Computer Systems Validation Expert – Spotfire/Statistica/Redshift

The Role: (Summary)

We are seeking an experienced Computer Systems Validation expert to lead validation and testing for Spotfire, Statistica, and Redshift. This is a critical role to ensure that the integration functionality functions as designed and as per regulatory expectations.  You will work with a cross-functional team including QC, QA, infrastructure, and other vendors.

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 leadership
• GDP review of all project documents is in-scope in aspects of good documentation standards - Templates, Completeness, Coherence.

Required Background:

• Bachelor’s Degree in Life Sciences, Information Technology, Engineering, or a related field
• Minimum 5 years of relevant job experience in a regulated (GxP) environment
• 5+ years of job-related experience in Computer System Validation
• Experience with Regulatory standards and deliverables
• Hands-on experience with the Spotfire, Statistica, and Redshift
• Proven track record in CSV with a strong understanding of  CSV/SDLC practices
• Excellent problem-solving, communication, and documentation skills.

Job Types: Full-time, Permanent

Work Location: In person