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Biogen

Develops therapies for neurological disorders

Sr Engineer I - Automation, Syncade MES

Regulatory & Quality (Life Sciences)Updated on Nov 10
Full-timeResearch Triangle Park, Durham, NC, USAIn-person

About the Job

Requirements

  • A bachelor's degree in Engineering is required.
  • At least 5 years of automation engineering experience in a regulated environment; GMP experience is preferred.
  • At least 3 years of experience with Syncade/MES infrastructure, workflows, electronic batch record design, and manufacturing process support.
  • Strong understanding of GxP compliance, data integrity, and change-control processes.
  • Ability to independently troubleshoot and resolve complex technical issues.

Responsibilities

  • Act as the system administrator and subject matter expert for Syncade (MES), including configuration, maintenance, troubleshooting, and lifecycle management.
  • Own and support the Syncade application and relevant infrastructure for electronic batch record 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 and 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, including DeltaV, PI, Infobatch, CMMS, Oracle, Veeva, and LIMS.
  • Provide technical support during manufacturing operations, including off-hours support as required.

Desired Qualifications

  • Experience with Emerson DeltaV (DCS) integration and support.
  • Experience with the AVEVA PI System for data collection and analytics.
  • Familiarity with Infobatch for batch reporting.
  • Participation in system upgrades, technology transfers, or manufacturing modernization initiatives.

About the Company

Biogen

Develops therapies for neurological disorders

Biogen is a global biotechnology company focused on neuroscience. It discovers, develops, and delivers therapies for neurological disorders, such as multiple sclerosis and other neurodegenerative diseases. Its product process starts with research and development to identify potential drugs, followed by clinical testing and regulatory approval, ultimately leading to commercialization and patient treatment. Biogen differentiates itself through a long history (founded in 1978), a deep specialization in neuroscience, and an integrated pipeline that moves ideas from discovery to approved medicines, aiming to create value for shareholders while helping communities. The company’s goal is to advance therapies for neurological diseases to improve patients’ lives and generate sustainable value for stakeholders.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
1978

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