Compute System Validation (CSV) with R&D Knowledge

The Computer System Validation (CSV) Specialist/Engineer with R&D knowledge is responsible for ensuring that computerized systems used in R&D, laboratory, clinical, and regulated life-sciences environments are validated and maintained in compliance with GxP, FDA, and applicable regulatory requirements. The role combines CSV expertise with an understanding of R&D workflows, laboratory systems, scientific applications, and data integrity.

• 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
• Authoring of URS/FS, protocols, final reports, validation plan/report
• High-level understanding of Veeva Vault suits
• Risk-based testing aligned to CSA fundamentals

Education and experience :

• Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy
• Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system
• High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP
• Develop and execute Computer System Validation (CSV) strategies for GxP-regulated R&D systems.
• Prepare and maintain validation plans, risk assessments, URS, FS/DS, IQ/OQ/PQ, test scripts, traceability matrices, and validation reports.
• Support validation of laboratory and R&D applications such as LIMS, ELN, CDS, SDMS, scientific software, and laboratory instruments.
• Perform GxP impact assessments and risk assessments.
• Ensure systems comply with 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, and applicable FDA requirements.
• Collaborate with R&D scientists, laboratory personnel, IT, QA, Regulatory, and system owners.
• Review system requirements, configuration specifications, test results, and deviations.
• Support change control, deviation, CAPA, periodic review, and system retirement activities.
• Investigate validation failures and coordinate root-cause analysis and remediation.
• Support vendor qualification and validation activities for SaaS/cloud and commercial systems.
• Ensure complete and inspection-ready validation documentation.
• Participate in internal and regulatory audits and provide validation evidence.
• Support system upgrades, releases, patches, and implementation projects.
• Maintain validation status throughout the system lifecycle.
• Promote data integrity and compliance across R&D computerized systems