Global CSV Expert: GxP IT Validation in Healthcare

Kuehne+Nagel; Wrocław; On-site; PLN 150,000 - 210,000; Full time

Job summary

Kuehne+Nagel is seeking an experienced Computer System Validation Expert to ensure GxP-compliant validation of core IT systems across our global Contract Logistics network. You will manage validation lifecycle activities, risk assessments, and documentation to support data integrity and patient safety.

Join a team that bridges IT, compliance, and healthcare logistics, working with Operations, IT, and QSHE/QM across multiple countries and external providers.

Qualifications

• A degree in Computer Science, Information Systems, Life Sciences, or a comparable qualification.
• Several years of experience in CSV/CSA within pharma, healthcare, life sciences, supply chain, or Contract Logistics.
• Strong knowledge of GxP requirements and validation frameworks (FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5).
• Experience validating IT applications such as WMS, temperature and humidity monitoring, and cloud/SaaS solutions, with understanding of IT infrastructure, software development, and application management.
• Excellent analytical, communication, and project management skills; experience with international and distributed teams and English proficiency.

Responsibilities

• Plan, execute, and document Computer System Validation activities in accordance with GxP regulations, including FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
• Create, review, execute, and maintain validation documentation such as SVMPs, URS, IQ/OQ/PQ documentation, and Validation Summary Reports.
• Perform risk and impact assessments and define appropriate validation approaches based on system criticality and GAMP 5 principles.
• Validate warehouse management, temperature and humidity monitoring, cloud-based/SaaS, and other business-critical IT systems.
• Support new system implementations, system changes, tenders, and the ongoing compliant operation of validated applications.
• Ensure data integrity and regulatory compliance throughout the system lifecycle.
• Provide CSV expertise and documentation during audits and inspections.
• Collaborate with Operations, IT, QSHE/QM, country organizations, and external service providers to ensure consistent validation standards globally.

Skills

GxP knowledge

CSV/validation

FDA 21 CFR Part 11

GMP Annex 11

GAMP 5

Risk assessment

Documentation

International collaboration

English communication

Education

Bachelor's degree in Computer Science

Bachelor's degree in Information Systems

Bachelor's degree in Life Sciences

Job description

Kuehne+Nagel is seeking an experienced Computer System Validation Expert to ensure GxP-compliant validation of core IT systems across our global Contract Logistics network. You will manage validation lifecycle activities, risk assessments, and documentation to support data integrity and patient safety.

Join a team that bridges IT, compliance, and healthcare logistics, working with Operations, IT, and QSHE/QM across multiple countries and external providers.