Process Design Expert

Company DescriptionMiltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages. Job DescriptionAs a Process Design Expert within the Global Supply Chain (GSC) team of Miltenyi Biomedicine, you will play a key role in shaping and optimizing the operational backbone of our clinical and commercial supply chain processes. You lead / co-lead with GSC, the design and implementation of processes for GSC activities, IT tools (including respective CSV), and work aids for clinical trials and commercial processes. You oversee and lead regular QA alignment, while operational QA alignment on DEVs and CEX may be managed by the execution team. The continuous refinement and development of the supporting IT / workflow system and tools is also on your agenda: you identify user requirements and derive specifications, oversee IT development and validation guidelines and selectively support tool administration. To ensure the process design and the implementation, you serve as the process expert, leading the team's efforts in process mapping, optimization, reengineering (CC), revision, documentation (SOPs, RAs), success control (DEVs and CEXs), and tool design, implementation and utilization and provide consultation to other functions as needed. As an integral part of a team of experts, you will collaborate closely with the GSC team lead and fellow process design experts to ensure consistency, scalability, and continuous improvement across all workflows, while managing QA-related interactions including audits, team trainings, and training documentation.  QualificationsYou hold a university degree in engineering, life sciences, economics, informatics, or a related field. You bring experience in process design, and documentation or manual writing as well as related project management -ideally within the pharmaceutical, logistics, or regulated environments. You have a strong analytical mindset and the ability to translate complex requirements into clear, actionable processes. You are a strong communicator who enjoys aligning with diverse stakeholders across functions and geographies and are comfortable with occasional business travel. Fluency in English is required; German is a plus. You are reliable, detail-oriented, and take ownership of your deliverables with a proactive and solution-oriented mindset.  Additional InformationWhat we offer  Working with free and self-determined time management, also mobile working An intercultural environment characterized by diversity and flat hierarchies Freedom to contribute creatively and play an active role in shaping the company Individual further training in our Miltenyi University as the core of the Miltenyi DNA days of vacation, discounted ticket to Germany, (e)-bike leasing, capital-forming benefits, company pension plan, disability insurance, canteen, and much more.  Diversity is the bedrock of our creativity Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots – across various disciplines, linking different perspectives, skills, and abilities. You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability. Become part of our team and focus on pushing the borders of medicine. We look forward to your application If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability.