We are seeking an IT CSV Engineer to join our team at Cognizant in Cork. This hybrid role comes with a competitive salary and benefits package, including the opportunity to work collaboratively.
Job Summary
The IT CSV Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations. You will provide systems validation and compliance expertise for newly purchased instruments.
Key Responsibilities:
* Manage lab equipment validation projects from software install to business release
* Prioritize CSV activities in line with the project schedule and monitor progress
* Generate computer system validation documentation, e.g., Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report, in accordance with site procedures and GMP guidelines
* Review software release notes
Requirements
To apply for this CSV Engineer role, you will need a minimum of 3 years of experience supporting and validating lab equipment, updating documentation, system testing, and troubleshooting.
* Experience analysing and challenging s/w to identify gaps
* Knowledge of 21 CFR Part 11 requirements, ER/ES and data integrity guidelines
* Excellent oral and written communication skills, with the proven ability to communicate and build relationships cross-functionally
About Us
Cognizant is dedicated to taking care of employees. We offer innovative career tracks and opportunities, education and training, and compensation, benefits, and wellness packages to help you stay healthy and plan for the future.
At Cognizant, we engineer modern businesses to improve everyday life. Our unique, industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses.