Position : - Computer Systems Validation Expert - Spotfire/Statistical/Redshift

Location : (Onsite)

Duration : Fulltime

Position Summary :

We are urgently seeking an experienced Computer Systems Validation (CSV) Expert to lead validation and testing efforts for Spotfire, Statistica, and Redshift platforms.

This position plays a vital role in ensuring that integrated systems operate as intended and in full compliance with regulatory standards. The CSV Expert will collaborate with cross-functional teams, including Quality Control (QC), Quality Assurance (QA), Infrastructure, and external vendors.

Key Responsibilities :

- Author major validation deliverables in accordance with Moderna's and regulatory standards.

- Review and approve CSV deliverables based on defined project milestones.

- Identify and prioritize system requirements; document them in a Software Requirements Specification (SRS).

- Facilitate communication and drive convergence across multiple interdependent teams.

- Manage stakeholder communication and address inquiries effectively.

Develop and maintain comprehensive validation documentation, including :

a. Validation Plans

b. Test Cases

c. Validation Protocols

d. Validation Reports

- Collaborate with Digital, Business, and QA teams to align testing documentation with system requirements.

- Ensure all documentation adheres to regulatory requirements and internal compliance policies.

- Participate in validation execution, support test case execution, and record results.

- Perform detailed documentation reviews to ensure completeness, accuracy, and compliance.

- Contribute to the continuous improvement of validation/testing methodologies and documentation standards.

- Conduct GDP (Good Documentation Practice) reviews of all lifecycle documents.

- Ensure compliance with documentation standards regarding templates, completeness, and coherence.

Required Qualifications :

- Bachelor's degree in Life Sciences, Information Technology, Engineering, or a related field.

- Minimum of 5 years of relevant experience in a regulated (GxP) environment.

- At least 5 years of hands-on experience in Computer System Validation.

- In-depth knowledge of regulatory standards and compliance deliverables.

Proven experience with the following systems/tools :

a. Spotfire

b. Statistica

c. Amazon Redshift

- Strong understanding of CSV, Software Development Life Cycle (SDLC), and system integration principles.

- Excellent problem-solving skills with strong communication and documentation abilities.