Provide subject matter expertise in the design, implementation, and lifecycle management of digital systems across biologics, pharmaceutical, and novel therapy manufacturing facilities.
Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers)
Develop product recipe strategies across the full application layer of ERP, MES and DCS Batch.
Create ISA-88/ISA-95-aligned architecture documents.
Ensure architecture supports scalability, cybersecurity, data integrity, and multi-product flexibility.
Lead documentation processes like URS, FRS, DS, and various design specifications.
Configure, program, and deploy Digital System within the manufacturing environment.
Provide manufacturing operations support through troubleshooting and optimization.
Collaborate cross-functionally with various teams to deliver integrated system solutions.
Mentor junior engineers and act as a technical subject matter expert during audits and regulatory inspections.

Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related)
Minimum 9-12+ years in automation engineering within GMP life sciences (biotech, pharma, ATMP)
Expert-level experience with various MES platforms, Data Repositories, Serialization and integration to manufacturing applications (ERP, LIMS, CMMS, etc)
Proven ability to author, interpret, and own URS/FRS/DS documentation
Experience designing system applications and data flows across the full spectrum of manufacturing applications
Strong understanding of ISA-88 batch control, ISA-95 manufacturing hierarchy, and GAMP 5
Hands-on experience supporting biologics and sterile/aseptic manufacturing environments
Applicants must be authorized to work in the United States on a full-time basis
This position may require significant travel to support project and business needs.
Understanding multisite standards for global manufacturers.

Lead Automation Engineer, MES – Digital Systems

Key skills