Process Design Expert (m|f|d)

Stellenbeschreibung:

Job Overview

Miltenyi 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 focus 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.

Job Description

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.

Qualifications

You 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.

What 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
30 days of vacation, discounted ticket to Germany, e‑bike leasing, capital‑forming benefits, company pension plan, disability insurance, canteen, and much more.

Diversity Statement

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.

We welcome you in an inclusive and collaborative environment. Regardless of gender, sexual identity, age, ethnicity, religion, or disability.