Process Validation Engineer Cell Therapy

MindCapture BV; Belgique; Sur place; EUR 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Company car with charging or fuel card

On-site training

Résumé du poste

MindCapture BV is seeking a Process Validation Engineer for Cell Therapy to coordinate validation activities in a new manufacturing environment. You will oversee validation strategy, approvals, and documentation while ensuring GMP compliance and regulatory alignment.

Ideal candidates hold a technical degree and have experience in regulated pharma/biotech settings, including sterile environments and technology transfer.

Qualifications

• Bachelor degree or higher in engineering, biotechnology, biomedical sciences or pharmacy.
• Experience within pharmaceutical, biotechnology, cell therapy or related regulated industry.
• Manufacturing knowledge: experience introducing pharmaceutical products into manufacturing environments.
• Technical expertise: working knowledge of manufacturing operations and late-stage development activities.
• GMP knowledge: strong working knowledge of current Good Manufacturing Practices.
• Aseptic experience: experience within controlled cleanroom environments under aseptic conditions is a plus.
• Project management: ability to manage activities, priorities and reporting in a structured way.
• Fluency in Dutch and English (written and spoken).

Responsabilités

• Define, plan and coordinate validation activities including PPQ, smoke studies, hold time validation, APQ and APS.
• Provide technical guidance on validation and qualification activities.
• Ensure timely revalidation of manufacturing and sterilisation processes.
• Write, review and approve validation plans, protocols and reports.
• Participate in product transfer and manufacturing system introduction activities.
• Contribute to optimisation projects for manufacturing systems and processes.
• Review technical documentation against regulatory requirements and current industry practices.
• Provide accurate progress updates to stakeholders and leadership.
• Lead validation activities for advanced cell therapy and related GMP computerised systems.
• Support tech transfer and manufacturing process activities.

Connaissances

Process validation

Regulatory compliance

GMP

Project management

Aseptic environments

Cross-functional collaboration

Formation

Bachelor degree or higher in engineering/biotech/biomedical/pharmacy

Description du poste

Jobs / Process Validation Engineer Cell Therapy

Process Validation Engineer Cell Therapy

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 Process Validation Engineer, you will coordinate validation activities within a new manufacturing environment. Your scope includes process validation, sterilisation validation, technology transfer, equipment introduction and technical documentation while ensuring compliance with current regulatory and GMP requirements.

Key responsibilities

• Validation strategy: Define, plan and coordinate PPQ, smoke studies, hold time validation, APQ and APS activities.
• Validation guidance: Provide technical guidance on validation and qualification activities.
• Revalidation: Ensure timely revalidation of manufacturing and sterilisation processes.
• Documentation: Write, review and approve validation plans, protocols and reports.
• Technology transfer: Participate in product transfer and manufacturing system introduction activities.
• Process improvement: Contribute to optimisation projects for manufacturing systems and processes.
• Compliance review: Review technical documentation against regulatory requirements and current industry practices.
• Project reporting: Provide accurate and timely progress updates to stakeholders and leadership.
• 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

Required competences & skills

• Education: Bachelor degree or higher in engineering, biotechnology, biomedical sciences or pharmacy.
• Industry experience: Experience within pharmaceutical, biotechnology, cell therapy or a related regulated industry.
• Manufacturing knowledge: Experience introducing pharmaceutical products into manufacturing environments.
• Technical expertise: Working knowledge of manufacturing operations and late stage development activities.
• GMP knowledge: Strong working knowledge of current Good Manufacturing Practices.
• Aseptic experience: Experience within controlled cleanroom environments under aseptic conditions is a plus.
• Project management: Ability to manage activities, priorities and reporting in a structured way.
• Problem solving: Strong decision making and problem solving skills under changing priorities.
• Collaboration: Ability to work independently while interacting effectively across organisational levels.
• Languages: Fluent written and spoken Dutch and English.

CQV Ghent Medior At MindCapture as consultant

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.