What are the responsibilities and job description for the Computer System Validation Engineer position at United Pharma?
About the Job:
We are seeking an experienced Computer System Validation (CSV) Engineer to support GxP computerized systems within a Gene Therapy manufacturing environment. This role will be responsible for ensuring regulated systems remain validated, compliant, and inspection-ready while supporting critical manufacturing, laboratory, quality, and facility operations.
Key Responsibilities:
• Author, review, and execute validation deliverables including Validation Plans, URS, IQ/OQ/PQ, RTM, and Validation Reports
• Support validation of GxP systems such as Veeva Vault QMS, BMRAM, ERP systems, laboratory instruments, and Building Management Systems (BMS)
• Perform risk assessments and ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and Data Integrity requirements
• Manage Change Controls, Deviations, CAPAs, and Periodic Reviews for validated systems
• Support system upgrades, patches, migrations, and enhancements while maintaining validated status
• Collaborate with QA, IT, Facilities, Manufacturing, and Laboratory teams to ensure regulatory compliance and operational excellence
Qualifications:
• 5–7 years of CSV experience in Pharmaceutical, Biotechnology, Gene Therapy, or Medical Device industries
• Strong understanding of GAMP 5, FDA regulations, Data Integrity, and computerized system compliance
• Experience validating laboratory instruments, quality systems, ERP applications, or facility automation systems
• Strong technical writing, documentation, and protocol execution skills