Validation Engineer

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.

• 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.

• 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.