Vacature - Jouw nieuwe functie
Senior Validation Engineer
QTC Recruitment is searching for a Senior Validation Engineer to manage and oversee the site validation system, ensuring compliance with quality standards, cGMP, and regulatory requirements. The role focuses on leading qualification and validation activities, maintaining inspection readiness, and driving continuous improvement.
Details
Medical Devices
Engineering
Nijmegen - Netherlands
40 uur per week
leer ons kennen
Jouw consultant
Over jouw rol
Zo maak jij het verschil
Key ResponsibilitiesValidation System Management
- Manage and maintain the site validation system in line with quality objectives.
- Own and maintain the Validation Master Plan (VMP) and related procedures.
- Ensure processes, materials, equipment, utilities, and facilities are qualified and validated.
- Maintain inspection readiness for internal and external audits.
- Ensure compliance with ISO, cGMP, and global quality standards.
- Lead qualification and validation activities.
- Draft and review protocols and reports (equipment, facilities, utilities, process validation/verification, cleaning validation).
- Review TMV and CSV documentation.
- Manage risk assessments, traceability matrices, deviations, and validation reports.
- Oversee validation deviations and maintain VD logbook.
- Establish KPIs and monitor validation performance.
- Develop continued process verification and annual monitoring strategies.
- Track validation-related NCs and CAPAs to ensure timely closure.
- Ensure ongoing GMP and regulatory compliance.
- Drive validation process improvements.
- Implement best practices, tools, and technologies.
- Promote a culture of quality and continuous improvement.
Wat nodig is
Wat jij mee brengt
Qualifications
- Bachelor’s or Master’s degree in Engineering, Manufacturing, or related field.
- Minimum 5 years of validation experience.
- Experience with Class III sterile medical devices preferred.
- Strong knowledge of ISO 13485, ISO 14971, cGMP, and ISPE C&Q principles.
- Medical device or pharmaceutical industry experience preferred.
- Project management experience.
- Fluent in English (Dutch preferred).
- Strong communication and organizational skills.
Wat wij bieden
Jouw voordelen
Offer details:
- Competitive salary package
- Performance-based bonus
- Pension scheme
- Travel allowance
- 25+ vacation days
- Professional development and training opportunities
- Dynamic, international working environment
WORD JE ENTHOUSIAST VAN DEZE FUNCTIE?