CSV Engineer – Computer System Validation (Pharma)

About the role

The CSV Engineer will lead Computer System Validation activities for pharmaceutical manufacturing systems, ensuring compliance with GMP, GAMP5, and 21 CFR Part 11. You will work closely with Automation, IT, Quality, and external vendors to deliver validated digital manufacturing solutions.

Key responsibilities

• Deliver full CSV lifecycle for SynTQ Syncade, including test script development, validation protocols, and RTMs for recipe management, EBR, and workflows.
• Validate MES configurations, master data, audit trails, and electronic signatures in line with regulatory standards.
• Coordinate FAT/SAT and system acceptance testing, manage integration with automation systems, and resolve validation deviations.
• Create and maintain Qualification Plans, Validation Test Plans, and SDLC documentation templates.
• Support project scheduling, validation tracking, and document management while liaising with suppliers and stakeholders.

Required profile

• 5+ years of experience in Computer System Validation within pharmaceutical or life‑science manufacturing.
• Strong knowledge of GAMP5 methodology, GMP, and 21 CFR Part 11 requirements.
• Proven ability to produce high‑quality validation documentation and manage vendor relationships.

Required skills

• Computer System Validation (CSV)
• GAMP5 methodology
• GMP & 21 CFR Part 11 compliance
• FAT/SAT oversight
• Requirements Traceability Matrix (RTM) creation
• SDLC documentation and validation lifecycle