About the Role:

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.

What you’ll do

• 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.

What we’re looking for

• 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.

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.

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.

In compliance with the Whistleblower Protection Act, we inform candidates that an internal whistleblowing channel is available within our organization.

About us

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.