Role Overview:This role is for a Computer System Validation (CSV) Engineer with strong R&D domain knowledge, focusing on ensuring GxP compliance for various systems. The engineer will be responsible for applying core CSV principles and regulatory expertise within a pharmaceutical or life sciences R&D environment.
Key Responsibilities:- Ensure strict adherence to regulatory standards including 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, and ITIL.
- Author critical validation documentation such as User Requirement Specifications (URS), Functional Specifications (FS), protocols, final reports, and comprehensive validation plans/reports.
- Conduct activities related to audit/inspection readiness, periodic reviews, access roster management, and audit trail reviews.
- Manage deviations and Corrective and Preventive Actions (CAPA), ensuring full compliance with Standard Operating Procedures (SOPs) and company policies.
- Implement risk-based testing methodologies in alignment with Computer Software Assurance (CSA) fundamentals.
Required Skills:- Core expertise in Computer System Validation (CSV).
- In-depth knowledge of regulatory frameworks including 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, and ITIL.
- Experience in authoring URS/FS, protocols, final reports, and validation plans/reports.
- High-level understanding of Veeva Vault suites.
- Proficiency in risk-based testing aligned to CSA fundamentals.
- Experience with audit/inspection readiness, periodic reviews, access roster, and audit trail reviews.
- Competence in Deviation/CAPA management and SOP/policy compliance processes.
- High-level understanding of R&D domains such as Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, and R&D AI GxP.
Qualifications:- Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy.
- Over 8+ years of overall experience.
- At least 5 years of experience specifically in Computer System Validation for GxP systems.
Preferred Skills: 
