CSA Validation SME/ GXP/ GAMP 5

Company : Katalyst HealthCares & Life Sciences

Location : New York, NY, 10261

Posted Date : 4 November 2025

Job Details

Job Description:

We need: A senior CSA (Computer Software Assurance) SME with GAMP 5, GxP and 21 CFR Part 11 standards. Candidates need to have previous experience in the GxP industry, or a life sciences industry is required as well as technical competency in FDA regulations. They must draft and execute the GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessary. Candidates must have expertise in generating, reviewing, and addressing CAPAs as well as experience with Data Integrity and ALCOA+ is a plus.
The CSA Validation SME is a key stakeholder in the CSA Center of Excellence (COE). The primary function of this role is to ensure the integrity of CSA projects, with an eye to assessing risk and ensuring integrity. Their responsibilities serve as a key conduit between the COE leadership and the protocol author(s) and tester(s). The CSA Validation SME will ensure validation projects meet regulatory and data integrity requirements, and they will confirm validation projects meet R&D/GSC/IT policies.

Responsibilities:

Provide insight and expertise on validation project risk and complexity.
Maintain validation best practices.
Gather project information from system owner(s).
Collaborate with the Business Analyst on a frequent basis.
Maintain compliance with Good Documentation Practices (GDP).
Aid in writing and reviewing reports summarizing system CSA validation execution.
Collect feedback from System Owner(s) on deliverables.
Draft and execute of GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessary.
Draft, review, and execute other validation documents when necessary.

Requirements:

Bachelor's degree in computer science, Information Technology, Chemical Engineering, Biomedical Engineering, or related degree.
7-10+ years of successful, progressive experience with Computer System Validation and Computer Software Assurance.
Aptitude in GAMP 5 and 21 CFR Part 11 standards.
Previous experience in the GxP industry or a life sciences industry is required.
Technical competency in FDA regulations.
Expertise in generating, reviewing, and addressing CAPAs.
Strong written and verbal communication skills.
Strong ability to collaborate with the team.
Ability to work self-directed in the timely completion of project deliverables.
Practical experience with Data Integrity and ALCOA+ is a plus.

Demonstrated Competencies:

Technical Competency - Develop an understanding of business requirements and work to translate the business requirements to the necessary CSV documents and supporting materials.
Time Management - Able to follow strict deadlines, prioritize tasks, and work well under pressure.
Analytical Skills - Identifies, researches, and demonstrates logical reasoning to communicate critical information.
Agility - Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines.
Strong written and verbal communication skills.
Strong ability to communicate with other COE team members.
Strong analytical and problem-solving abilities.
Understands the purpose of CSA, is passionate about customer safety, data integrity, and product quality.
Adept at solution development and project scoping.
Effectively collaborate with peers, cross-functional teams, and departments.
Strong technical background is preferred.