Junior CSV Engineer

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

At MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

• A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card
• Personal growth support with tailored training and clear career development
• A stable environment where your technical skills directly contribute to improved patient care
• The chance to work with high tech diagnostic systems at top tier healthcare institutions
• A warm and collaborative culture focused on trust, ownership and long term impact

As a Junior CSV Engineer, you will support our client with validation and qualification activities across computerised systems, IT applications and equipment. You will contribute to projects within automated operational environments while developing practical experience in validation documentation, testing, change control and GMP compliance.

Key responsibilities

• Validation documentation: Prepare, review and maintain validation documentation and protocols.
• Test execution: Execute documented tests and accurately record validation results.
• System validation: Support validation of computerised systems within a GMP environment.
• Equipment qualification: Contribute to qualification activities for equipment and automated solutions.
• Acceptance testing: Support the preparation and execution of Site Acceptance Tests.
• Change control: Help prepare, document and follow up change controls.
• Impact assessment: Evaluate system changes and their potential validation impact.
• Project support: Contribute flexibly to different validation and qualification projects.

Required competences & skills

• 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.
  

Additional responsibilities

• 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

About this application

This opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client.

MindCapture supports you throughout your assignment with clear onboarding, regular follow up and access to learning opportunities. You will have a dedicated point of contact, transparent communication and support to help you deliver impact in a structured way.

Job Contact – Talent & Business Team

Our Talent & Business Managers combine a deep understanding of our clients’ needs with a sharp eye for talent. Their focus is on creating meaningful and sustainable matches, always keeping both the role and the candidate in mind.

When a potential match is identified, one of our T&B colleagues may reach out to answer your questions, share additional context about the role and discuss possible next steps together, with clarity and transparency throughout the process.