CSV Engineer

Job Summary

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

Key Responsibilities

• Plan, develop, execute, and document CSV activities in accordance with internal procedures and regulatory requirements.
  
• Author and review validation documentation such as Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ Protocols, and Reports.
  
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and other relevant global regulatory guidelines.
  
• Collaborate with cross-functional teams including IT, Quality Assurance, Manufacturing, and Engineering to implement validated systems.
  
• Support audits and inspections by regulatory authorities and internal teams.
  
• Perform periodic reviews, change control assessments, and re-validation activities.
  
• Participate in project teams for new system implementations and upgrades.
  
• Provide training and guidance on CSV processes and best practices to internal stakeholders.
  

Requirements

Qualifications

Required:

• Bachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences, or related field.
  
• Minimum of 3–5 years of experience in CSV within the pharmaceutical, biotech, or life sciences industry.
  
• Strong understanding of GxP regulations, GAMP 5, data integrity principles, and validation lifecycle.
  
• Experience with systems such as LIMS, MES, ERP, SCADA, or laboratory equipment with software components.
  
• Proficient in English; German language skills are a strong advantage.
  
• Job is remote with some occasional travel to Germany when needed.
  

Preferred:

• Experience in an international pharmaceutical environment.
  
• Familiarity with Agile or V-model methodologies.
  
• Knowledge of cybersecurity principles as they relate to validated systems.
  
• Ability to manage multiple validation projects in parallel.