Computer System Validation (CSV) Consultant (m/f/d)

Tasks

This position will suit an experienced CSV professional who can operate independently within GMP-regulated environments and provide technical expertise directly to pharmaceutical clients.

Responsibilities:

• Validation of GMP computerised systems throughout the full lifecycle
• Development and execution of validation documentation
• Support of regulatory inspections and audit readiness activities
• Validation of MES, SAP and Process Automation Systems
• Client-facing consulting and compliance support

Profile

Requirements:

• Proven Computer System Validation experience within Pharma or Biotech
• Strong understanding of GAMP 5, EU GMP Annex 11 and 21 CFR Part 11
• Experience validating MES, SAP and/or Automation Systems
• Ability to lead validation activities independently
• Fluent German and English

We offer

The successful candidate will join an established team delivering projects across Europe whilst benefiting from long-term career development and exposure to complex GMP manufacturing facilities.