Validation Analyst

Role & Responsibilities

• Primary Need: Looking for a person who knows Lab X to handle rollout and ensure instruments are fully operational.
• Key Responsibilities:
• Instrument Rollout & Compliance
• For Lab X - Deploy instruments, ensure functionality, and validate connections.
• Work in gowning & process areas.
• Follow GxP, pharma/biotech regulations, and ALCOA principles.
• Software & IT Aspects
• System administration, and user access controls.
• Software rollout and data integrity considerations (data types, file types, software-database connections).
• Network & domain configurations.
• Validation & Documentation
• Equipment validation & troubleshooting.
• Work with ValGenesis.
• Heavy documentation responsibility, working alongside Software SMEs.
• IOQ, vendor coordination, preliminary and full PQ with Manufacturing & QC before release to production.
• Training & Support
• Train Manufacturing & QC teams on device usage.
• Conduct working sessions.

Job Requirements

• Experience in:
• GxP compliance, pharma/biotech.
• IT knowledge—networking, system configurations, troubleshooting.
• Software administration and validation.
• Equipment validation processes (IOQ, PQ, vendor coordination).
• Strong documentation skills.
• Knowledge of Lab X software.