OT Operations Specialist

AGC Biologics; København; On-site; DKK 700,000 - 980,000; Full time

Job summary

AGC Biologics in Søborg, Denmark, seeks an OT Operations Specialist to maintain and improve the OT landscape in a GMP manufacturing setting. You will ensure reliable systems and collaborate with Automation, Engineering, Manufacturing, Quality, and IT teams to enable digitalization.

The role emphasizes Change Controls, CAPAs, CSV activities, and continuous improvement across MES, SCADA, Historian, and ERP interfaces.

Qualifications

• Bachelor degree in Engineering, IT, Automation or similar field.
• 5+ years of OT, Manufacturing IT, Automation or Life Sciences experience.
• Strong GMP-regulated environment knowledge.
• Experience with Change Controls, Deviations, CAPAs and validation.
• Experience with OT infrastructure, servers, virtualization and industrial networks.
• Experience with manufacturing systems like SCADA, Historian, MES.

Responsibilities

• Support and maintain OT infrastructure and GMP-regulated systems.
• Manage OT servers, virtualization platforms, industrial networks, and integrations.
• Troubleshoot OT issues across manufacturing environments.
• Collaborate with Automation, Engineering, Manufacturing, Quality and IT teams.

Skills

OT/Automation expertise

GMP knowledge

SCADA/Historian/MES experience

Stakeholder management

Problem solving

Education

Bachelor’s degree in Engineering/IT/Automation

Tools

SCADA

Historian

MES

OPC UA/Modbus/Profinet

Job description

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:

• 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.

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 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 15 November 2026.

If you have any questions about the position, please contact Jimmy Jespersen, Director of IT, at [e-mail]

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.

We look forward to receiving your application!

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 life‑changing advanced biologics for some of the world’s 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.