Senior Engineer, CSV Validation
HybridStevenage, England, United Kingdom
Job Summary
Define validation requirements and execute computer systems validation activities for CSV reports, ensuring compliance with MHRAs Orange Guide, EU EudraLex Vol. 4, USA CFRs, ISO, ICH, GAMP, and PIC/S. Author User Requirement Specifications, Validation Plans, functional documentation, data migration plans, and traceability matrices while managing vendor assessments, change controls, CAPAs, and non-conformances. Maintain validated states for computerised systems through periodic reviews, incident management, and user training, supporting regulatory authority inspections as a subject matter expert. Work Monday through Friday in a hybrid model in Stevenage, UK, partnering with Quality, Manufacturing, Engineering, and IT to deliver compliant, risk-based solutions for Autolus's T cell therapies.
Required Qualifications
- Prior experience of Validation within biopharmaceutical or pharmaceutical manufacturing environment (Minimum of 5+ years in Validation Engineer role)
- Specialist knowledge of CSV derived independently through both practical experience and theoretical studies
- Experience developing and execution of computerised system validation test protocols & validation lifecycle documentation
- Experience of engaging and dealing project stake holders and work cross functionally
- An Understanding of CSV requirements in accordance with FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines
- Minimum of degree in computer science or a related scientific or technical discipline, or equivalent relevant experience
- Demonstrate understanding of Computer Systems Validation (CSV) and Data Integrity (DI) requirements for regulated industries and its development life cycle approach
- Strong technical authoring skills
- Thorough knowledge of cGMP & GAMP as applied in biopharmaceutical or related industry
- Proven ability to meet timelines, prioritise tasks and engage with stakeholders
- Good communication skills and the ability to train people if required in CSV
- Ability to work with cross functional teams internally and externally to Autolus
Desired Qualifications
- Familiarity of SaaS/Cloud based systems validation utilising modern CSA approach
- Understanding of validation/assurance of AI and ML enabled systems, preferably in a GxP environment
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