Computerized System Validation Manager (m|f|d)

Overview

Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering therapies for serious life-threatening diseases, reshaping accessibility for clinical professionals and patients worldwide. We focus on difficult-to-treat hematological cancers using CAR-T and other technologies, and our lead candidate, a tandem CAR T-cell product, is undergoing pivotal clinical trials and prepared for global submission.

Responsibilities

• You execute and oversee validation and qualification activities (including CSV) and ensure compliance with GxP, data integrity standards, and our QMS.
• You review and approve validation documentation such as plans, protocols, reports, and risk assessments to ensure accuracy and regulatory alignment.
• You develop and maintain QA documentation—including SOPs, work instructions, templates, and tools—supporting validation, qualification, and change control.
• You guide and train our teams on QA expectations related to validation, qualification, and change management, fostering strong quality awareness.
• You provide QA review and approval within our change management process, ensuring proper assessment and control of changes impacting validated systems.
• You ensure structured documentation, controlled access, and reliable version management, while contributing to additional QA tasks as needed.

Qualifications

• You hold a university degree or have equivalent professional experience in a relevant field, ideally in biosciences, pharmacy, or engineering.
• You bring experience in validation and qualification within a GxP-regulated environment, preferably in the pharmaceutical or biotechnology industry.
• You have a solid understanding of CSV, GxP, and data integrity principles, and are familiar with EU and FDA regulatory expectations.
• You are experienced in reviewing technical documentation and applying quality standards in a structured and detail-oriented manner.
• You are confident working with digital tools and platforms such as VEEVA (Safety, RIM, Clinical). Experience with Ennov is a plus.
• You communicate clearly and fluently in English (C1) and collaborate effectively across departments.

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 is the bedrock of our creativity

Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. We connect the dots across 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.