Job Description
Cognizant is seeking a skilled IT CSV Engineer to join our team. As a key member of our organization, you will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations.
The successful candidate will have experience analyzing and challenging software to identify gaps, as well as knowledge of 21 CFR Part 11 requirements, ER/ES, and data integrity guidelines.
In this role, you will work closely with cross-functional teams to ensure the successful execution of projects and the delivery of high-quality results.
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Required Skills and Qualifications
Key Responsibilities:
* Manage lab equipment validation projects from software install to business release
* Prioritize CSV activities in line with the project schedule and monitor budgets
* 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
Skills and Qualifications:
* Experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting
* 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
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Benefits
As a valued member of our team, you can expect a competitive salary and benefits package, including:
* Performance bonus
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Why Choose Us?
At Cognizant, we engineer modern businesses to improve everyday life. We're dedicated to making a lasting impact through innovative solutions and exceptional service. Join us in transforming the future of business.