Computer System Validation (CSV) Consultant

About us

Computer System Validation (CSV) Consultant

Location: Vienna, Austria

Type: Permanent

I'm working with a leading engineering consultancy supporting some of Europe's largest pharmaceutical and biotechnology projects who is looking to strengthen its Computer System Validation capability.

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.