JOB SUMMARY

We are seeking a Computer System Validation (CSV) Engineer to support the validation and lifecycle management of GxP computer systems in our manufacturing and laboratory environments. This role is critical in ensuring regulatory compliance, data integrity, and consistent performance of computerised systems in accordance with FDA, EMA, GAMP 5, and other relevant regulations and guidelines.

• Plan, develop, execute, and document CSV activities in accordance with internal procedures and regulatory requirements.
• Author and review validation documentation such as Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ Protocols, and Reports.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and other relevant global regulatory guidelines.
• Collaborate with cross-functional teams including IT, Quality Assurance, Manufacturing, and Engineering to implement validated systems.
• Support audits and inspections by regulatory authorities and internal teams.
• Perform periodic reviews, change control assessments, and re-validation activities.
• Participate in project teams for new system implementations and upgrades.
• Provide training and guidance on CSV processes and best practices to internal stakeholders.