Consultant (m/f/d) for CSV, CSA & Processes

Your Opportunity – Shaping Digital Solutions in a Regulated Environment

We are experts in digital dialysis solutions and support our customers holistically: from the initial idea to a market-ready product, from end devices to the cloud. In our projects, we take responsibility for all relevant processes – from project and requirements management to engineering and the validation of complex toolchains. We rely on an innovative tech stack, agile teams, and pragmatic, sustainable solutions with a clear focus on project success.

Your Responsibilities – Consulting with Structure and Accountability

• Plan and execute process & tool validations – You are responsible for planning, performing, and evaluating process and software tool validations in a GxP environment (CSV / CSA).
• Analyze and define requirements – You create and analyze requirements for processes and tools across their entire lifecycle, from procurement and commissioning to decommissioning.
• Build and operate test environments – You support the setup and operation of test environments, create test specifications, and execute tests independently.
• Collaborate with stakeholders – You communicate directly with internal and external stakeholders and ensure transparent, effective collaboration.
• Resolve deviations proactively – You analyze deviations, resolve them independently, or initiate appropriate corrective actions.

Your Profile – What You Bring

• Completed technical degree – e.g. in Electrical Engineering, Medical Engineering, Computer Engineering, Mechatronics, Physics, or a comparable field.
• Experience in CSV / CSA – You have practical experience validating processes, tools, and software in regulated environments such as medical devices or pharmaceuticals.
• Software development fundamentals – You understand software development processes and have experience with programming or scripting languages such as C, C++, or Python.
• Embedded systems & integration know-how – Ideally, you bring hands-on experience with embedded systems and hardware-software integration.
• Initial experience in test automation – You are familiar with basic concepts of test automation and related toolchains.
• Knowledge of relevant standards – e.g. IEC 13485, ISO 14971, GAMP.
• Team spirit & communication skills – You enjoy working in interdisciplinary teams, communicate clearly, and work in a structured, goal-oriented manner with strong intercultural competence.
• Excellent language skills – You have very good German and English skills, written and spoken.
• Flexibility & willingness to travel – You work mainly remotely and are willing to travel within Germany.

Interested in growing into the role? If you bring motivation, commitment, and solid software or software testing expertise, we support your development – including training to become a Certified Tester through our in-house sepp.med Academy.

Be You with Us! – Your Benefits at sepp.med

• Projects with purpose – Work on digital solutions that sustainably improve healthcare.
• Agile work & modern technology – Exciting projects, innovative technologies, and true teamwork.
• Flexibility & trust – Remote work, flexible working hours, and an environment that promotes ownership.
• Learning & development – Individual development paths, training, and certifications through the sepp.med Academy.
• Strong team culture – A collegial, supportive team with open and transparent communication.

Ready for your next step? We look forward to getting to know you!

sepp.med stands for innovation and quality

For over 40 years, sepp.med gmbh has been a reliable partner for innovation and quality in software development, working alongside leading companies in various industries. With our deep expertise in safety-critical software development, quality assurance, and comprehensive project management, we are driving the digital innovations of tomorrow.

Our ability to test even the most complex systems securely and efficiently makes us an indispensable partner for our customers. Together, we develop future-proof

solutions that overcome technological challenges and play a key role in ensuring that our customers always remain at the forefront of their industry.