IT Validation Specialist

3 weeks ago

Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time
Transform Healthcare with Your Expertise

Are you passionate about developing your expertise in IT and Automation Validation in a GMP regulated environment? Do you thrive in a dynamic and social atmosphere with a strong focus on IT, automation, and compliance? If so, we invite you to apply for this exciting opportunity to contribute to our diverse and global team.

The Role

We are seeking a highly skilled and proactive individual to join our team as a Validation Partner. As a key member of our team, you will be responsible for leading the implementation of IT and automation solutions on small to large projects. Your expertise will be invaluable in ensuring compliance and validation of our digitalization and automation solutions.

Key Responsibilities
  • Lead the implementation of IT and automation solutions on small to large projects.
  • Act as a validation and compliance advisor for projects and continuous improvement efforts.
  • Oversee or support the development and delivery of complete validation packages.
  • Collaborate with QA, IT, business teams, and vendors to execute computer system validation activities.
  • Participate in inspections and internal audits.
  • Facilitate verification and validation activities, including test execution, documentation review, and approval.
  • Optimize, develop, and implement work processes and strategies for business advantages.
Requirements

We are looking for an ambitious and proactive colleague who can contribute to the team both professionally and personally. To succeed in this role, you should 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 and standards.
  • Strong project management skills and ability to manage complex tasks.
  • Excellent communication skills in both Danish and English, with a proactive, team-oriented mindset.
About the Team

You will be part of a team that secures daily IT and Automation support to four production facilities, consisting of 25+ competent, open-minded, and curious IT and Automation Technicians and Engineers. We deliver on several minor to large projects to these facilities. Your primary work location will be site Gentofte with occasional work in site Hillerød. Working from home is a well-used option in this role.

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