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
Ensure architecture supports scalability, cybersecurity, data integrity, and multi-product flexibility
Lead the creation, review, and approval of: URS (User Requirements Specifications), FRS (Functional Requirements Specifications), DS / DDS (Design Specifications), Functional & Control Narratives, Recipe Design Documentation (ISA-88 compliant)
Configure, program, and deploy Digital System within the manufacturing environment
Support integration of OEM skids: bioreactors, chromatography systems, filtration skids, CIP/SIP, and fill finish equipment
Lead deviation investigations, CAPAs, and risk assessments related to Digital systems
Serve as SME for troubleshooting, system optimization, batch failure analysis, and performance enhancements
Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams to deliver integrated system solutions
Mentor junior engineers and act as technical SME 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
Understanding multisite standards for global manufacturers
Applicants must be authorized to work in the United States on a full-time basis.

Lead Automation Engineer, MES – Digital Systems

Key skills