Quality Engineer

Closing date vacancy 1-12-2026

Are you an experienced Quality Engineer with expertise in validation, supplier qualification and cleanroom monitoring? Would you like to play a key role in ensuring the quality of radiopharmaceutical products? We are looking for a Quality Engineer to monitor and continuously improve our processes from a QA perspective.

Your role

In this role, you will be responsible for overseeing the quality of cleanroom processes, supplier qualification and validation activities. You will ensure that submitted documentation is complete and accurate by thoroughly reviewing and approving it. You will assess the technical aspects of processes and systems from a quality and compliance perspective, ensuring that they meet internal standards and applicable GMP requirements.

You will also act as the first point of contact for deviations in cleanroom processes and coordinate the necessary follow-up actions to ensure compliance. You will review and approve changes, CAPAs and deviations related to validation, quality processes or cleanroom activities. In addition, you will contribute to quality risk assessments, such as FMEAs, to support compliance.

Your responsibilities

- Review and approve validation protocols and reports (SAT/IQ/OQ/PQ).
- Prepare environmental monitoring reports and identify deviations.
- Act as the first point of contact for issues in the cleanroom environment and coordinate follow-up actions.
- Manage and review supplier qualifications and contribute to periodic supplier evaluations.
- Oversee compliance with GMP, ISO standards and regulations applicable to radiopharmaceutical products.
- Contribute to risk assessments, such as FMEAs, and CAPA processes.
- Conduct supplier audits as part of supplier qualification.
- Conduct internal audits to verify compliance with GMP and quality requirements.
- Support regulatory inspections, including preparation and follow-up of resulting actions.
- Work with Production, Engineering and external parties to safeguard quality and safety.
- Review quality processes and documentation throughout the product lifecycle, including change control, CAPAs, deviations and quality reviews.
- Participate in or support quality risk assessments, such as FMEAs, to identify issues and implement risk-based solutions.

Your profile

- A completed technical or scientific degree at bachelor’s or master’s level, for example in Chemistry, Biotechnology or a related field.
- Experience with validation in a GMP environment is essential.
- At least five years of quality management experience in the pharmaceutical industry.
- Thorough knowledge of validation processes, environmental monitoring and supplier qualification.
- Knowledge of cleanroom environments with both positive and negative pressure regimes.
- Analytical and critical, with an eye for detail and a proactive, solution-oriented approach.
- Excellent communication skills in Dutch and/or English.
- Experience conducting internal and supplier audits; lead auditor experience is an advantage.
- Experience with radiopharmaceutical products is an advantage.
- A Certificate for the Transport of Dispersible Radioactive Substances (TMS VRS-D), or willingness to obtain it within one year.

What we offer

- A challenging and responsible role within an innovative company.
- A market-competitive salary and excellent secondary benefits.
- Opportunities for professional development and training.
- A stimulating work environment with committed colleagues, in a modern facility equipped with advanced alpha and beta hot cells.
- Flexibility and the opportunity to contribute to life-saving products.

Application deadline: 01-Dec-2026