Subject Matter Expert in Computer System Validation (CSV)

☞ Hunter Careers

Ver: 103

Día de actualización: 29-11-2025

Ubicación: Zwijndrecht Antwerp

Categoría: Alta tecnología IT - Software Seguro de Calidad / Control de Calidad

Industria: IT Services IT Consulting

Posición: Mid-Senior level

Tipo de empleo: Full-time

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Contenido de trabajo

Job Title: Subject Matter Expert in Computer System Validation (CSV)

Location: Zwijndrecht, Belgium - Hybrid (3 days on-site, 2 days remote)

Contract Type: Full-Time

Contract Duration: Indefinite

Salary: Up to 5500 euro gross per month (senior profile) + company car, bonus, expense allowance, insurances, and more

We are a specialized career platform connecting candidates with premier career opportunities. Our AI career agent, Hunter, works 24/7 to match talented professionals with roles that align perfectly with their skills, contract preferences, and career aspirations, both through our direct client network and broader market opportunities.

About The Role

Join a technology-driven company as a Subject Matter Expert in Computer System Validation (CSV). In this exciting position, you’ll be involved in the most complex projects, applying your expertise to validate computer systems in the pharmaceutical industry. You’ll be part of a dynamic team known for its strong culture based on trust and ownership, actively participating in team meetings and teambuilding activities.

Responsibilities

  • Lead and manage validation projects for computer systems across various domains such as MES, LIMS, ERP, and SCADA.
  • Provide expert advice on CSV-related matters to ensure compliance with regulatory standards.
  • Develop validation protocols in accordance with industry guidelines and standards (e.g., ISA95, GAMP5).
  • Collaborate with cross-functional teams to drive project success.
  • Participate in regular reviews and audits to ensure ongoing compliance.
  • Contribute to continuous improvement initiatives within the CSV domain.

Requirements

  • Must reside within 50 miles of Zwijndrecht, Belgium.
  • Minimum of 10 years of experience in Computer System Validation within a GMP environment, preferably in the pharmaceutical or biotechnological industry.
  • Bachelor’s or Master’s degree in a technical or scientific field, or equivalent experience.
  • Profound knowledge of ISA95, GAMP5, USA FDA 21 CFR Part 210, 211, and 11, and EudraLex Vol.4.
  • Extensive experience with software application validation such as MES, LIMS, ERP, SCADA, BMS, and document management systems.
  • Strong analytical skills and structured approach.
  • Excellent communication skills in Dutch and English.
  • Proven ability to work both independently and as part of a team.
  • Experience with project management.

Preferred Skills

  • Broad general IT/automation knowledge including data exchange, data security, infrastructure, PLC, SCADA, and MES systems.
  • Knowledge of Data Integrity and ISO-13485.

Application Process

The first step will be with our AI career agent, Hunter, who’ll get to know you better to match you with this and other roles. Afterwards, you’ll be evaluated by the hiring team.

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Plazo: 13-01-2026

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