IT Validation Specialist
1 month ago
We are seeking a highly skilled IT/OT Validation Partner to join our team at Novo Nordisk. As a key member of our digitalization and automation team, you will play a crucial role in ensuring the validation and compliance of our IT and automation solutions.
About the RoleAs an IT/OT Validation Partner, you will be responsible for leading the implementation of IT and automation solutions on small to large projects. You will also act as a validation and compliance advisor for projects and continuous improvement efforts. Your daily tasks and responsibilities will include:
- 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 (e.g., IT Risk Assessments, URS, VPL/VPR, xVP/R).
- 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.
To succeed in this role, you will need to have a proven track record in most of the following:
- 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 (e.g., FDA, MHRA) 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.
Novo Nordisk is a global healthcare company headquartered in Denmark. For 100 years, we have been driving change to defeat diabetes and other serious chronic diseases. As a result, our treatments today benefit millions of people living with diabetes, obesity, and rare blood and endocrine diseases. We are proud of that.
We are proud of our people too, and we employ more than 60,000 bright and diverse minds in 80 offices worldwide. With us, your bright mind and commitment help us change lives for people worldwide. In exchange, we offer you a seat in a rewarding and purpose-driven culture where your professional and personal development is highly valued.
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