CSV Engineer – Computer System Validation Specialist

About the role

As a CSV Engineer at Nalys, you will support pharmaceutical clients by ensuring the compliance and integrity of their computerized systems. You will work within a fast‑growing consultancy that blends high‑tech engineering expertise with a human‑centric approach.

Key responsibilities

• Execute validation activities for process equipment, laboratory instruments, and computerized systems in line with relevant guidelines.
• Prepare and maintain validation deliverables such as project plans, user requirements, risk assessments, test protocols, SOPs, and periodic reviews.
• Ensure adherence to US and other applicable regulations, as well as EHS requirements.
• Collaborate with manufacturing, IT, and laboratory teams to implement validation programs and drive continuous improvement.

Required profile

• Bachelor’s or Master’s degree in Computer Science, STEM, or a related scientific field.
• Strong knowledge of Computer System Validation (CSV) and IT regulations.
• Familiarity with GMP systems and Excel‑based validation workflows.
• Understanding of Project Management and Software Development Life Cycles.
• Excellent communication, leadership, and problem‑solving abilities.
• Ability to work independently and manage multiple priorities under strict deadlines.

Required skills

• Computer System Validation (CSV)
• Good Manufacturing Practice (GMP)
• Microsoft Excel
• Project Management
• Software Development Life Cycle (SDLC)