GxP Computer Systems Validation (CSV) Specialist

Veritas Search Group; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Veritas Search Group is seeking an experienced GxP Computer Systems Validation (CSV) Specialist to support validation activities for regulated software applications in a pharmaceutical or biotechnology environment.

This is a hands-on role responsible for reviewing validation packages, assessing testing and documentation, and partnering closely with IT teams to ensure computerized systems meet applicable GxP and regulatory requirements.

Qualifications

• Strong hands-on CSV experience in a regulated environment.
• Solid understanding of GxP requirements and regulatory compliance.
• Experience developing, reviewing, and assessing validation protocols and test scripts.
• Experience working with IT or technology teams.
• Experience validating systems such as Veeva, SAP, LIMS or similar.
• Experience with system integrations is a plus.
• Pharmaceutical/biotech or other regulated-industry experience preferred.

Responsibilities

• Review validation packages, protocols, test scripts, and supporting documentation.
• Independently execute and manage validation activities for projects.
• Write, review, and assess IQ/OQ/PQ and UAT test scripts.
• Partner with IT teams responsible for system implementation, testing, and protocols.
• Support validation of upgrades, new implementations, and integrations.
• Evaluate testing to ensure evidence meets GxP requirements.
• Assist with audits and assessments of third-party technology solutions.

Skills

CSV experience

GxP compliance

Test scripts

IT collaboration

Veeva

SAP

LIMS

Job description

This role requires candidates who are currently authorized to work in the U.S. without sponsorship. This role is remote but you must work EST hours.

Job Summary

We are seeking an experienced GxP Computer Systems Validation (CSV) Specialist to support validation activities for regulated software applications within a pharmaceutical or biotechnology environment. This is a hands-on role responsible for reviewing validation packages, assessing testing and documentation, and partnering closely with IT teams to ensure computerized systems meet applicable GxP and regulatory requirements.

Key Responsibilities

• Review validation packages, protocols, test scripts, and supporting documentation for completeness and compliance.
• Independently execute and manage validation activities for assigned projects.
• Write, review, and assess test scripts, including IQ/OQ/PQ and UAT.
• Partner with IT teams responsible for system implementation, testing, and protocol execution.
• Support validation of system upgrades, new implementations, and integrations.
• Evaluate testing to ensure sufficient evidence exists to meet GxP requirements.
• Assist with audits and assessments of third‑party technology solutions as needed.

Qualifications

• Strong hands‑on Computer Systems Validation (CSV) experience in a regulated environment.
• Solid understanding of GxP requirements and regulatory compliance for computerized systems.
• Experience developing, reviewing, and assessing validation protocols and test scripts.
• Experience working closely with IT or technology teams.
• Experience validating systems such as Veeva, SAP, LIMS, or similar enterprise applications preferred.
• Experience with system integrations and integration validation is a plus.
• Pharmaceutical, biotechnology, life sciences, or other regulated‑industry experience preferred.