**IT CSV Engineer Role Overview**
This role involves working on the validation of lab systems in a collaborative team environment. The IT CSV Engineer will be responsible for ensuring compliance with regulatory requirements, such as 21CFR Part 11 and GAMP5.
The successful candidate will have a minimum of 3 years of experience in supporting and validating lab equipment, updating documentation, and system testing. They will also require excellent communication skills to work effectively with cross-functional teams.
Key Responsibilities:
* Manage lab equipment validation projects from software install to business release
* Prioritize CSV activities in line with project schedules and monitor budgets
* Generate computer system validation documentation, including design specs, configuration specs, testing, security plans, and test summary reports
* Review software release notes
Requirements:
* Minimum of 3 years of experience in supporting and validating lab equipment, updating documentation, and system testing
* Excellent oral and written communication skills to build relationships cross-functionally
* Experience analyzing and challenging software to identify gaps
* Knowledge of 21CFR Part 11 requirements, ER/ES, and data integrity guidelines
Benefits:**
The company offers a range of benefits to support employees' career development, health, and well-being. These include opportunities for education and training, performance bonuses, and comprehensive compensation packages.