Risk and Validation Engineer

Risk and Validation Engineer

Permanent contract of employment, hybrid working model from Cracow office – Fabryczna Office Park.(3 days from office, 2 days from home)

JOB SUMMARY:

We are looking for a Process Validation Engineer to join our Operations Engineering team and play a key role in ensuring the quality, compliance, and reliability of our manufacturing processes and equipment within a global medical device environment.

In this role, you will lead and support validation and risk management activities across internal and external operations, helping ensure compliance with FDA and ISO requirements while driving continuous improvement initiatives.
You will be responsible for managing validation programs, maintaining risk management documentation, supporting audits, and collaborating closely with cross-functional teams to ensure high standards across systems, products, and processes.

This position requires a stron...