Computer System Validation (CSV) Specialist

About the role

The CSV Specialist plans, executes, and documents computer system validation activities for GxP‑regulated systems in a pharmaceutical manufacturing environment, ensuring compliance with FDA 21 CFR Part 11, GAMP 5 and global regulatory requirements.

Key responsibilities

• Develop and execute validation deliverables such as Validation Plans, URS, Functional/Design Specifications, Risk Assessments, IQ/OQ/PQ protocols and Validation Summary Reports.
• Validate GxP systems including LIMS, MES, ERP, EDMS, building automation and related interfaces, applying a risk‑based GAMP 5 approach.
• Author and run test scripts, document deviations, support root‑cause investigations and CAPAs.
• Maintain validated state through periodic reviews, change control assessments and re‑validation activities.
• Collaborate with IT, Quality, Engineering and end‑users on system implementations, upgrades, migrations and decommissioning.
• Support internal and external audits by providing validation documentation and responding to inspector inquiries.

Required profile

• Bachelor's degree in Computer Science, Engineering, Life Sciences, IT or related field.
• 5+ years of experience in Computer System Validation within pharmaceutical, biotech or medical device environments.
• Experience supporting FDA, EMA or other regulatory inspections.

Required skills

• Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11 and data integrity (ALCOA+).
• Proficiency in authoring and executing IQ/OQ/PQ protocols and related technical documentation.
• Experience with validation of LIMS, MES, SCADA, ERP (e.g., SAP), EDMS and Building Management Systems.
• Understanding of SDLC, risk‑based validation methodologies and Computer Software Assurance.
• Excellent written and verbal communication for cross‑functional collaboration.