Senior MES Automation Engineer (Syncade) — GMP Expert

Biogen; North Carolina; On-site; USD 93,000 - 121,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

Wellness programs

Paid vacation and year-end shutdown

401(k) with company match

Tuition reimbursement

Job summary

Biogen is seeking an experienced Senior Automation Engineer I to join the Automation Systems Engineering team at the RTP site. You will act as the Syncade (MES) system administrator and SME, ensuring reliability, supporting manufacturing execution, and driving continuous improvement in a GMP environment.

You will own Syncade application infrastructure, enable eBR workflows, manage access and audits, and lead root-cause investigations for MES-related deviations.

Qualifications

• Bachelor’s degree in Engineering.
• 5–8+ years of automation engineering in a regulated environment (GMP preferred).
• Minimum of 3 years of experience with Syncade/MES Infrastructure, workflows, eBR design, and manufacturing process support.
• Strong understanding of GxP compliance, data integrity, and change control processes.
• Proven ability to independently troubleshoot and resolve complex technical issues.

Responsibilities

• Act as system administrator/SME for Syncade (MES), including configuration, maintenance, troubleshooting, and lifecycle management.
• Own and support Syncade Application and the relevant infrastructure to enable electronic batch record (eBR) workflows, recipe configuration, and exception handling.
• Ensure system availability, performance, and data integrity to support GMP manufacturing operations.
• Lead root cause investigations and implement corrective/preventive actions for MES-related deviations.
• Manage user access, security roles, and audit trail reviews in compliance with GxP and cybersecurity requirements.
• Execute and support change controls, including system updates, enhancements, and validation deliverables (IQ/OQ/PQ).
• Drive continuous improvement efforts to enhance system usability, reliability, and operational efficiency.
• Support integration and data flow between Syncade and other automation and Enterprise systems, e.g. DeltaV, PI, and Infobatch, CMMS, Oracle, Veeva, LIMS.
• Provide technical support during manufacturing operations, including off-hours support as required.

Skills

Syncade/MES

GxP compliance

System troubleshooting

Automation engineering

Data integrity

Education

Bachelor's degree in Engineering

Tools

Emerson DeltaV

AVEVA PI

Infobatch

Job description

Biogen is seeking an experienced Senior Automation Engineer I to join the Automation Systems Engineering team at the RTP site. You will act as the Syncade (MES) system administrator and SME, ensuring reliability, supporting manufacturing execution, and driving continuous improvement in a GMP environment.

You will own Syncade application infrastructure, enable eBR workflows, manage access and audits, and lead root-cause investigations for MES-related deviations.