Engineer II/Senior Engineer I, Automation and MES

The role

This person will design, install, configure, maintain, and validate Rockwell PharmaSuite systems. They will also support automation systems including DeltaV, PI, and Igniton at a multi-modality site.

What you will do

• Serve as site subject matter expert for Rockwell FactoryTalk PharmaSuite MES
• Lead design, implementation, and lifecycle management of electronic batch records
• Convert paper master batch records into electronic execution
• Own MES change control end to end
• Support MES system implementation and lifecycle
• Support deployment of PharmaSuite MES to new and existing suites
• Support inspection and licensure readiness
• Provide floor-side support, hypercare, and operator training during go-live
• Support plant operations and troubleshoot automation issues via on-call rotation
• Support development and lifecycle management of DeltaV, PI, and Ignition

Required qualifications

• 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
• Demonstrated hands-on experience with the design, configuration, testing, and deployment of a GMP MES platform
• 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
• Ability to work on multiple projects and manage various priorities and timelines
• High degree of customer focus 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

Nice to have

• 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

About the company

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.