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.