Senior Computer System Validation (CSV) Consultant – English, German
Work on challenging international projects with leading pharmaceutical, biotechnology and medical device companies across Germany, Switzerland and Europe. Flexible remote‑first working model.

What You’ll Be Doing

Leading Computer System Validation (CSV) activities throughout the system lifecycle

Developing validation strategies and documentation in accordance with GAMP® 5 (2nd Edition)

Supporting implementation and validation of regulated IT systems including ERP, LIMS, MES, Veeva Vault, eQMS and Document Management Systems

Performing GxP risk assessments and supplier assessments

Supporting audit and inspection readiness activities

Collaborating with business, IT, quality and external vendors across international project teams

Advising clients on best practices for Computer System Validation and Computer System Assurance (CSA)

Qualifications

Minimum 5 years of experience in Computer System Validation (CSV) within the pharmaceutical,



biotechnology or medical device industry

Strong understanding of GAMP® 5, EU Annex 11, 21 CFR Part 11 and GxP requirements

Experience with one or more of the following technologies: SAP, Veeva Vault, LabWare or Labvantage LIMS, MES, TrackWise, Document Management Systems, ERP implementations

Experience working in international project environments

Fluent English (required) and German (preferred)

Excellent communication and stakeholder management skills

Experience with Computer System Assurance (CSA), Data Integrity or Digital Quality is highly desirable

Benefits

Opportunity to work alongside highly experienced consultants on complex integral transformation programmes

Flexible collaboration models (permanent employment or freelance)

Competitive hourly rates or salary depending on experience and engagement model

📌 Senior Validation Consultant (Bilbao)
🏢 Qualitice
📍 Bilbao