IT/OT Validation Partner

Would you like to further develop your expertise with IT and Automation Validation in a GMP regulated area? Do you enjoy working in an open, dynamic and social atmosphere with a strong focus on IT, automation and compliance? If so, apply now and become a part of a diverse, global team, and contribute to transforming healthcare with your expertise. Join us and make a difference 

The Position 

Our projects lie within digitalization and automation solutions, and we need a person to pave the way for all our projects when it comes to validation and compliance. You will be a sparring partner and consultant on smaller projects and a package lead within validation on larger projects. The role will be a maternity cover. 
 
Your daily tasks and responsibilities will be to: 

Lead the implementation of IT and automation solutions on small to large projects. 

Act as validation and compliance advisor for projects and continuous improvement efforts. 

Oversee or support the development and delivery of complete validation packages (e.g., IT Risk Assessments, URS, VPL/VPR, xVP/R). 

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. 

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: 

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. 

The team 
You will be part of a team that secures daily IT and Automation support to four production facilities, consisting of 25+ competent, openminded and curious IT and Automation Technicians and Engineers in Gentofte and 15+ in Hillerød. We deliver on several minor to large projects to these facilities. On the organizational level the team belongs to DDIT API – M4. Your primary work location will be site Gentofte with occasionally work in site Hillerød. Working from home is a well-used option in this role.