Note: The job is a remote job and is open to candidates in USA. MDAEdge is seeking a Computer System Validation Engineer specializing in Medical Device Equipment & Regulations. The role involves full lifecycle validation of computerized systems in compliance with GxP regulations, including documentation, risk assessments, and collaboration with stakeholders.
Responsibilities
- 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
Skills
- Strong understanding of Good Manufacturing Practice (GxP) regulations and their application in computerized systems
- Knowledge of relevant regulations like FDA 21 CFR Part 11 and International Standards (e.g., EU Annex 11, ICH Q7, and GAMP 5)
- Hands-on experience with the full lifecycle validation of computerized systems, ensuring compliance from system design to retirement
- Capability of developing and executing validation strategies and plans based on industry standards like GAMP 5
- Ability to perform risk assessments to identify potential risks and assess the impact of system changes
- Proficient in test planning and strategy, including the creation and execution of test protocols and scripts such as IQ, OQ, and PQ
- Experience in defect tracking and preparing comprehensive validation reports with clear traceability
- Strong organizational skills to manage and prioritize tasks in a regulated environment
- Familiarity with change control procedures to assess the impact of system changes and prepare or review relevant documentation
- Good understanding of the software development life cycle (SDLC) and system architecture
- Data validation expertise to ensure the integrity and reliability of system data
- Familiarity with CSV tools and validation management software (e.g., Veeva Vault QMS, MasterControl, Trackwise)
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