We are seeking a highly skilled Computer System Validation (CSV) Engineer to support our pharmaceutical client with an uplift in work.
This is a contract role that offers an opportunity to contribute to critical CSV activities within a regulated, GxP-compliant environment.
Key Responsibilities :
- Lead and execute Computer System Validation (CSV) activities, ensuring that all computerized systems comply with industry regulations (GxP) and meet operational requirements.
- Author and execute validation documents such as Validation Plans , Test Plans , Test Scripts , and Validation Summary Reports .
- Perform system risk assessments to evaluate GxP applicability, determine the scope of validation, and identify potential risks associated with computerized systems.
- Manage and track discrepancies and deviations during test execution and ensure timely resolution.
- Provide validation support for system changes through Change Control , conducting impact assessments, determining appropriate testing requirements, and documenting change qualifications.
- Support the periodic review of validated systems to ensure ongoing compliance with regulatory and operational standards.
- Assist in the administration of ValGenesis or similar electronic systems used for validation lifecycle management.
- Train and support end users on the use of validation systems (e.g., ValGenesis), ensuring compliance with procedures and efficient system usage.
Key Qualifications :
- Proven experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.
- Strong understanding of GxP regulations (e.g., GMP, GCP) and risk-based validation methodologies .
- Expertise in developing and executing validation documentation, including protocols, test scripts, and summary reports.
- Hands-on experience with computerized systems lifecycle management, particularly in validated environments.
- Proficiency with validation management systems like ValGenesis is highly desirable.
- Excellent problem-solving and analytical skills, with attention to detail in managing validation processes.
- Strong communication skills with the ability to collaborate across multidisciplinary teams.
If you're an experienced CSV Engineer looking for an exciting contract role where you can make an immediate impact, we want to hear from you!
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