Tandym Tech

Compensation

Full Description

The CSA Validation SME is a key stakeholder within the ELC CSA Center of Excellence (COE). This role ensures the integrity of CSA projects with a strong focus on risk assessment, compliance, and regulatory adherence. Acting as a subject matter expert (SME), the CSA Validation SME serves as a bridge between COE leadership, protocol authors, and testers. The SME will ensure projects meet regulatory, data integrity, and organizational (R&D/GSC/IT) policies while maintaining best practices in validation and documentation. • **Long term contract to hire in Queens*** Responsibilities: • Provide expertise on validation project risk and complexity. • Maintain and promote validation best practices. • Gather project information from system owners and collaborate frequently with Business Analysts. • Ensure compliance with Good Documentation Practices (GDP). • Support the writing and review of reports summarizing CSA validation execution. • Collect feedback from System Owners on deliverables. • Draft, review, and execute validation documentation, including: • GxP Assessment • Risk Assessment (RA) • Validation Plan (VP) • Test Plan (TP) • Validation Summary Report (VSR) • Support the generation, review, and execution of additional validation documents as required. Qualifications: • Bachelor's Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or a related field. • 7-10+ years of progressive experience in Computer System Validation (CSV) and Computer Software Assurance (CSA). • Strong knowledge of GAMP 5 and 21 CFR Part 11 standards. • Previous experience in GxP or life sciences industries. • Technical competency in FDA regulations. • Expertise in generating, reviewing, and resolving CAPAs. • Strong written and verbal communication skills. • Ability to collaborate effectively with cross-functional teams. • Self-directed with strong time management and project delivery skills. • Practical experience with Data Integrity and ALCOA+ principles is a plus. Desired Skills: • Extensive experience in Medical, Pharma, or Regulatory Compliance industries. • Strong CSA expertise; able to serve as SME. • Agile methodology knowledge preferred. • Strong communication, leadership, and collaboration skills. • Ability to manage competing priorities and meet deadlines. • Analytical, problem-solving, and solution-development skills. • Commitment to customer safety, data integrity, and product quality.