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Computer Systems Validation (CSV) Engineer

CAIMilano
On-site Full-time

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Experience Level

Experience

Qualifications

Key Responsibilities:The Computer Systems Validation (CSV) Engineer will be responsible for developing and executing validation protocols and test scripts, identifying gaps, and providing consultation for resolution plans. Key documentation responsibilities include writing GxP computer validation documentation and 21 CFR Part 11 related materials such as assessments, plans, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Requirements Traceability Matrices (RTM), and summary reports. Position Requirements:BS in Computer Science, Engineering, or equivalent experience2-7 years of experience in Computer Systems ValidationMinimum of 2 years in a GMP environmentKnowledge of aseptic processesExperience with filling line CSV and automation

About the job

Join Our Team as a CSV Engineer!
CAI, a pioneering professional services firm, has been at the forefront of operational excellence since 1996. With a global workforce nearing 800 professionals, we specialize in delivering vital solutions for the Life Sciences and Mission Critical sectors, ensuring operational readiness in high-stakes environments.
Why CAI?
Our mission is clear: to be the trusted partner for our clients in their pursuit of a better working world and enhanced human experience. Our foundational principles guide us:
· We act with integrity
· We support one another
· We contribute to society
· We strive for a sustainable future
At CAI, we are driven by a commitment to excellence, innovation, and redefining industry standards. We believe that operational readiness is not just a target; it’s a way of life. Join us in pushing boundaries and achieving extraordinary outcomes through relentless dedication and a passion for advancement.
Note: Applicants must be European citizens or hold a valid residence permit for Europe.

About CAI

CAI is a leader in professional services with a rich history of enhancing operational readiness and performance in critical industries. Our elite expertise and rigorous processes empower our clients to navigate complex challenges effectively.

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