Engineer II/Senior Engineer I, Automation and MES

The posting, as Beam Therapeutics wrote it

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

[…]
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.

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.

Beam Pay Range
$140,000 — $185,000 USD