Senior CSV Validation Engineer — Hybrid (UK)

Autolus Ltd; Stevenage; Hybrid; GBP 65,000 - 95,000; Full time

Job summary

Autolus Ltd. in Stevenage seeks a hands-on Senior Engineer, Validation CSV to own the computerised-system lifecycle. You will collaborate with Quality, Manufacturing, Engineering and IT to deliver compliant validation solutions across cGMP with the Autolus QMS.

The role is based in Stevenage, offering a hybrid working pattern and a competitive package including a performance-related bonus and comprehensive benefits.

Qualifications

• Minimum 5+ years in Validation Engineer role within pharma/biopharma.
• Specialist CSV knowledge with data-integrity focus.
• Experience writing and executing validation/test protocols and lifecycle docs.
• Stakeholder engagement across functions and projects.
• Knowledge of FDA 21 CFR Part 11 and EU Annex11 and ISPE GAMP5.
• CSV project management experience; familiarity with SaaS/cloud validation.
• Understanding of AI/ML validation in a GxP setting.

Responsibilities

• Lead validation activities across projects per GAMP5 and regulatory expectations.
• Author and execute CSV documentation including IQ/OQ/PQ, traceability, and reports.
• Assess data integrity, electronic records/signatures compliance.
• Perform vendor assessments and manage CSV change controls and CAPAs.
• Train and mentor others on CSV requirements and quality system processes.
• Support regulatory inspections as CSV expert.

Skills

Validation

CSV

GxP

Data Integrity

Technical writing

Cross-functional collaboration

Regulatory audits

Education

Degree in computer science or related field

Tools

cGMP

GAMP5

Job description

Autolus Ltd. in Stevenage seeks a hands-on Senior Engineer, Validation CSV to own the computerised-system lifecycle. You will collaborate with Quality, Manufacturing, Engineering and IT to deliver compliant validation solutions across cGMP with the Autolus QMS.

The role is based in Stevenage, offering a hybrid working pattern and a competitive package including a performance-related bonus and comprehensive benefits.