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GxP Computer Systems Validation; CSV) Specialist
Job in
Washington, District of Columbia, 20022, USA
Listed on 2026-09-30
Listing for:
Veritas Search Group
Full Time
position Listed on 2026-09-30
Job specializations:
-
IT/Tech
IT QA Tester / Automation -
Quality Assurance - QA/QC
IT QA Tester / Automation
Job Description & How to Apply Below
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.
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