Computer System Validation Engineer - Medical Device Equipment & Regulations

Job Summary:

• Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.
• Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.
• Compliance Analysis, Validation Planning, Risk Assessments
• Test planning and strategy
• creation and execution of test protocols, scripts and reports.
• Validation Summary Reports, traceability analysis.
• Defect Logging and Tracking till closure.

• Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices.
• Author and update documentation to support ongoing CSV compliance.
• Prepare or review all levels of validation documents including:
• Validation (Strategy) Plans, User Requirement Specifications
• Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs
• Qualification Documents and Test Specifications (IQ, OQ, PQ)
• Traceability Matrices, Risk Analysis
• Validation Reports, Change Controls/ Events / Deviations etc
• Assess the impact of changes proposed to computerized systems and the level of change required.
• Provide validation strategy to the introduction of computerized systems.
• Collaborate with the key stakeholders (Information Systems, Software assurance, business users and suppliers etc) and management on all related matters on a regular basis.

• GxP and Regulatory Knowledge: You should have a strong understanding of Good Manufacturing Practice (GxP) regulations and their application in computerized systems, as well as knowledge of relevant regulations like FDA 21 CFR Part 11 and International Standards (e.g., EU Annex 11, ICH Q7, and GAMP 5).
• Computer System Validation (CSV): You must have hands-on experience with the full lifecycle validation of computerized systems, ensuring compliance from system design to retirement. You should also be capable of developing and executing validation strategies and plans based on industry standards like GAMP 5.
• Risk Assessment: You need to be able to perform risk assessments to identify potential risks and assess the impact of system changes, ensuring the right level of validation is applied.
• Testing & Documentation: You should be proficient in test planning and strategy, including the creation and execution of test protocols and scripts such as IQ, OQ, and PQ. Additionally, you must have experience in defect tracking and preparing comprehensive validation reports with clear traceability.
• Project Management: Strong organizational skills are essential to manage and prioritize tasks in a regulated environment, while also collaborating effectively with cross-functional teams and managing stakeholder expectations.
• Change Control Management: You must be familiar with change control procedures to assess the impact of system changes and prepare or review relevant documentation, including deviations and changes to system processes.
• Technical Knowledge: A good understanding of the software development life cycle (SDLC) and system architecture is necessary, along with data validation expertise to ensure the integrity and reliability of system data.
• Software Tools: Familiarity with CSV tools and validation management software (e.g., Veeva Vault QMS, MasterControl, Trackwise) is important for efficient document management and validation tracking.