Process Validation Engineer

Process Validation Consultant | Biopharma | Ghent

Are you passionate about process validation, aseptic manufacturing and ensuring the highest quality standards in the biopharmaceutical industry?

We are looking for two Process Validation Consultants to support our client in Ghent with ongoing manufacturing validation activities and strategic projects focused on process optimisation, contamination control and manufacturing capacity expansion.

In this role, you will combine scientific expertise with hands on validation experience to ensure robust, compliant and efficient manufacturing processes within an innovative cell and gene therapy environment.

Location: Ghent, Belgium | Hybrid

Experience: Minimum 3 years

We offer competitive salaries, a full benefits package:

• meal vouchers
• eco vouchers
• DKV health insurance
• group insurance
• net expense allowance
• a company car

You also get the opportunity to shape your future through personalised training and development.

At MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most.

You will work as a MindCapture consultant for an international market leader in the healthcare industry.

Job Description:

As a Process Validation Consultant, you will support the design, execution and continuous improvement of process validation activities within a highly regulated biopharmaceutical manufacturing environment.

You will collaborate with manufacturing, quality, engineering and technical experts to ensure process robustness, regulatory compliance and successful implementation of manufacturing improvements.

Your responsibilities will include:

• Design, coordinate and execute process validation activities supporting routine manufacturing operations and strategic projects.
• Develop and maintain process validation strategies, validation master plans and manufacturing documentation.
• Design and oversee validation studies, including Process Performance Qualification (PPQ), aseptic process simulations, smoke studies, filter integrity testing, container closure integrity testing (CCIT) and hold time studies.
• Prepare, review and approve validation protocols, reports, risk assessments, manufacturing batch records and SOPs.
• Contribute to the development and implementation of robust process control and contamination control strategies, including sterility assurance.
• Provide scientific and technical expertise to support manufacturing process transfers, validation activities and process improvements.
• Ensure GMP compliance and validation readiness in accordance with applicable regulations and internal quality procedures.
• Support investigations, deviations, change controls and CAPAs by providing technical assessments, root cause analysis and product quality impact evaluations.
• Act as a subject matter expert during internal and external regulatory audits.
• Identify and implement process improvements related to quality, safety, productivity, manufacturing yield and operational efficiency.
• Collaborate with external suppliers and technical partners to assess new materials, consumables and manufacturing technologies.
• Support data collection, statistical trend analysis and continuous process verification activities.
• Contribute to knowledge sharing and technical expertise development within multidisciplinary teams.

Requirements:

• Master’s degree in Biotechnology, Bioengineering, Pharmaceutical Sciences, Life Sciences or a related scientific discipline.
• Minimum 3 years of relevant experience within a GMP regulated manufacturing, quality or development environment in the biotechnology or biopharmaceutical industry.
• Demonstrated experience with process validation and manufacturing process qualification.
• Good understanding of aseptic manufacturing processes, contamination control principles and sterility assurance.
• Strong knowledge of GMP regulations, validation requirements and quality management procedures.
• Experience preparing and reviewing validation protocols, reports, risk assessments and technical documentation.
• Familiarity with process validation activities such as PPQ, aseptic process simulations, smoke studies or filter integrity testing.
• Experience with deviation investigations, root cause analysis, change controls and CAPAs.
• Understanding of manufacturing process optimisation, process robustness and continuous improvement methodologies.
• Knowledge of statistical analysis and relevant software tools is an advantage.
• Strong analytical thinking, problem solving abilities and a structured approach to