Senior IT Validation Scientist

<p><b>Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.</b></p><p></p><p><b>Senior IT Validation Scientist</b></p><p><br/><b>Are you ready for a unique opportunity to shape the <span>validation/qualification</span> 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 Senior IT Validation Scientist in Facility &amp; Equipment Validation, in Søborg(Greater Copenhagen)</b></p><p><b>Your responsibilities in the role</b></p><p>AGC Biologics CPH continues to enjoy great success, and we are expanding our portfolio of interesting project in our new state of the art multipurpose production facility. With this new production facility and a steadily increasing number of computerized <span>validation/qualification</span> activities – we are going to need strong skilled IT minded <span>validation/qualification</span> experts with expertise for driving validation activities end-2-end for computerized software.</p><p>Key responsibilities:</p><ul><li>Responsible for performing computerized qualification test and protocols, compiling data and completing validation reports for implementation of new software.</li><li>Oversight the different validation activities from planning, execution to completion</li><li>Updating and optimizing current procedures when needed, such as PART 11 Data integrity activitites</li><li>Report on progress and milestones to stakeholders</li></ul><p>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.</p><p><b>The department that will be looking forward to have you on board</b></p><p>You will be a part of Facility &amp; 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 <span>validation/qualification</span> activities across the entire organization, to benefit our global biopharmaceutical costumers.</p><p><b>Why we would will like to have you as part of the team</b></p><p>In our new colleague, we are looking for a person with:</p><ul><li>A relevant academic background and at least 5 years of relevant experience with GMP/IT/validation.</li><li>You have experience or interest within pharmaceutical Quality Management, or you have taken part of GxP system validation and wish to grow in the role</li><li>Experience with PART 11, GAMP 5, Data integrity from a GxP environment, would be seen as a plus.</li><li>Make things happen in a context of high complexity</li><li>Good team player, open minded and result-orientated.</li><li>Ability to effectively communicate with a broad audience of stakeholders</li></ul><p></p><p>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 <a href="mailto:Jpbeckmann@agcbio.com" rel="noopener noreferrer" target="_blank"><span>Jpbeckmann@agcbio.com</span></a> Please be aware that we only take applications into consideration that are send via our career page.</p><p></p><p><b>AGC Biologics</b></p><p>AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our promise to deliver a reliable and compliant drug substance supply.</p><p>AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout the company interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time.</p><p></p><p></p><p><b>Our culture at AGC Biologics