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Digital System Validation Engineer
1 week ago
Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. We are seeking an experienced Lab Computer System Validation Engineer to join our team on a long-term contract basis.
In this role, you 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 and support of existing instruments within a collaborative Computerised Instruments team.
We require a strong understanding of 21CFR Part 11 requirements, ER/ES, and data integrity guidelines. Your excellent communication and interpersonal skills will enable you to work effectively with cross-functional teams.
The ideal candidate will have minimum 10 years' experience supporting and validating lab equipment, updating documentation, system testing, and troubleshooting. Strong oral and written communication skills are essential, with proven ability to communicate and build relationships cross-functionally.
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 of software release notes
• Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
Requirements:
• Minimum 10 years' experience supporting and validating lab equipment
• Experience of analyzing and challenging software to identify gaps
• Knowledge of 21CFR Part 11 requirements, ER/ES, and data integrity guidelines
• Strong oral and written communication skills
This is a unique opportunity to utilize your technical expertise in a dynamic environment. If you possess a passion for system validation and compliance, we encourage you to apply for this exciting role.
