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 Long Island City***
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.
