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AGC Biologics

End-to-end biopharma CDMO for gene therapies

OT Operations Specialist

System AdministrationConfirmed live in the last 24 hours
Full-timeSøborg, DenmarkNo salary listed

About the Job

Requirements

  • A Bachelor's degree in Engineering, IT, Automation, Computer Science, or a similar field.
  • At least 5 years of experience within OT, Manufacturing IT, Automation, or Life Sciences.
  • Strong understanding of GMP-regulated environments.
  • Experience managing Change Controls, Deviations, CAPAs, and validation activities.
  • Experience working with OT infrastructure, servers, virtualization, and industrial networking.
  • Experience working with manufacturing systems such as SCADA, Historian, MES, or similar platforms.
  • Strong stakeholder management and communication skills.

Responsibilities

  • Support and maintain OT infrastructure and manufacturing systems in a GMP-regulated production environment.
  • Manage OT servers, virtualization platforms, industrial networks, and system integrations.
  • Troubleshoot complex OT-related issues across manufacturing environments.
  • Collaborate closely with Automation, Engineering, Manufacturing, Quality, and IT teams to ensure reliable operations.
  • Ensure OT systems remain compliant with GMP requirements and data integrity principles (ALCOA+).
  • Drive and support Change Controls (CRs), Deviations, CAPAs, and Risk Assessments related to OT systems.
  • Support audits, inspections, and periodic system reviews.
  • Contribute to Computer System Validation (CSV) activities, including IQ/OQ documentation and execution.
  • Support integration between manufacturing systems and business systems.
  • Participate in digitalization initiatives involving MES, Historian, SCADA, ERP, and related manufacturing platforms.
  • Support industrial communication technologies such as OPC UA, Modbus, and Profinet.
  • Drive continuous improvements and identify opportunities for automation and increased operational efficiency.
  • Support OT cybersecurity initiatives and contribute to maintaining a secure technology environment.
  • Manage system lifecycle activities including upgrades, patching, backup, disaster recovery, and access management.
  • Ensure systems remain secure, reliable, and inspection-ready.

Desired Qualifications

  • Experience with MES platforms and manufacturing system integrations.
  • Experience with APIs and data flows between systems.
  • Experience with industrial communication protocols such as OPC UA, Modbus, or Profinet.
  • Experience with OT cybersecurity frameworks and best practices.
  • Experience supporting FDA, EMA, or other regulatory inspections.

About the Company

AGC Biologics

End-to-end biopharma CDMO for gene therapies

AGC Biologics is a global contract development and manufacturing organization (CDMO) that develops and manufactures biopharmaceuticals, including therapeutic proteins, plasmid DNA, viral vectors, and cell therapies. It offers end-to-end services from early development through commercial-scale manufacturing, with fast-track options for orphan drugs and rare diseases. The company runs cGMP-compliant facilities across the US, Europe, and Asia, recently expanding with a Longmont, Colorado site focused on cell and gene therapies. Its goal is to help biopharma partners bring new treatments to market efficiently and safely by providing integrated development and manufacturing, supported by its international footprint and project acceleration capabilities.

Company size
1,001-5,000
Company stage
Acquired
Total funding
$557.7M
Headquarters
Bothell, WA
Founded
2001

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