Location: Søborg, Denmark. Please note that AGC Biologics does not offer relocation assistance. Applicants must already reside in Denmark or the Greater Malmö area in Sweden.
At AGC Biologics, we are constantly developing our manufacturing capabilities to support the delivery of life-changing biologics to patients worldwide. As our new OT Operations Specialist , you will play an important role in maintaining and improving the Operational Technology landscape that supports our GMP-regulated manufacturing environment.
You will work at the intersection of technology, manufacturing, and quality, ensuring that our systems are reliable, compliant, and ready to support future digitalization initiatives. This role offers the opportunity to work with advanced manufacturing technologies while collaborating with experts across Automation, Engineering, Manufacturing, Quality, and IT.
A key role in our Operational Technology landscape
As a OT Operations Specialist , you will help ensure stable and compliant manufacturing systems while supporting continuous improvements across our digital production environment.
Your responsibilities will include:
Operational Technology
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.
GMP & Compliance
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.
Digitalization & Integration
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.
Security & Lifecycle Management
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.
A collaborative environment with room to make an impact
You will join a team where collaboration, knowledge sharing, and continuous improvement are key parts of how we work. You will work closely with colleagues across different functions and act as a trusted technology partner to Manufacturing, Engineering, Quality Assurance, and IT.
Success in this role means maintaining a stable and compliant OT environment, driving GMP-related improvements, strengthening system integrations, and identifying opportunities where technology can improve our manufacturing processes.
We are looking for someone who brings
You have a strong interest in combining technology with manufacturing and thrive in an environment where quality, compliance, and reliability are essential.
We imagine that you have:
A 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…