OT Operations Specialist

AGC Biologics A/S; København; On-site; DKK 900,000 - 1,100,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP environments

OT infrastructure

SCADA

Historian

MES

OPC UA

Modbus

Profinet

Change Controls

CAPAs

CSV validation

OT cybersecurity

APIs data flows

Education

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

Tools

SCADA

Historian

MES

OPC UA

Job description

Location

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.

About the role

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.

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 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.

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

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. Please note that AGC Biologics does not offer relocation assistance. Applicants must already reside in Denmark or the Greater Malmö area in Sweden. 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 cell 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. AGC Biologics is Your Friendly CDMO Expert – dedicated partners with the expertise and commitment to support our customers and teams. We work with some of the world’s most innovative pharmaceutical companies to develop and manufacture their life‑changing drug products. If you’re motivated by meaningful impact and ready to join our journey, we invite you to explore our current opportunities!