Computerized Systems Engineer

Department IT & Automation, Drug Substance Manufacturing, Global Manufacturing & Supply Location Kalundborg, Denmark. Your main base is close to the manufacturing sites. Travel to partner locations in the Copenhagen area may occur on an ad hoc basis but is not a regular work location. Your impact begins here As a Computerized Systems Engineer, you keep the computerized equipment, smart instruments and IT/OT systems behind large-scale drug substance production running reliably and in a validated, GMP-compliant state. Your work supports consistent, stable operations that colleagues in production depend on every day—helping ensure the medicines people living with serious chronic diseases rely on can be made safely and on time. What you'll bring We're looking for a proactive, collaborative colleague who is eager to develop within computerized systems, digital manufacturing and IT/OT support in a GMP-regulated environment. Essential: A B.Sc., M.Sc., AP Degree or similar within IT, Engineering, Automation, Instrumentation, Computer Science or a related technical field. Full professional proficiency in English, written and spoken. An interest in learning GMP requirements and maintaining systems in a validated environment. A structured, solution-oriented approach, ownership of your tasks and genuine enjoyment of working with different stakeholders. Useful, but not essential: Experience from IT, automation, instrumentation, manufacturing support, laboratory systems or technical support functions. Recent graduates with relevant internships, student jobs or project work are also encouraged to apply. Knowledge of manufacturing processes or experience from a regulated industry. Experience with incident and change management, user administration, system maintenance, SOPs, backup and recovery, or supplier coordination. Familiarity with validation, data integrity, IT security, risk assessments, infrastructure or computerized systems lifecycle management. What you'll do You'll help secure reliable, compliant operations across production by maintaining the systems that keep manufacturing moving. In practice, you will: Maintain and support computerized equipment, smart instruments and related IT components to ensure availability, reliability and operational stability. Contribute to ongoing process validation (OPV) and periodic reviews, and manage Operation and Maintenance SOPs through their full lifecycle. Support incident, problem, deviation and change management, and coordinate patching, upgrades, backup, recovery, restore planning and user access in line with quality and validation requirements. Identify IT and computerized equipment risks and complete IT risk assessments covering security, data integrity, infrastructure, coding/configuration, smart instruments and operational support. Safeguard data integrity for electronic data generated, processed, stored or transferred…