Computer System Validation (CSV) Expert

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

It's more than a job Join a global role at the intersection of IT, compliance, and healthcare logistics, where you will ensure the regulatory integrity of validated warehouse management and temperature and humidity monitoring systems.

As a Computer System Validation (CSV) Expert within our Global Contract Logistics IT organization, you will safeguard data integrity and enable compliant operations across our international logistics network. Working closely with Operations, IT, QSHE/QM teams, countries, and external service providers, you will help create and maintain robust GxP-compliant digital environments. This is an opportunity to combine IT expertise with regulatory compliance in an environment where reliable systems directly contribute to product quality and patient safety. As a Computer System Validation Expert, you will take ownership of validation activities for business-critical IT systems within our global Contract Logistics environment. You will ensure that systems are implemented, maintained, and changed in accordance with applicable GxP requirements and internal validation standards. You will support the complete validation lifecycle, from initial risk and impact assessments through validation planning, testing, documentation, implementation, and ongoing compliance. In addition, you will provide your expertise during system changes, tenders, audits, and inspections.

How you create impact

• 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 internal and external audits and regulatory inspections
• Collaborate with Operations, IT, QSHE/QM, country organizations, and external service providers to ensure consistent validation standards globally

What we would like you to bring

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

What's in it for you

This role offers the opportunity to shape validation standards for business-critical systems across a global Contract Logistics network. You will work at the intersection of technology, regulatory compliance, and healthcare logistics, collaborating with international experts across IT, Operations, and Quality. Your work will have a tangible impact: by ensuring that our digital environments remain validated, reliable, and compliant, you will help protect data integrity, product quality, and ultimately patient safety.

Who we are

Logistics shapes everyday life - from the goods we consume to the healthcare we rely on. At Kuehne+Nagel, your work goes beyond logistics; it enables both ordinary and special moments in the lives of people around the world. As a global leader with a strong heritage and a vision to move the world forward, we offer a safe, stable environment where your career can make a real difference. Whether we help deliver life‑saving medicines, develop sustainable transportation solutions or support our local communities, your career will contribute to more than you can imagine.

We kindly advise that placement agencies refrain from submitting unsolicited profiles. Any submissions of candidates without prior signed agreement will be considered our property and no fees will be paid.