What does this role involve?

It involves managing end-to-end validation activities, including inventory, assessments, remediation, and final disposition. The role also supports system transition activities.

What experience and skills are required?

The listing requires 7–10+ years of experience in CSV/CSA, infrastructure, and business systems validation. It also calls for GxP systems experience, risk-based validation expertise, and cloud-related experience.

What documentation experience is required?

Experience includes preparing validation documentation such as Validation Plans, Test Protocols, Traceability Matrix, and Validation Reports. The role also reviews test scripts, Design Specifications, Test Plans, and Test Procedures.

Sr. CSVCSAValidation Engineer

External job listingat Vyzeinc

Vyzeinc seeks a Sr. CSVCSAValidation Engineer with CSV/CSA validation experience, GxP systems expertise, and risk-based validation skills.

External source - not verified6 weeks agoOpen until: Nov 5, 2026

Salary

Not provided

Location

Raritan, United States

Employment type

Contract

Workplace

Not provided

Sr. CSVCSAValidation Engineer

Raritan, United States

Job description

About the role

Vyzeinc is seeking a Sr. CSVCSAValidation Engineer to support GxP computerized systems and infrastructure and business systems validation.

Responsibilities

Manage end-to-end validation activities, including inventory, assessments, remediation, and final disposition.
Support business separation, acquisition, divestiture, and system transition activities.
Provide validation guidance, timely reviews, risk escalation, and management support.
Lead and advise validation resources, and manage multiple projects and changes with distributed or remote teams.

Requirements

7–10+ years of experience in CSV/CSA, infrastructure, and business systems validation.
Strong experience supporting GxP computerized systems and knowledge of FDA/global regulated environments and GxP standards.
Expertise in risk-based validation methodologies and experience with SaaS/PaaS, cloud applications, infrastructure, and cloud concepts.
Strong validation documentation experience, including URS/Requirements, Validation Plans, Test Protocols, Traceability Matrix, Test Summary Reports, Validation Reports, SOPs/WIs.
Experience reviewing UAT/system test scripts, Design Specifications, Test Plans, and Test Procedures, along with QA methodology and documentation review and approval.
Strong communication, leadership, teamwork, and independent working skills.

Key facts

Requires 7–10+ years of experience in CSV/CSA, infrastructure, and business systems validation.
The role supports GxP computerized systems.
Responsibilities include end-to-end validation activities and system transition support.
Experience with SaaS/PaaS, cloud applications, infrastructure, and cloud concepts is required.

Frequently asked questions

What does this role involve?
It involves managing end-to-end validation activities, including inventory, assessments, remediation, and final disposition. The role also supports system transition activities.
What experience and skills are required?
The listing requires 7–10+ years of experience in CSV/CSA, infrastructure, and business systems validation. It also calls for GxP systems experience, risk-based validation expertise, and cloud-related experience.
What documentation experience is required?
Experience includes preparing validation documentation such as Validation Plans, Test Protocols, Traceability Matrix, and Validation Reports. The role also reviews test scripts, Design Specifications, Test Plans, and Test Procedures.