Validation Engineer – Pharmaceutical Industry

Function

As a Validation Engineer – Pharmaceutical Industry, you are part of a multidisciplinary team within Manufacturing Science & Technology (MSAT). You are responsible for developing, executing and optimising validation activities within a GMP-regulated production environment. In doing so, you combine process validation and quality assurance with technical support and continuous process improvement.

• Developing, executing and following up on validation activities for pharmaceutical production processes and production equipment.
• Drafting, reviewing and executing validation protocols, reports and associated GMP documentation.
• Contributing to the drafting and maintenance of the Validation Master Plan.
• Supporting qualification and validation activities during the implementation of new production processes and technologies.
• Executing and following up on validation studies, including Process Performance Qualification (PPQ), aseptic process validation, filter integrity testing and stability studies.
• Drawing up process risk analyses and assessing the impact of technical or operational changes.
• Handling and following up on deviations, CAPAs (Corrective and Preventive Actions) and Change Controls.
• Performing root cause analyses and proposing corrective and preventive measures.
• Monitoring compliance with GMP guidelines and internal quality procedures.
• Collaborating with various stakeholders within Production, Quality Assurance, Engineering and Technical Operations.
• Supporting internal and external audits and inspections based on your expertise in process validation.
• Analysing process data and identifying areas for improvement in terms of quality, safety, efficiency and yield.
• Contributing to process optimisations, technology transfers and the further expansion of production capacity.
• Supporting validation activities within an innovative Cell & Gene Therapy production environment.

Profile

For this role as Validation Engineer - Pharmaceutical Industry, we are looking for an analytical and precise professional with a strong scientific background and at least three years of experience within a GMP-regulated environment. You combine technical expertise with a quality-driven approach and communicate effectively with various stakeholders.

• You hold a master's degree in a scientific discipline, such as bio-engineering, biotechnology, biomedical sciences, pharmaceutical sciences, chemistry or equivalent.
• You have at least 3 years of relevant experience within a GMP-regulated environment, preferably within Manufacturing, Quality, Development or MSAT.
• You have experience with process validation and/or qualification of production equipment within the pharmaceutical or biotechnological sector.
• You possess knowledge of Cell & Gene Therapy, gained during your studies or professional career.
• You are familiar with aseptic processes and sterile production environments.
• You have knowledge of validation methodologies, risk analyses and GMP documentation.
• You have experience in handling deviations, CAPAs and Change Controls.
• Experience with statistical analyses and software such as JMP is an advantage.
• You possess strong analytical and problem-solving skills.
• You are able to translate complex technical information into practical and feasible solutions.
• You communicate effectively with various stakeholders and enjoy working in a multidisciplinary environment.
• You are proactive, results-driven, precise and quality-conscious.
• A good knowledge of Dutch is an absolute must. In addition, you are able to express yourself professionally in English.

Organisation

You will join a specialised consultancy organisation that is active within the pharmaceutical, biotechnological and life sciences sector. The organisation supports leading companies in complex scientific and technical projects, with a strong focus on process validation, quality assurance, GMP compliance and continuous improvement.

As a Validation Engineer - Pharmaceutical Industry, you will be deployed at an innovative biotechnological production environment in Zwijnaarde, where advanced cell and gene therapies are developed and produced. You will contribute to projects that support the further development and optimisation of groundbreaking treatments.

The organisation offers its employees the security of a permanent contract, combined with challenging consultancy projects, personal guidance and extensive training opportunities. You will have the chance to further develop your expertise within a high-tech environment where innovation, collaboration and professional development are central.

This concerns a long-term consultancy project with an anticipated duration until the end of 2027.

Offer

As a Validation Engineer - Pharmaceutical Industry, you can count on an attractive salary package, supplemented by extensive fringe benefits. In addition, the organisation actively invests in your professional development and you will have the opportunity to contribute to innovative projects within the pharmaceutical and biotechnological sector.

• Permanent contract from day one.
• Gross monthly salary between € 3,000 and € 4,000, depending on your experience and expertise.
• Premium company car with fuel or charging card.
• Net expense allowance.
• Meal vouchers of €8 per day worked.
• Hospitalisation insurance.
• Group insurance.
• Eco-vouchers worth €250 a year.
• Paid mobile phone subscription.
• 40-hour week with 12 ADV days.
• Extensive training programme funded by the employer.