CSV Engineer

Greater Frankfurt, Germany | Posted on 08/08/2025

We are seeking a Computer System Validation(CSV) Engineer to support the validation and lifecycle management of GxPcomputer systems in our manufacturing and laboratory environments. This role iscritical in ensuring regulatory compliance, data integrity, and consistentperformance of computerised systems in accordance with FDA, EMA, GAMP 5, andother relevant regulations and guidelines.

KeyResponsibilities

• Plan,develop, execute, and document CSV activities in accordance with internalprocedures and regulatory requirements.
  
• Authorand review validation documentation such as Validation Plans, UserRequirements Specifications (URS), Risk Assessments, IQ/OQ/PQ Protocols,and Reports.
  
• Ensurecompliance with 21 CFR Part 11, EU Annex 11, and other relevant globalregulatory guidelines.
  
• Collaboratewith cross-functional teams including IT, Quality Assurance,Manufacturing, and Engineering to implement validated systems.
  
• Supportaudits and inspections by regulatory authorities and internal teams.
  
• Performperiodic reviews, change control assessments, and re-validationactivities.
  
• Participatein project teams for new system implementations and upgrades.
  
• Providetraining and guidance on CSV processes and best practices to internalstakeholders.
  

Requirements

Qualifications

Required:

• Bachelor’sor Master’s degree in Engineering, Computer Science, Life Sciences, orrelated field.
  
• Minimumof 3–5 years of experience in CSV within the pharmaceutical, biotech, orlife sciences industry.
  
• Strongunderstanding of GxP regulations, GAMP 5, data integrity principles, andvalidation lifecycle.
  
• Experiencewith systems such as LIMS, MES, ERP, SCADA, or laboratory equipment withsoftware components.
  
• Proficientin English; German language skills are a strong advantage.
  
• Job isremote with some occasional travel to Germany when needed.
  

• Experiencein an international pharmaceutical environment.
  
• Familiaritywith Agile or V-model methodologies.
  
• Knowledgeof cybersecurity principles as they relate to validated systems.
  
• Abilityto manage multiple validation projects in parallel.