GxP IT Validation Analyst for Biotech Systems (CSV/CSA)

BioSpace; New Jersey; On-site; USD 68,000 - 89,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off and holidays

Job summary

Legend Biotech in Somerset, NJ seeks an IT Validation Analyst to support validation activities for GxP-regulated systems. You will work with IT, QA, and vendors to ensure continued compliance across the system lifecycle.

The role requires creating validation deliverables (plans, URS, risk assessments, scripts) and maintaining documentation within VLMS/QMS/EDMS ecosystems. AI literacy is a plus for this position.

Qualifications

• Requires a Bachelor’s degree in Life Science, IT, Engineering or a related field.
• 1-3 years in Computer System Validation (CSV) within biotech/pharma; CSA experience a plus.
• Knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity).
• Experience with automated VLMS for validation activities; QA alignment and documentation.

Responsibilities

• Execute and support CSV and CSA activities for GxP-regulated systems.
• Author and maintain validation documentation (plans, URS, risk assessments, test scripts, VLRs).
• Coordinate validation testing, document results, and resolve issues.
• Maintain validation docs using VLMS/EDMS/QMS; support Change Controls and CAPAs.
• Assist during internal/regulatory audits with validation documentation.

Skills

Communication skills

AI literacy

GxP regulatory knowledge

Risk-based methodologies

Cross-functional collaboration

Education

Bachelor’s degree in Life Science/IT/Engineering or related field

Tools

VLMS

EDMS

QMS

ValGenesis

Veeva Quality Vault

Job description

Legend Biotech in Somerset, NJ seeks an IT Validation Analyst to support validation activities for GxP-regulated systems. You will work with IT, QA, and vendors to ensure continued compliance across the system lifecycle.

The role requires creating validation deliverables (plans, URS, risk assessments, scripts) and maintaining documentation within VLMS/QMS/EDMS ecosystems. AI literacy is a plus for this position.