IT Validation Scientist

Copenhagen, Denmark

Are you ready for a unique opportunity to shape the validation/qualification direction for computerized software in AGC Biologics? Do you have a quality mindset and are you eager to contribute your energy and talent in a in a highly engaged team? Then join us as an IT Validation Scientist in Facility & Equipment Validation, in Søborg (Greater Copenhagen)
Your responsibilities in the role
AGC Biologics CPH continues to enjoy great success, and we are expanding with a new multipurpose production facility in CPH to be in use from 2024. With this new production facility and a steadily increasing number of computerized validation/qualification activities – we are going to need strong skilled IT minded validation/qualification experts with expertise for driving validation activities end-2-end for computerized software.

Key responsibilities:

• Responsible for performing computerized qualification test and protocols, compiling data and completing validation reports for implementation of new software.
• Oversight the different validation activities from planning, execution to completion
• Updating and optimizing current procedures when needed, such as PART 11 Data integrity activities
• Report on progress and milestones to stakeholders

The position offers interaction with different stakeholders both from the site in CPH but also from talented colleagues around the global AGC network. You will be introduced to global biopharmaceutical companies and be an active player in their projects.

The department that will be looking forward to have you on board
You will be a part of the newly formed Facility & Equipment validation department, where currently 14 highly qualified team members are waiting for you. We share a fun/relaxed tone while at the same time have high ambitions to deliver best in class validation/qualification activities across the entire organization, to benefit our global biopharmaceutical costumers.

Why we would will like to have you as part of the team
In our new colleague, we are looking for a person with:

• A relevant academic background and at least 5 years of relevant experience with GMP/IT/validation.
• You have experience or interest within pharmaceutical Quality Management, or you have taken part of GxP system validation and wish to grow in
• Experience with PART 11, GAMP 5, Data integrity from a GxP environment, would be seen as a plus.
• Make things happen in a context of high complexity
• Excellent English language skills both verbally and written
• Good team player, open minded and result-orientated.
• Ability to effectively communicate with a broad audience of stakeholders

We will process the applications in the order they arrive. Therefore, please submit your application and CV as soon as possible, When the right candidates are found, the add will close. For any further questions, are you welcome to contact Jeppe Palm Beckmann on Jpbeckmann@agcbio.com Please be aware that we only take applications into consideration that are send via our career page.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.