IT CSV Engineer

at  Cognizant

Do you have lab equipment validation experience, and are you seeking a new job in Cork? Cognizant is looking for an IT CSV Engineer, and the hybrid role comes with an attractive salary and benefits package, including the chance to join a collaborative team.
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.

IN YOUR FIRST FEW WEEKS IN THIS VALIDATION ENGINEER ROLE, YOU CAN EXPECT TO:

• Manage lab equipment validation projects from software install to business release
• Priorities 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.

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, TROUBLESHOOTING. YOU WILL ALSO REQUIRE THE FOLLOWING:

• 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.