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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.

Additional contact details

For further information, please apply or contact me directly. Jack Herod jherod@optimussearch.com