• Support compliance activities such as preparing/reviewing validation documentation for identified systems with input from user’s group, QA and IT.
• Documentation writing that would include, but not limited to: Validation Plans, User Requirements, Functional Requirements, Design Specifications, Risk Assessments,IQ/OQ/PQ, UAT, Traceability Matrix, Validation Summary Reports.
• Meet with users/project leaders to determine the intended use of the system, define business processes, and define risk scenarios. Evaluate the system's landscape, architecture, software, and hardware configuration, configurations and user roles.
• Maintain effective computer change control and handle deviation reporting when unexpected events are found during execution of test scripts.
• Bachelors’ degree in Computer Science or some related scientific discipline.
• Experience in Computer Systems Validation and System Development Life Cycle methodology in a pharmaceutical or other FDA regulated industry.
• Strong knowledge of laboratory systems is preferred.