Senior CSV Lead – Computer System Validation Engineer

About the role

We are looking for an experienced Computer System Validation (CSV) Lead to manage validation activities for a large‑scale Manufacturing Execution System (MES) programme in a regulated environment. The role will ensure GxP, GAMP 5 and other regulatory compliance while collaborating with Quality, Manufacturing, IT and Engineering teams.

Key responsibilities

• Lead CSV activities for MES implementations, upgrades and enhancements.
• Develop and review validation documentation such as Validation Plans, URS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols and Validation Summary Reports.
• Execute risk‑based validation aligned with GAMP 5 principles and regulatory expectations.
• Coordinate qualification activities (IQ/OQ/PQ) with cross‑functional teams.
• Support supplier assessments, software documentation reviews, deviations, CAPA activities and audit readiness.
• Provide validation guidance, reporting and continuous improvement support.

Required profile

• Proven experience leading CSV activities in pharma, life‑sciences or other regulated environments.
• Strong knowledge of GxP, GAMP 5, FDA 21 CFR Part 11 and EU Annex 11.
• Experience creating and reviewing validation lifecycle documentation.
• Background validating enterprise systems such as MES, ERP or LIMS.
• Understanding of SDLC and validation lifecycle methodologies.
• Experience working in Agile or hybrid project environments.
• Excellent stakeholder management and documentation skills.

Required skills

• Computer System Validation (CSV)
• GAMP 5
• FDA 21 CFR Part 11
• EU Annex 11
• MES platforms (e.g., Emerson Syncade)
• ERP systems
• LIMS
• Software Development Life Cycle (SDLC)
• Agile project methodology