IT Validation Expert (m/f/d)

As an IT Validation Expert (m/f/d) you play an important role to keep users of our services safe. You support our software engineering teams to ensure their products and services conform with the necessary validation practices. To succeed you perfectly balance the trade offs between structured regulations and modern, agile software development methodologies.

Your Tasks & Responsibilities:

• Validation Strategy Development: Collaborate with software engineering teams to develop and implement validation strategies tailored to their respective products and microservices. Ensuring alignment with internal policies and seamless integration into agile software development cycles.
• Risk Assessment: Conduct risk assessments for our systems and applications to derive validation needs and recommend mitigation strategies.
• Validation Planning: Assist in creating validation plans, protocols, and reports that align with internal Standard Operating Procedures (SOPs).
• Support Product Validations: Ensure execution and documentation of validation activities, including requirements collection, risk assessment, test scripts, results and communicate corrective actions.
• Internal Procedure Development: Create and update internal company procedures and policies that translate regulatory standards into actionable procedures, ensuring conformance with these standards.
• Internal Trainings and Audits: Perform internal trainings and audits to ensure deep understanding and correct implementation of validation practices across software engineering teams, identifying areas for improvement.

Your Skills & Experience:

• Experience in working with standards and deep knowledge of one of the following regulations is a must:
• GAMP5
• ISO13485
• IEC62304
• FDA 21 CFR Part 820
• ISO14971
• IEEE 829
• Experience in the validation of IT systems is a must.
• Previous experience in working in a GDP environment.
• High sense of responsibility, quality awareness and initiative.
• A structured approach and an eye for detail are mandatory.
• Assertiveness and presentation skills are among your strengths.
• Hands-on mentality, ability to work in a team and communication skills are a matter of course for you.
• Very good written and spoken German and English skills round off your profile.
• Optional knowledge/experience authorities in NL.
• Optional knowledge of agile product development.

Your Benefits:

In order to provide our employees with the best possible support for their individual needs whether it's living a healthy life, having enough time for their families, or developing their skills we offer a wide range of different benefits:

• Flexibility: Whether you need to cater to your family's needs or you are simply looking for more flexibility in everyday life, we support you with flexible working hours.
• Remote work: Our offices remain open, but  you are free to work from home when not required in the office.
• Training & Development: In addition to German and English courses, we offer internal and external training and development.
• Plus many more, depending on Location.