Lead Automation Engineer, MES – Digital Systems

📋 Description

• Design system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers)

• Create product recipe strategies across the complete application layer of ERP, MES, and DCS Batch

• Ensure that the architecture accommodates scalability, cybersecurity, data integrity, and multi-product flexibility

• Oversee the development, review, and approval of: URS (User Requirements Specifications), FRS (Functional Requirements Specifications), DS / DDS (Design Specifications), Functional & Control Narratives, and Recipe Design Documentation (ISA-88 compliant)

• Configure, program, and implement Digital Systems within the manufacturing environment

• Facilitate the integration of OEM skids: bioreactors, chromatography systems, filtration skids, CIP/SIP, and fill finish equipment

• Lead investigations on deviations, CAPAs, and risk assessments related to Digital systems

• Act as a Subject Matter Expert (SME) for troubleshooting, system optimization, batch failure analysis, and performance improvements

• Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams to provide integrated system solutions

• Guide junior engineers and serve as a technical SME during audits and regulatory inspections

⛳️ Requirements

• Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or a related field)

• At least 9-12+ years of experience in automation engineering within GMP life sciences (biotech, pharma, ATMP)

• Expert-level knowledge of various MES platforms, Data Repositories, Serialization, and integration with manufacturing applications (ERP, LIMS, CMMS, etc)

• Demonstrated ability to author, interpret, and manage URS/FRS/DS documentation

• Experience in designing system applications and data flows across a wide range of manufacturing applications

• Strong comprehension of ISA-88 batch control, ISA-95 manufacturing hierarchy, and GAMP 5

• Practical experience in supporting biologics and sterile/aseptic manufacturing environments

• Familiarity with multisite standards for global manufacturers

• Candidates must be authorized to work in the United States on a full-time basis.

🏝️ Benefits

• Health insurance

• 401(k) plans

• Paid time off

• Flexible work arrangements

• Professional development opportunities