Computer System Validation Specialist (Biotech)

TL;DR

Computer System Validation Specialist (Biotech): Managing validation documentation for IT systems in a GxP-regulated environment with an accent on ensuring regulatory compliance and system integrity. Focus on developing Validation Plans, URS, and IQ/OQ/PQ reports to support clinical research operations.

Location: Fully remote, but must be based in Vietnam or Philippines

Company

hirify.global is a science-driven biotech focused CRO providing premium trial management and IT solutions for multi-country clinical trials.

What you will do

• Manage validation activities and documentation, including Validation Plans, URS, IQ/OQ/PQ, and UAT reports.
• Collaborate with IT, QA, and system stakeholders to ensure compliant validation processes.
• Oversee change control, periodic reviews, and software lifecycle documentation.
• Support deviation handling and CAPA management in accordance with quality standards.
• Participate in audits, deliver CSV training, and support regulatory updates.
• Maintain activity tracking and ensure completion of KPIs/KQIs.

Requirements

• Must be based in Vietnam or Philippines.
• Experience in a clinical research or GxP-regulated environment (preferred).
• Strong knowledge of Computer System Validation (CSV) and software lifecycle documentation.
• Good command of English (written and verbal).
• Master’s or Engineering degree (preferred).
• Proficiency in Microsoft Office.

Culture & Benefits

• Competitive salary.
• Full onboarding and training program to support success in the role.
• Long-term growth opportunities and a clear development path.
• Fully remote work arrangement.