Validation Consultant m/f/d

Your Opportunity – Shaping Digital Solutions in a Regulated Environment

We provide comprehensive support to our medtech clients—from the initial idea to a market-ready product, and from the end device to the cloud. In our projects, we manage all relevant processes: requirements management, engineering, and validation of complex toolchains. We rely on an innovative tech stack, agile teams, and pragmatic solutions with a clear focus on project success—and on software that must be truly secure.

Your Responsibilities – Consulting with Structure and Accountability

• Plan process and tool validations – you will be responsible for planning, executing, and evaluating software and process validations in a GxP environment (CSV/CSA) – from start to acceptance.
• Analyze and define requirements – you will develop requirements for processes and tools throughout their entire lifecycle: from procurement and commissioning to decommissioning.
• Set up and operate test environments – you assist in setting up test environments, create test specifications, and conduct tests independently.
• Actively engage stakeholders – you serve as the bridge between technology and business units, ensure transparent communication, and keep all relevant parties in the loop.
• Identify and resolve deviations – you analyze deviations in a structured manner, resolve them independently, or coordinate the resolution – always with an eye toward compliance and pragmatism.

Your Profile – What You Bring

• A technical degree or comparable training — e.g., medical technology, computer engineering, electrical engineering, mechatronics, physics, or a related field.
• Experience in CSV/CSA—you have previously worked on the validation of processes, tools, or software in a regulated environment.
• Fundamentals of software development – you understand software development processes and have experience with programming or scripting languages such as C, C++, or Python.
• Expertise in embedded systems and integration – ideally, you have experience with embedded systems and hardware-software integration.
• Basic experience in test automation – you are familiar with common concepts and tools in test automation.
• Knowledge of relevant standards – e.g., ISO 13485, ISO 14971, GAMP – you understand why these standards exist and how to apply them.
• Strong communication skills & team spirit – you enjoy working in an interdisciplinary environment, communicate clearly in German and English, and demonstrate structured, goal-oriented work.
• Flexibility & Willingness to Travel – You primarily work remotely and are open to nationwide project assignments.

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.