Computer Systems Validation (CSV) Engineer

External

Lonza · Belgium

Full-timeOn-siteToday

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About the role

As the Computer System Validation (CSV) Expert you will report directly to the local CSV manager and be the domain expert responsible for implementing Computer System Validations at our site in Verviers. You will contribute to the validation and lifecycle management of our computerized systems. As a key member of the CSV team, you will act as a trusted partner to operations, quality and OT, contributing to the compliance, reliability and lifecycle management of computerized systems. This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. https://www.youtube.com/watch?v=wZaXzPKWEv0&list=PLh3u2rKfWyIfXC2d2O3enUrpMjjJ7DO_x&index=18 What you will get: An agile career and dynamic working culture An inclusive and ethical workplace Compensation programs that recognize high performance A variety of benefits dependant on role and location The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits The full‑time annual base pay for this position in Belgium is expected to range between €63,750 and €89,250. Initial salary placement within this range will be determined based on role‑related factors such as experience, qualifications, and expected contribution.

Responsibilities

Leading full lifecycle validation for all applicable manufacturing, laboratory and computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and CSV procedure

Writing validation plan tasks such as Functional, Data Integrity and Audit Trail Risk Assessments; Test Protocols, test scripts and Reports (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)); Traceability Matrix and Validation Summary Report

Performing periodic reviews throughout system lifecycles to ensure systems are maintained in a validated state during their operational life

Prepare Computerized Systems Administration Work Instructions and CS Audit Trail Logbook

Compiling, maintaining and training managers regarding accurate CSV documentation, ensuring full traceability across its lifecycle

Working with process owners to identify and implement new systems and upgrade existing systems to aid improvements to compliance and reduce risks to patient safety, product quality and data integrity

Participating in both internal and external audit inspections from a CSV perspective

Key requirements:

Experience in Computer System Validation (CSV) within the life sciences or other regulated industries

Proven experience working in CSV in a GxP-regulated environment

Strong knowledge of GAMP5, GxP regulations (Eudralex Volume 4 Part 11 and 21 CFR Part 11), and data integrity principles

In-depth understanding of GAMP5 and a broad knowledge of validation principles and methodologies

Good familiarity with FDA, MHRA, and other regulatory authorities' requirements related to GxP, data integrity, and data governance

Demonstrated ability to manage multiple tasks and priorities effectively in a fast-paced environment

Solution-oriented mindset with strong prioritization skills and the ability to manage multiple projects simultaneously

Commitment to continuous improvement, with a strong focus on eliminating waste and maximizing value for stakeholders

Proficiency in both French and English, with strong written and verbal communication skills

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Computer Systems Validation (CSV) Engineer

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