Role: Computer System Validation (CSV) Specialist
Job Type: Freelance/Contract
Client: IBU
Location: Brussels, Belgium (3 Days onsite)
Experience Required: 7–8 years
Languages: French (mandatory), English (preferred)
Job Summary:
We are seeking a skilled and experienced Computer System Validation (CSV) Specialist to join our client’s quality and compliance division based in Brussels. The successful candidate will be responsible for defining and executing CSV strategy across GxP and non-GxP systems, ensuring full compliance with regulatory and internal quality requirements.
Key Responsibilities:
* Work with project stakeholders to define validation planning and scheduling in alignment with project timelines.
* Conduct risk assessments and determine GAMP categories for computerized systems.
* Define and document the CSV strategy for IT systems (both GxP and non-GxP).
* Review and approve all CSV documentation, including:
* User Requirements Specifications (URS)
* Functional & Design Specifications (FS/DS)
* Risk Assessments
* Validation Plan, IQ/OQ/PQ Protocols
* SOPs and Traceability Matrices
* Validation Summary Reports
* Ensure all deliverables align with regulatory standards such as GAMP 5, 21 CFR Part 11, Annex 11, etc.
* Participate in functional testing, validation execution, and defect tracking.
* Lead and support project meetings and audits related to CSV activities.
Required Skills & Qualifications:
* 7–8 years of hands-on experience in Computer System Validation within life sciences, pharmaceuticals, or medical devices.
* Solid knowledge of GAMP 5, Annex 11, and 21 CFR Part 11 regulations.
* Practical experience in writing, reviewing, and executing all phases of the CSV lifecycle documentation.
* Strong understanding of functional testing and validation test execution.
* Excellent communication and stakeholder management skills.
* Fluent French (spoken and written) is required; English proficiency is highly desirable.
Nice to Have:
* Experience with LIMS, MES, ERP, or other enterprise systems in a regulated environment.
* Exposure to digital transformation or cloud validation projects.
* CSV-related certifications or formal training.