Junior CSV Engineer: GMP Validation & Healthcare Tech

MindCapture BV; Belgique; Sur place; EUR 30 000 - 42 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Résumé du poste

MindCapture BV is seeking a Junior CSV Engineer to support validation activities for computerised systems, equipment and IT applications within GMP-regulated environments. You will help prepare validation documentation, perform testing, and contribute to change control and qualification processes on client sites in Belgium.

As part of a consultancy role, you will engage with diverse stakeholders, build practical CSV experience, and support tech transfer and manufacturing process validation

Qualifications

• Education: Relevant scientific, engineering or technical educational background.
• CSV knowledge: Initial knowledge or experience in Computer System Validation.
• GMP knowledge: Understanding of working principles within a regulated GMP environment.
• IT validation: Interest in validating computerised systems and IT applications.
• Equipment qualification: Knowledge or initial experience with equipment qualification.
• Documentation skills: Ability to work accurately with structured technical documentation.
• Working style: Practical, hands on and comfortable taking ownership of assigned activities.
• Communication: Strong communication skills and ability to collaborate with different stakeholders.
• Independence: Ability to work independently while seeking guidance when required.
• Warehouse systems: Experience with Warehouse Management Systems is a plus.

Responsabilités

• Prepare, review and maintain validation documentation and protocols.
• Execute documented tests and accurately record validation results.
• Support validation of computerised systems within a GMP environment.
• Contribute to qualification activities for equipment and automated solutions.
• Support the preparation and execution of Site Acceptance Tests.
• Help prepare, document and follow up change controls.
• Evaluate system changes and their potential validation impact.
• Contribute flexibly to different validation and qualification projects.
• Lead validation activities for advanced cell therapy
• Support tech transfer and manufacturing process activities
• Drive compliant validation within a regulated environment
• Manage material lifecycle act across quality and operations
• Improve compliance, continuity, cost control and OPEX
• Optimise processes, data and systems using digital tools
• Build practical experience in CSV projects
• Support validation activities within GMP environments
• Lead commissioning across complex systems
• Coordinate testing, acceptance and operational handover
• Ensure safe execution within strict regulated environments
• Technical field support for diagnostic systems
• Regional role with customer interaction
• Ideal for junior engineers who want impact
• Execute validation of GMP critical computerised systems
• Ensure compliance with FDA and EU regulatory standards
• Generate validation documentation and resolve issues
• Qualify and validate equipment and processes

Connaissances

CSV knowledge

GMP knowledge

IT validation

Equipment qualification

Documentation skills

Working style

Communication

Independence

Warehouse systems

Formation

Relevant scientific, engineering or technical educational background

Description du poste

MindCapture BV is seeking a Junior CSV Engineer to support validation activities for computerised systems, equipment and IT applications within GMP-regulated environments. You will help prepare validation documentation, perform testing, and contribute to change control and qualification processes on client sites in Belgium.

As part of a consultancy role, you will engage with diverse stakeholders, build practical CSV experience, and support tech transfer and manufacturing process validation