Senior CSV Engineer (Automation, IT/OT & CSV)

Quick Facts

• Role: Senior CSV Engineer (Automation, IT/OT & CSV)

• Domain: Pharma/Biotech computerised & automated systems

Description

As a CSV Engineer, you play a central role in the planning, implementation, and validation of computerised and automated systems in the pharma/biotech industry. You collaborate from technical conception through specification and implementation to successful validation, ensuring reliable, safe, and GMP-compliant outcomes.

Responsibilities

• Plan, implement, and validate computerised and automated systems

• Support system definition from technical concept through specification and implementation to validation

• Own automation systems and process control systems

• Work on monitoring, track-and-trace, and MES solutions

• Contribute to ERP, LIMS, and complex IT/OT infrastructures

• Coordinate disciplines and assess technical interfaces for a reliable, safe, and GMP-conform implementation

Requirements

• Experience in Computerised System Validation (CSV)

• Ability to understand complex technical interdependencies

• Active involvement in planning, implementation, and validation

• Technical understanding and regulatory expertise for computerised and automated systems

Benefits

• End-to-end ownership of the lifecycle from conception to validation

• Blend automation/IT-OT engineering with regulatory CSV expertise

• Varied projects across automation, MES, and enterprise/IT-OT infrastructure