Senior CSV Validation Engineer - Hybrid

Autolus, Inc.; United Kingdom; Hybrid; GBP 70,000 - 100,000; Full time

Benefits offered by this job

Private medical insurance

Life assurance

Pension

Performance bonus

Comprehensive benefits package

Job summary

Autolus is seeking a hands-on Senior Engineer, Validation CSV, to own the computerised-system lifecycle in Stevenage. You will partner with Quality, Manufacturing, Engineering and IT to deliver compliant CSV solutions across GxP operations in CAR‑T cell therapy manufacturing.

The role requires 5+ years in validation, strong GAMP5 knowledge, data integrity and regulatory-inspection experience, plus excellent technical writing and cross‑functional collaboration.

Qualifications

• Minimum 5+ years in validation engineering in biopharma/pharma manufacturing.
• Proven ability to author, execute, and report validation lifecycle docs.
• Experience with FDA, EMA, MHRA regulatory inspections.
• Knowledge of GxP and data integrity concepts.
• Strong cross-functional collaboration with QA, Manufacturing, IT.

Responsibilities

• Define validation requirements per MHRA, EU, USA regulations (GxP).
• Implement best practices for CSV per GAMP 5.
• Author and execute validation plans, URS, IQ/OQ/PQ, reports.
• Assess data integrity and electronic records/signatures.
• Perform vendor assessments and change controls.
• Train staff on CSV requirements.
• Support regulatory inspections as CSV SME.
• Provide status updates to line manager.

Skills

CSV validation

GAMP5 knowledge

Data integrity

Regulatory audits

Stakeholder management

Technical writing

Project management

Cloud validation

AI/ML in GxP

Education

Degree in computer science or related field

Job description

Autolus is seeking a hands-on Senior Engineer, Validation CSV, to own the computerised-system lifecycle in Stevenage. You will partner with Quality, Manufacturing, Engineering and IT to deliver compliant CSV solutions across GxP operations in CAR‑T cell therapy manufacturing.

The role requires 5+ years in validation, strong GAMP5 knowledge, data integrity and regulatory-inspection experience, plus excellent technical writing and cross‑functional collaboration.