Qualification & Validation Technician
ALTEN · Lisbonne
Descrição do cargo
About the role
ALTEN Portugal is seeking a detail‑oriented Qualification & Validation Technician to support equipment qualification and validation activities in GMP‑regulated environments. You will work on IQ/PQ protocols, calibration and validation tests, and ensure technical documentation meets regulatory standards.
Key responsibilities
- Support equipment suppliers in external IOPQ protocols and approve related documentation.
- Perform and execute internal IOPQ protocols.
- Create and update internal documentation such as SOPs, master lists, reports, and assessment reports.
- Conduct calibration tests (temperature, pressure, speed, conductivity, etc.).
- Support and carry out validation tests, including temperature distribution studies, HEPA filter tests, and qualification runs.
Required profile
- Bachelor’s degree in Engineering, Pharmaceutical Engineering, Industrial Engineering, or a related technical field.
- Minimum 1 year of experience in equipment qualification, validation activities, or GMP‑regulated engineering projects.
- Strong analytical and problem‑solving abilities with high attention to technical detail and documentation accuracy.
- Ability to work effectively in multidisciplinary teams and collaborate on technical reviews without direct leadership responsibilities.
- Familiarity with industry standards and regulatory requirements is highly valued.
Required skills
- Execution of IQ/PQ (Installation & Performance Qualification) protocols.
- Equipment calibration (temperature, pressure, speed, conductivity).
- Validation testing (temperature distribution studies, HEPA filter testing, qualification runs).
- Preparation and maintenance of technical documentation (SOPs, master lists, reports).
- Knowledge of GMP regulations and compliance.
What we offer
- Opportunity to work with cutting‑edge technology in the Life Sciences industry.
- Collaborative and dynamic work environment.
- Access to continuous training and professional development.
- Participation in diverse and interesting projects within a leading engineering company.
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ALTEN
Lisbonne
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