The opportunity
We are recruiting for a Validation Engineer to work within the Engineering team, based in Vilnius.
How you’ll spend your day
Lead and execute validation efforts for computerized systems to ensure compliance with regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, and other relevant guidelines.
Develop, review, and approve validation documentation such as Validation Plans, Risk Assessments, Requirement Specifications, Test Protocols, and Validation Reports.
Conduct periodic reviews of validated systems to ensure ongoing compliance and revalidate as necessary.
Collaborate with cross-functional teams, including IT, QA, and Operations, to ensure aligned validation strategies and seamless project execution.
Investigate and address discrepancies or anomalies during validation activities.
Stay updated with emerging regulations and best practices in computerized system validation.
Conduct training for relevant stakeholders on CSV principles and best practices.
Support internal and external audits by providing expertise and documentation related to computerized system validations.
