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Description
We are looking for a detail-oriented and experienced CSV Engineer to join our team. The CSV Engineer will be responsible for ensuring that computer systems and software used in regulated environments meet compliance requirements and operate according to user specifications. The ideal candidate will have a strong background in CSV, an understanding of industry regulations, and the ability to manage validation projects from start to finish.
Key Responsibilities:
- Write and execute validation documentation including User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and Requirement Traceability Matrices (RTM).
- Review and approve vendor and third-party custom software documentation to ensure it meets internal validation requirements.
- Ensure compliance with GAMP 5 guidelines for custom designed software system including complete functional testing and source code review.
- Co-ordinate with cross-functional teams (e.g., IT, quality assurance, engineering) to ensure proper validation processes are followed.
- Provide on-going support for system changes, including software design change and re-configuration.
- Perform data integrity assessments and ensure proper data handling practices are followed for bespoke system.
- Communicate project status, issues, and risks to clients and internal teams.
- Provide technical expertise and guidance to clients and project teams throughout the validation process.
- Stay updated on industry trends, regulatory changes, and technological advancements to ensure compliance and improve validation practices.
- Work closely with clients to understand their needs and requirements, providing expert advice and solutions.
- Collaborate with cross-functional teams, including IT, Quality Assurance, and regulatory compliance, to achieve project goals.
