OT Systems Engineer – shaping the future of digital manufacturing
Copenhagen - Denmark
Job Summary
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 Systems Engineer 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 an OT Systems Engineer 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 Bachelors 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.
It is an advantage if you have experience with:
MES platforms and manufacturing system integrations.
APIs and data flows between systems.
Industrial communication protocols such as OPC UA Modbus or Profinet.
OT cybersecurity frameworks and best practices.
Supporting FDA EMA or other regulatory inspections.
Why join AGC Biologics
At AGC Biologics you will have the opportunity to shape the future OT landscape and digital manufacturing strategy while working in a highly regulated and technologically advanced production environment.
You will collaborate with talented colleagues across a global organization where innovation knowledge sharing and continuous improvement are part of everyday life. Your work will directly contribute to ensuring reliable manufacturing processes that help bring important biologic therapies to patients worldwide.
Join our team
We are eager to welcome a new colleague as soon as possible. Please submit your application no later than 1 September 2026.
If you have any questions about the position please contact IT/OT Operations & Service Delivery Manager Henrik Jacobsen at .
Please apply exclusively through our recruitment system. Applications submitted through other channels will not be considered.
To support an inclusive and unbiased recruitment process please do not include a photo in your CV. At AGC Biologics we are committed to fair hiring practices and value diversity and inclusion throughout our recruitment process.
Who We Are
AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site we develop and manufacture lifechanging advanced biologics for some of the worlds most innovative pharmaceutical companies. Together with our team members across Europe the U.S. and Japan we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells therapies. Across our global network we are united by one mission: To work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.
Required Experience:
IC