Validation (CSA) SME

Company : Katalyst HealthCares & Life Sciences

Location : New York, NY, 10055

Posted Date : 1 November 2025

Job Details

Responsibilities:

Provide subject matter expertise on validation project risk and complexity.
Ensure adherence to validation best practices and compliance standards.
Gather project information and requirements from system stakeholders.
Collaborate frequently with Business Analysts and cross-functional teams.
Maintain compliance with Good Documentation Practices (GDP).
Support authoring and reviewing of validation reports and documentation.
Collect and integrate feedback from system stakeholders on deliverables.
Draft and execute GxP Assessments, Risk Assessments, Validation Plans, Test Plans, and Validation Summary Reports as needed.
Review, draft, and execute additional validation documentation when required.

Requirements:

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).
Solid knowledge of GAMP 5 and 21 CFR Part 11 standards.
Prior experience in GxP or life sciences industries required.
Strong understanding of FDA regulations and compliance requirements.
Proven experience creating, reviewing, and resolving CAPAs.
Ability to work independently while meeting project deadlines.
Practical knowledge of Data Integrity and ALCOA+ principles is a plus.
Technical Competency: Able to translate business requirements into CSV documentation and supporting materials.
Time Management: Manages strict deadlines and competing priorities effectively.
Analytical Skills: Applies logical reasoning to identify, research, and communicate critical information.
Agility: Adapts to shifting priorities and timelines while maintaining high-quality deliverables.
Commitment to Quality: Demonstrates strong understanding of CSA, prioritizing customer safety, data integrity, and product quality.

Must Have:

Extensive experience within medical, pharmaceutical, or regulatory compliance environments.
Strong Computer Software Assurance (CSA) expertise; able to serve as the subject matter expert.
Excellent communication, leadership, and collaboration skills; positive and approachable demeanours.
Agile methodology knowledge/experience strongly preferred.