Location
Kalundborg

Do you have a strong understanding of IT infrastructure, compliance, and automation systems?

GMP Consulting Group is looking for an experienced IT Responsible to support a high-priority Water & Steam project in API production. This role is key to ensuring FDA compliance and operational readiness for a fast-track product introduction to the US market. 
You will act as the bridge between automation, IT, and compliance, ensuring that systems are specified, configured, and handed over according to regulatory and operational requirements.

Key Responsibilities

As IT Responsible, you will work closely with system owners, automation engineers, and QA to manage all IT-related aspects of the Siemens PLC-based systems being implemented. Your main tasks will include: 

  • Participating in the preparation and approval of System Specifications and related Workshop Sessions (WS).
  • Defining and settling IT requirements for Siemens PLC systems. 
  • Ensuring backup and recovery strategies are aligned – including Veritas for servers and Octoplant for PLCs.
  • Creating and managing entries in ServiceNow.
  • Supporting ITRA (IT Risk Assessment) activities and associated documentation (IRM).
  • Defining user access levels and role-based access models.
  • Participating in discussions regarding Group Policy Objects (GPOs) and contributing to IT/OT alignment.
  • Defining and managing service accounts in PIMs (Privileged Identity Management systems).
  • Contributing to O&M manual preparation and documentation packages.
  • Preparing and updating handover lists to Operational teams.
  • Identifying SLA and support needs post-handover.

Qualifications and Experience

We are seeking candidates with:

  • Solid experience in IT infrastructure and automation in regulated environments.
  • Familiarity with Siemens PLC systems and associated system documentation.
  • Experience with backup/recovery solutions like Veritas and configuration tools like Octoplant.
  • Strong understanding of IT Risk Assessments, ServiceNow workflows, and user access control principles.
  • Working knowledge of GPOs, PIMs, and IT/OT architecture.
  • Experience preparing O&M manuals, handover packages, and managing lifecycle documentation.
  • Fluent in English – Danish is an advantage.

Personal Skills

  • Structured, analytical, and compliance-oriented.
  • Skilled communicator across technical and stakeholder levels.
  • A proactive mindset with the ability to drive alignment across functions.
  • Detail-focused and reliable under pressure.

Details

  • Hours: Full-time (37 hours per week).
  • Location: Kalundborg.
  • Start Date: Q2.

About Us

GMP Consulting Group is a professional consultancy firm advising and supporting stakeholders across the Life Science industry - from public institutions to private enterprises, from subcontractors to parhamaceutical and medical device companies.
We are a team of +50 skilled consultants, who are committed to delivering the highest quality advice within the Life Science sector. We achieve this through integrity, professionalism, and a human-centered approach.

How to Apply

If this exciting opportunity matches your profile, please send us your CV and a motivated application to: career@gmp-cgroup.com or call our office manager Moèsha Williams at +45 3112 5808. We look forward to hearing from you!