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Job Description
Seeking a skilled IT CSV Engineer with lab equipment validation experience to join a collaborative team in Cork, responsible for validating Lab Systems in QCL Labs and Manufacturing Operations.
Job Description
We are looking for a highly motivated and experienced IT CSV Engineer to join our team in Cork. As a key member of our team, you will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations.
- 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
As a successful IT CSV Engineer, you will have a minimum of 3 years of experience supporting and validating lab equipment, updating documentation, system testing, and troubleshooting. You will also require:
- Experience analysing and challenging s/w to identify gaps
- Knowledge of 21CFR 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 Cognizant:
- We engineer modern businesses to improve everyday life
- We are dedicated to making a lasting impact
- We are one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era
Benefits:
- Performance Bonus