Senior CSV Validation & Compliance Analyst

Scorpion Therapeutics; Northbridge (MA); On-site; USD 129,000 - 163,000; Full time

Job summary

Scorpion Therapeutics seeks an IT System and Validation Analyst to provide QA oversight of validation and compliance for GxP-regulated computerized systems, ensuring they are implemented, maintained, and retired per global regulatory requirements.

The role partners with CSV SMEs across functions, owns lifecycle activities for deployments and decommissioning, authors validation deliverables, and maintains data integrity and change control.

Qualifications

• 5–7+ years direct CSV experience in pharma/biotech/medical devices.
• Experience with FDA 21 CFR Part 11, EU Annex 11, CSA guidance.
• Strong technical writing and analytical skills.
• Experience with validation lifecycle processes.

Responsibilities

• Align CSV processes with GAMP 5 and Part 11, CSA guidance.
• Own CSV lifecycle activities for implementations, upgrades, migrations, and decommissioning.
• Author/review/approve validation plans, IQ/OQ/PQ, and protocols.
• Maintain change control, deviations, CAPAs, and data integrity.
• Coordinate with vendors and support audits/inspections.

Skills

CSV experience

GxP compliance

Regulatory knowledge

Technical writing

Problem solving

Education

Bachelor’s in Engineering/Life Sciences/Computer Science

Master’s degree a plus

Job description

Scorpion Therapeutics seeks an IT System and Validation Analyst to provide QA oversight of validation and compliance for GxP-regulated computerized systems, ensuring they are implemented, maintained, and retired per global regulatory requirements.

The role partners with CSV SMEs across functions, owns lifecycle activities for deployments and decommissioning, authors validation deliverables, and maintains data integrity and change control.