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CSV Auditor Miejsce pracy: Szczecin Your responsibilities Define and lead the CSV roadmap for ERP transformation. Develop and maintain the Master Validation Plan and supporting procedures. Oversee validation activities, documentation, and change control for ERP and related systems. Provide regulatory insight during process design workshops to ensure compliance by design. Lead internal audits, support external inspections, and recommend improvements. Collaborate with global teams and share knowledge on CSV best practices. Our requirements Experience in Computer System Validation within regulated environments. Strong understanding of GxP requirements and standards (FDA, EU Annex 11, ISO). Ability to lead projects, influence stakeholders, and manage documentation. A proactive mindset and willingness to learn and share knowledge. What we offer Attractive office with relax zones located in Szczecin, Poland. A vibrant and international environment with social, diverse, and highly skilled and cooperative colleagues. An attractive Luxmed healthcare package with additional dentistry care. Fresh fruits, delicious and healthy lunches cooked by our canteen. We provide a great social work environment with many optional activities. Good work/life balance. Language courses with qualified teachers. Benefits flexible working time fruits integration events corporate library no dress code coffee / tea leisure zone extra social benefits charity initiatives Join us as a CSV Auditor and play a key role in ensuring quality and compliance for our global ERP transformation. You’ll define and lead the Computer System Validation (CSV) strategy, create the Master Validation Plan, and make sure our systems meet regulatory standards like GAMP 5, ISO 13485, FDA 21 CFR Part 11, and EU Annex 11. This role is highly collaborative - you’ll work closely with IT, quality, and business teams to embed compliance into processes and keep our systems audit-ready. You’ll also be the go-to expert for CSV during audits and inspections. We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results, is by welcoming diverse people into our community. 3Shape Poland Sp. z o.o. 3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000 employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday lifeat3Shape across the globe on LinkedIn. Please add consent for processing personal data:“I agree to process my personal data for current recruitment procedure in accordance with article 6 item 1 lit. "a" of the Regulation of the European Parliament and of the Council (EU) 2016/679 of 27th of April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46 / EC (General Data Protection Regulation).”If you would like that your CV is placed in 3Shape recruitment data base for future recruitment, please add second clause in your CV: “I agree to process my personal data for future recruitment procedures as well”.In accordance with provisions of GDPR please be informed that the data controller in this case is 3Shape Poland Sp. z o. o. with headquarters in Szczecin 70-033, at Zapadła 8d, but your application may be proceeded within the 3Shape Group. Your personal data will be used only for purpose related to the recruitment procedures and will be kept in our database for a period of 12 months. More information about proceeding of your personal data by 3Shape you may find here or contacting local HR Department.Please be informed, in case of interview in our company, that the 3Shape Poland Sp. z o. o. uses closed circuit television (CCTV) images to provide a safe and secure environment for employees and for visitors to the 3Shape Poland Sp. z o. o. business premises as well as to protect the 3Shape Poland Sp. z o. o. property and assets. The CCTV system may be used to investigate security incidents in order to secure evidence, should such incidents occur. All footage gathered is stored no longer than 30 days. The images that are filmed are recorded centrally and held in a secure location.