Engineer II/Senior Engineer I, Automation and MES
Beam Therapeutics
Beam Therapeutics seeks a Senior Engineer II/III to design, implement, and maintain automation and manufacturing execution systems (MES) for precision genetic medicine manufacturing in Durham, NC. The role focuses on Rockwell PharmaSuite configuration, electronic batch records, and cross-functional collaboration to support clinical and commercial cell and gene therapy production.
Responsibilities
- Serve as site subject matter expert for Rockwell PharmaSuite MES configuration and master recipe development
- Design and implement electronic batch records for cell therapy manufacturing processes with compliance controls
- Lead MES change control procedures including specifications, testing, and traceability documentation
- Support system implementation, deployment, and lifecycle management across multiple manufacturing suites
- Provide floor-side support, operator training, and hypercare during production go-live phases
Requirements
- GMP manufacturing experience with validation and compliance expertise
- Advanced proficiency in Rockwell FactoryTalk PharmaSuite MES platform
- Experience with electronic batch record (EBR) design and implementation
- Knowledge of 21 CFR Part 11 and EU Annex 11 data integrity requirements
- Familiarity with DeltaV, PI, or Ignition automation systems
- Change control and system lifecycle management experience
- Strong cross-functional communication and project leadership skills
Vacancy posted 6 days ago
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