GMP OT Systems Engineer – Digital Manufacturing

AGC Biologics; København; On-site; DKK 700,000 - 900,000; Full time

Job summary

AGC Biologics seeks an OT Operations Specialist to maintain and improve our GMP-regulated OT landscape. You will work at the intersection of technology, manufacturing, and quality, ensuring reliable systems and compliance across automation, IT, and manufacturing teams.

With a strong background in OT, MES/SCADA, and validation activities, you will drive continuous improvements, support audits, and contribute to digitalization initiatives in a highly regulated production environment.

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.

Responsibilities

• 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 with Automation, Engineering, Manufacturing, Quality, and IT teams to ensure reliable operations.
• Contribute to CSV activities including IQ/OQ documentation and execution.
• Support integration between manufacturing systems and business systems.
• Participate in digitalization initiatives involving MES, Historian, SCADA, ERP, and related platforms.
• Support OT cybersecurity initiatives and lifecycle management of systems.

Skills

OT landscape

GMP compliance

Change Controls

CAPAs

CSV validation

OPC UA

Modbus/Profinet

SCADA

Historians

APIs & data flows

Stakeholder management

Education

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

Tools

SCADA

Historians

MES

virtualization

OPC UA

Job description

AGC Biologics seeks an OT Operations Specialist to maintain and improve our GMP-regulated OT landscape. You will work at the intersection of technology, manufacturing, and quality, ensuring reliable systems and compliance across automation, IT, and manufacturing teams.

With a strong background in OT, MES/SCADA, and validation activities, you will drive continuous improvements, support audits, and contribute to digitalization initiatives in a highly regulated production environment.