Annex 11, ALCOA+).
- Excellent organizational, verbal, and written communication skills, with the ability to communicate effectively within cross-functional teams and to management.
- High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
- 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.
- Previous experience with Agile or LEAN delivery methods.
- Required
- Engineer II: typically 6+ years of relevant automation/MES experience. Senior Engineer I: typically 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
- Direct experience authoring, configuring, or validating electronic batch records and master recipes in a regulated manufacturing environment.
- Experience in a biotechnology, pharmaceutical, or medical device manufacturing environment.
- Ability to work on multiple projects and manage various priorities and timelines, and to adapt quickly to changing circumstances.
- 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
Nice to have
- 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.
Compensation
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.
Company info
- As part of the engineering team, further develop and execute the long-range automation, MES, and digital manufacturing strategy.
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