System Validation & Laboratory IT Specialist (m/f/d)

The Institute of Medical Diagnostics (IMD Berlin) is more than just a laboratory – we are an accredited center of competence in which specialist doctors from the fields of laboratory medicine, microbiology, virology, human genetics, endocrinology and diabetics combine their knowledge. Our mission is to support established doctoral practices in Berlin and Brandenburg with first-class diagnostics, precise advice and reliable care. To achieve this, we need powerful digital systems that optimally support our diagnostic processes. Design the future of our laboratory IT. With the introduction of a new laboratory information system (LIS), we are faced with a pioneering transformation project. We are looking for an experienced personality that not only accompanies system validation, but also contributes significantly to establishing modern standards for compliance, data integrity and digital laboratory processes. In this key role you connect quality, IT and laboratory operation. You ensure that our systems meet regulatory requirements, risk management and innovation can be safely implemented.

This will lead you in the LIS project You are responsible for the computer-assisted system validation of our new laboratory information system. You develop risk-based validation and test strategies according to GAMP® 5. You create and control the necessary validation documentation and ensure a comprehensible implementation. You coordinate test activities, evaluate interfaces and accompany cooperation with suppliers. You ensure data integrity, compliance and compliance with regulatory requirements. How to make this in the long term You establish a sustainable approach to the validation of computerised systems in the company. You advise specialist areas, IT and quality management in validation and compliance topics. You support audits and inspections as a competent respondent. You develop standards, templates and best practices and ensure that systems remain validated throughout their life cycle.

Complete study of a scientific, technical or IT-related subject or a comparable qualification. Multiannual experience in Computerized System Validation (CSV) Experience with laboratory, quality management or laboratory information systems GAMP® 5, GxP, Data Integrity, Risk Management and Change Control/CAPA Structured operation and communication strength Very good knowledge of German and English This is a plus Experience in the introduction or migration of an LIS Knowledge of regulatory requirements of FDA, EMA and EU-GMP Experience with CSA, Cloud/SaaS solutions and supplier management Experience with the validation of interfaces and automated laboratory processes Auditor or Lead Auditor Experience

A safe workplace in a recognised accredited laboratory An occupational retirement provision – because we also think of tomorrow A structured incorporation – we leave no one alone 13. Monthly salary and holiday allowance – as a recognition for your services Working hours with time recording – because leisure is not a bonus, but important Massages – Your health is our heart Service wheel leasing – if you prefer to stample instead of jam Free drinks and fruits – small energy booster included Grant to the company ticket – bus and train instead of parking stress Beneficiary laboratory tests for our employees – your health increase with us An open, supportive team – our team counts together Discounts about the Corporate Benefits Portal – for the small extras in everyday life Diversity, equal opportunities and mutual respect are living values at IMD Berlin. We therefore welcome applications of people regardless of gender, nationality, ethnic or social origin, religion or belief, disability, age, sexual orientation and identity. Your qualifications, your personality and your motivation are crucial to us.

Sounds like your next job? We look forward to your application!

!