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Csv validation specialist

Beerse
CDI
Panda International
Publiée le Publiée il y a 19 h
Description de l'offre

Job Title: CSV Validation Specialist

Industry: Pharmaceuticals / Life Sciences / Information Technology

Job Type: Contract

Location: Beerse, Belgium - Turnhoutseweg Site

Start Date: 11/08/2025

End Date: 10/02/2026

Duration: 6 Months

Work Authorization: Must be authorized to work in Belgium

Language Requirements: Fluent English and Dutch (spoken and written)

Job Description:

Our client, a global pharmaceutical leader, is seeking a CSV Validation Specialist with strong experience in IT and software validation within a regulated environment. The ideal candidate will have a solid grasp of the Software Development Life Cycle (SDLC), ideally with prior experience working at healthcare/pharmaceutical companie. This position is based at the Beerse campus (Turnhoutseweg) and requires an expert in Computer System Validation (CSV) aligned with industry best practices and internal compliance procedures, such as SOP-1705.

Key Responsibilities:

* Develop and execute validation strategies for computer system validation (CSV) projects in line with company and regulatory standards
* Create and maintain comprehensive documentation (validation plans, protocols, reports) per SOP-1705 and related procedures
* Perform risk assessments and define mitigation strategies for validation activities
* Lead or participate in testing phases including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
* Collaborate with IT, QA, and regulatory teams to ensure project compliance and timely delivery
* Ensure adherence to internal compliance policies and external regulatory requirements (e.g., FDA, ISO)
* Train and guide team members on CSV best practices and procedural adherence

Required Skills & Experience:

* 3-5 years of hands-on experience in computer system validation within a regulated pharmaceutical or healthcare environment
* Strong understanding of the SDLC and its application in CSV
* Prior experience with healthcare/pharmaceutical companies strongly preferred
* Proven track record in creating and managing validation documentation
* Strong analytical and problem-solving skills
* Excellent communication and collaboration abilities

Preferred Qualifications:

* Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field
* Knowledge of GxP, 21 CFR Part 11, and industry-specific validation regulations
* Familiarity with validation tools and methodologies

Interested? Send your CV to m.gomes@panda-int.com to discuss further!

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