Biopharma Process Validation Engineer (Ghent, Hybrid)

MindCapture BV; Oost-Vlaanderen; Híbrido; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

meal vouchers

eco vouchers

DKV health insurance

group insurance

net expense allowance

a company car

Descripción de la vacante

MindCapture BV in Ghent, Belgium, is seeking two Process Validation Consultants to support ongoing manufacturing validation activities in a highly regulated biopharma environment. The role combines scientific expertise with hands-on validation experience to ensure robust, compliant processes.

The position is based in Ghent with hybrid work, requiring fluency in English (Dutch desirable). Minimum 3 years of GMP experience and a Master’s degree in a related field are required.

Formación

• Master’s degree in Biotechnology or related scientific discipline.
• Minimum 3 years of experience in GMP regulated manufacturing, quality or development.
• Experience with process validation and manufacturing process qualification.
• Understanding of aseptic manufacturing processes and contamination control.

Responsabilidades

• Design, coordinate and execute process validation activities for routine manufacturing operations and strategic projects.
• Develop and maintain process validation strategies, master plans and manufacturing documentation.
• Design and oversee validation studies including PPQ, aseptic simulations, smoke studies, CCIT and hold time studies.
• Prepare, review and approve validation protocols, reports, risk assessments and SOPs.
• Contribute to contamination control strategies, sterility assurance and process control development.
• Support process transfers, validation activities and process improvements.
• Ensure GMP compliance and validation readiness per regulations and quality procedures.
• Support investigations, deviations, change controls and CAPAs with technical assessments.
• Act as SME during internal and external regulatory audits.
• Identify and implement improvements for quality, safety, productivity, yield and efficiency.
• Collaborate with suppliers and partners to assess materials and technologies.
• Support data collection, trend analysis and continuous verification.

Conocimientos

Process validation

Aseptic manufacturing

GMP knowledge

Statistical analysis

Regulatory audits

Documentation drafting

Stakeholder management

Educación

Master’s degree in Biotechnology

Herramientas

Statistics software

Descripción del empleo

MindCapture BV in Ghent, Belgium, is seeking two Process Validation Consultants to support ongoing manufacturing validation activities in a highly regulated biopharma environment. The role combines scientific expertise with hands-on validation experience to ensure robust, compliant processes.

The position is based in Ghent with hybrid work, requiring fluency in English (Dutch desirable). Minimum 3 years of GMP experience and a Master’s degree in a related field are required.