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.
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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.
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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
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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
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Performing periodic reviews throughout system lifecycles to ensure systems are maintained in a validated state during their operational life
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Prepare Computerized Systems Administration Work Instructions and CS Audit Trail Logbook
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Compiling, maintaining and training managers regarding accurate CSV documentation, ensuring full traceability across its lifecycle
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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
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Participating in both internal and external audit inspections from a CSV perspective
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
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
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.
