IT Validation Specialist

Transform healthcare with your expertise as a key player in the development and delivery of digitalization and automation solutions. As our IT/OT Validation Partner, you will be a vital part of a global team that secures daily IT and automation support to four production facilities.

The Role

As a Validation and Compliance Specialist, you will lead the implementation of IT and automation solutions on small to large projects, acting as a validation and compliance advisor for projects and continuous improvement efforts. Your daily tasks and responsibilities will include:

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• Leading the implementation of IT and automation solutions on small to large projects
  
  
• Acting as a validation and compliance advisor for projects and continuous improvement efforts
  
  
• Overseeing or supporting the development and delivery of complete validation packages
  
  
• Collaborating with QA, IT, business teams, and vendors to execute computer system validation activities
  
  
• Participating in inspections and internal audits
  
  
• Facilitating verification and validation activities, including test execution, documentation review, and approval
  
  
• Optimizing, developing, and implementing work processes and strategies for business advantages
  

Qualifications

We are looking for an ambitious and proactive colleague who can contribute to the team both professionally and personally. To succeed in the role, you have a proven track record in most of the following:

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• Relevant educational background or strong Pharma/Life Sciences compliance experience, particularly with validated computer systems
  
  
• Experience with Azure DevOps, software development, and automated/scripted testing
  
  
• Knowledge of pharmaceutical Quality Management and GxP systems
  
  
• Familiarity with global regulatory guidelines and standards like FDA 21CFR Part 11, GAMP, Annex 11, and Data Integrity guidance
  
  
• Strong project management skills and ability to manage complex tasks
  
  
• Excellent communication skills in both Danish and English, with a proactive, team-oriented mindset
  
  

The Team

You will be part of a team that delivers on several minor to large projects to four production facilities, consisting of 25+ competent, openminded and curious IT and Automation Technicians and Engineers. Your primary work location will be site Gentofte with occasionally work in site Hillerød. Working from home is an option in this role.