IT/OT Validation Manager, Manufacturing Execution System (MES) Requistion ID: 6654 Location: Copenhagen, Danish Capital Region, DK **IT/OT Validation Manager, Manufacturing Execution System (MES)** Are you motivated to lead the validation of complex IT/OT systems in a global pharmaceutical production environment? Do you have a strong background in validation, compliance, and regulatory standards? If yes, we invite you to apply for this exciting new position as IT/OT Validation Manager in our Global MES Programme. **Your new role** We offer you a super exciting job opportunity in our MES Programme, which is implementing PAS-X and Inmation on our production sites in Denmark and France. PAS-X and Inmation are leading technologies in MES and data integration, ensuring high efficiency and compliance in production. The MES Programme covers the following production processes: Chemical Production, Liquid Sterile, Solid Bulk- and Finished Goods Production. As our central Validation Manager, you will be part of the central MES team and be responsible for the following tasks: + Defining the Validation strategy and approach for deployment of the Central PAS-X- and Inmation Core Solutions. + ​Prepare Validation Documentation related to implementing, operating, and upgrading PAS-X and Inmation systems on production sites. + Ensure compliance with regulatory requirements (e.g., GxP, FDA, EMA). + Execute and review Validation Activities. + Aligning validation processes with stakeholders across production sites and QA functions. + Prepare and review relevant Standard Operating Procedures (SOP´s). + Participate and present Validation Documentation during Inspections/Audits. You will be part of a Team implementing IT/OT in both Denmark and France, but Valby will be the main workplace and only minor travel activities are expected. **Your future team** You’ll be joining a newly established department called Manufacturing IT/OT, which is working globally and anchored in the production organization in Valby. Besides operation of production IT/OT solutions, the team defines and executes the IT/OT roadmap supporting the digital transformation of production in Lundbeck. This is done in close collaboration with our stakeholders in Production Divisions and Global IT. The main elements in our team culture are: + We are enthusiastic and ambitious. + Collaborative and Innovation-based culture. + Inclusive environment that values diversity and equality. + Informal environment with high focus on empowerment and development. **What you bring to the team** + Engineering/ pharmaceutical sciences/Business degree (B.Sc., M.Sc. or similar). + 3-5 years of experience in system validation within a GxP environment. + Strong knowledge of regulatory requirements such as GxP, FDA and EMA. + Proven stakeholder management skills across all levels of the organization. **How your colleagues would describe you** + Structured, detail-oriented and self-driven. + A problem-solver with a “can do”-attitude, motivated by challenges. + Open minded and able to think critically and creatively. + Great communicator (oral and written in English). **Our promise to you** Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being. We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion . **Apply now** Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you! Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience. If you have questions or want to hear more, please feel free to contact Kim Bach Nielsen, Director mobile: +45 3083 3726. Applications will be evaluated on an on-going basis, so do not wait to apply. Learn more about us at www.lundbeck.com ,LinkedIn (https://www.linkedin.com/company/lundbeck/) or Instagram (@h_lundbeck). \#EveryBrainInTheGame **_This job ad is intended for individuals seeking a career opportunity with Lundbeck._** _We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation._ **About Lundbeck** At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real. **About Lundbeck** At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real.