IT Validation Specialist (GxP/CSV)

Location: Hybrid, Somerset, New Jersey, United States

Base pay: $68,045–$89,308 USD per year; performance-based bonus and/or equity may be available for eligible roles.

Company

hirify.global is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and NK cell-based therapies.

What you will do

• Execute and support Computer System Validation and Computer Software Assurance activities for GxP-regulated systems.
• Author and maintain validation plans, requirements, risk assessments, test scripts, traceability matrices, and validation summary reports.
• Perform risk-based assessments to define validation scope, testing requirements, and compliance impact.
• Coordinate validation testing, document results, and resolve testing issues and deviations.
• Manage validation documentation and testing activities in VLMS, EDMS, and QMS systems.
• Support change controls, CAPAs, periodic reviews, system-owner guidance, and internal or regulatory audits.

Requirements

• Bachelor’s degree in Life Science, IT, Engineering, or a related field.
• 1–3 years of hands-on Computer System Validation experience in the biotechnology or pharmaceutical industry.
• Experience with validation projects, deliverables, testing activities, and risk-based CSV/CSA methodologies.
• Knowledge of GxP regulations and standards, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements.
• Experience with automated Validation Lifecycle Management Systems and familiarity with QMS and EDMS platforms.
• Applicants must be authorized to work in the United States; employment eligibility is verified through Form I-9 and E-Verify.

Nice to have

• Experience with Computer Software Assurance and validation of AI or use of AI in validation activities.
• Experience with ValGenesis and Veeva Quality Vault.
• Knowledge of systems supporting quality, IT, learning management, laboratories, facilities, equipment, or manufacturing.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance.
• 401(k) retirement plan with a company match fully vested on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal and sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, commuter benefits, family care resources, and well-being programs.