IT/OT Validation Partner - Maternity Cover (Denmark, Gentofte)

Jobbeskrivelse
Placering
Gentofte, Denmark

Jobkategori
Digital & IT

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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.

Working at Novo Nordisk
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. That said, opportunities are many in Novo Nordisk.

If you want to learn more about how Novo Nordisk leads visions to real-life solutions that make a real-life impact, go explore on Novo Nordisk TechLife.

Contact
For further information, please contact IT OT Support Manager Martin Ruban Leleur at +45 30775954.

Deadline
24 October 2024

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.