Job Description
We are seeking an experienced IT CSV Engineer to support critical validation activities across our IT systems.
About the Role
The successful candidate will be responsible for developing and implementing CSV protocols, conducting risk assessments, executing validation activities in compliance with regulatory requirements, and ensuring all documentation is complete and accurate.
* Main Responsibilities:
* Develop and implement CSV protocols including VMP, IQ, OQ, and PQ.
* Conduct risk assessments to identify validation gaps and define mitigation strategies.
* Execute validation activities in compliance with FDA, EMA, and GxP regulations.
* Ensure all documentation is complete, accurate, and audit-ready.
Requirements
To be successful in this role, you will need:
* A degree in Computer Science, IT, Life Sciences, or a related field.
* 3–5 years of experience in computer system validation within pharma, biotech, or life sciences.
* Strong knowledge of GxP regulations (FDA 21 CFR Part 11, EMA, ICH Q7).
* Solid understanding of validation lifecycle processes (change control, deviations, CAPA).
* Excellent documentation and communication skills with a sharp eye for detail.
What We Offer
We offer a fast-paced, regulated environment where you can make a real impact. As a valued member of our team, you will have the opportunity to work collaboratively with IT, QA, and Regulatory Affairs teams to ensure successful validation outcomes.
Our ideal candidate is a skilled professional who is passionate about ensuring compliance in GxP-regulated environments. If you have a strong desire to learn and grow, we encourage you to apply for this exciting opportunity.