Location
bilbao, kingdom of spain, Spain
Posted
July 19, 2026
Job Description
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 exp...
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 exp...