OT Operations Specialist – GMP IT for Smart Manufacturing

AGC Biologics A/S; København; Vor Ort; DKK 900.000 - 1.100.000; Vollzeit

Zusammenfassung

AGC Biologics A/S in Søborg, Denmark, seeks an OT Operations Specialist to maintain and improve the Operational Technology landscape in a GMP‑regulated manufacturing environment. You will work at the intersection of technology, manufacturing and quality, ensuring systems are reliable, compliant and ready to support digitalization initiatives.

You will collaborate with Automation, Engineering, Manufacturing, Quality and IT to manage OT infrastructure, servers, virtualization, industrial networks

Qualifikationen

• Bachelor's degree in Engineering, IT, Automation, Computer Science or a similar field.
• 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.

Aufgaben

• Maintain OT infrastructure and manufacturing systems in a GMP-regulated environment.
• Manage OT servers, virtualization platforms, industrial networks and system integrations.
• Troubleshoot OT-related issues across manufacturing environments.
• Collaborate with Automation, Engineering, Manufacturing, Quality and IT teams to ensure reliable operations.
• Support Change Controls, Deviations, CAPAs and validation activities related to OT systems.
• Contribute to CSV activities, including IQ/OQ documentation and execution.
• Support digitalization initiatives involving MES, Historian, SCADA, ERP and related platforms.

Kenntnisse

GMP environments

OT infrastructure

SCADA

Historian

MES

OPC UA

Modbus

Profinet

Change Controls

CAPAs

CSV validation

OT cybersecurity

APIs data flows

Ausbildung

Bachelor's degree in Engineering/IT/Automation/CS

Tools

SCADA

Historian

MES

OPC UA

Jobbeschreibung

AGC Biologics A/S in Søborg, Denmark, seeks an OT Operations Specialist to maintain and improve the Operational Technology landscape in a GMP‑regulated manufacturing environment. You will work at the intersection of technology, manufacturing and quality, ensuring systems are reliable, compliant and ready to support digitalization initiatives.

You will collaborate with Automation, Engineering, Manufacturing, Quality and IT to manage OT infrastructure, servers, virtualization, industrial networks