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.
  

• 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.