(Senior) Validation Specialist – QMS (m/f/d)

ORGENTEC Diagnostics GmbH is the world's market leader in the development and production of test systems for the diagnostic of infectious and autoimmune diseases. As part of the Sebia Group, headquartered in Lisses/France, ORGENTEC is providing medium-sized laboratories in over 100 countries with high-performance and innovative equipment and test kits. Our company is characterised by constant and sustained growth in an international, future-oriented business. To strengthen our Quality Assurance department, we are looking for (Senior) Validation Specialist (m/w/d) – QMS in full time, no shiftwork

Planning, implementation and documentation of qualifications (IQ / OQ / PQ) for laboratory equipment, production plants and test equipment Compilation and maintenance of qualification and validation relevant documents (such as URS, risk analyses, protocols and reports) Planning, evaluation and monitoring of process and revalidation – practical, with risk assessment and statistical methods Development and validation of test methods, plus determination and evaluation of acceptance criteria and performance parameters Control and coordination of validation projects including roadmap, scheduling and reporting Close cooperation with interfaces such as QC, production, R&D, engineering and supply chain Implementation and moderation of risk assessments (e.g. FMEA) and assessment of changes in validity relevance Audit Readiness and support for internal and external audits (e.g. ISO 13485, IVDR and FDA) Training and support of employees in validation processes and further development of standards and best practices

Complete bachelor studies in engineering, quality management, natural sciences or a comparable subject. A further conclusion, for example a master, is advantageous At least five years of professional experience in the validation context in regulated environments, ideally in in vitro diagnostics or medical technology Knowledge of qualification and validation processes (IQ / OQ / PQ) and relevant regulatory requirements Experience in the creation and maintenance of validating documentation as well as in the handling of risk-based approaches (e.g. FMEA) Structured, independent working with focus on quality; good communication and team skills Liquid knowledge of German and English in word and writing

Unlimited contract in a high-growth company Crisis-proof workplace with attractive salary Flexible working hours, adapted to your life No shiftwork Monthly grant up to €200 for nativity and kindergarten Free parking directly at the company location Individual support and training opportunities Attractive package of health and social benefits (e.g. grant of picture screen work glasses, influenza protection vaccination and employer grant of 30% to private pensions) Daily freshly cooked food from regional ingredients – with food supplement Free drinks: coffee, tea, cocoa and water Exclusive employee discounts at well-known brands Jubilee grants as appreciation for your loyalty