Computer Systems Validation Expert

Key Responsibilities of the Position:
Author major validation deliverables in alignment with Moderna and regulatory standards.Review and approve CSV deliverables based on identified project deliverables as per defined project phase.To identify and prioritize the system requirements, which can be documented in a software requirements specification.Communicate interdependencies across multiple teams within own area, drive convergence across these teams to ensure smooth functioning of the teams.Manage stakeholder and prepare communications to stakeholders and respond to stakeholder enquiries.Develop and maintain detailed validation and testing documentation, including validation plans, test cases, validation protocols, and reports.Collaborate with Digital, business, and Quality Assurance teams to understand system requirements and ensure appropriate coverage in testing documentation.Ensure all documentation complies with regulatory standards and internal policies.Participate in validation and testing activities, providing support in the execution of test cases and recording results.Conduct thorough reviews of documentation to identify gaps and ensure accuracy and completeness.Assist in the continuous improvement of validation and testing processes and documentation practices.Review project and system life cycle documents against quality requirements with regards to good documentation practice (GDP) under the leadershipGDP review of all project documents is in-scope in aspects of good documentation standards - Templates, Completeness, Coherence.

Required Background:
Bachelors Degree in Life Sciences, Information Technology, Engineering, or a related fieldMinimum 5 years of relevant job experience in a regulated (GxP) environment5+ years of job-related experience in Computer System ValidationExperience with Regulatory standards and deliverablesHands-on experience with the Spotfire, Statistica, and RedshiftProven track record in CSV with a strong understanding of CSV/SDLC practicesExcellent problem-solving, communication, and documentation skills.