Commercialization & 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 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.