ABOUT US:
We are dedicated to the research, design, validation, manufacture and distribution of anti-allergic vaccines (immunotherapy sector).
We have a Technical, R&D and Clinical Trials headquarter in Zamudio, our only production centre for the moment. In this sense, we have a strong growth forecast.
Our value proposition for employees is as follows:
- PEOPLE-CENTRIC: We focus on people.
- SELF-DEMANDING PEOPLE: We promote individual self-demand in pursuit of common achievement.
- CURIOUS PEOPLE: We learn by innovating, valuing the experience that each person can bring to the organisation.
ABOUT THE JOB:
We are looking for a Qualifications and Calibrations Technician ( Zamudio ) to join our team. He/She will report to the Head of Engineering and Maintenance and will provide support to the group within the Industrial Area.
Mission. Coordinate and ensure the correct execution of qualification and calibration activities for critical equipment, facilities, and services carried out by external suppliers, guaranteeing compliance with Good Manufacturing Practices (GMP/BPM) and applicable regulatory requirements. Be the technical manager of the plant’s qualification and calibration plans.
Main tasks and responsibilities:
- Plan, coordinate and monitor qualification (IQ, OQ, PQ) and calibration activities carried out by contractors and external laboratories.
- Ensure that activities are carried out in accordance with internal procedures, master plans, schedules and regulatory standards.
- Technically validate protocols, reports, certificates, and documentation provided by suppliers, ensuring their integrity, traceability, and compliance.
- Keep Qualification and Calibration Plans and associated schedules up to date.
- Coordinate interventions with different areas of the company to minimise the impact on operations.
- External supplier management, documentation validation (protocols, certificates, reports) and management of deviations, changes and CAPAs.
Requirements:
- Degree in industrial engineering and/or biology/chemistry/pharmacy or similar with specific complementary training
- At least two years’ experience in the pharmaceutical, cosmetics, biotechnology or medical device industry coordinating or managing qualification and calibration services
- Advanced knowledge of GMP / NOM-059-SSA1 / FDA 21 CFR Part 11 / ISO 17025 regulations
- Previous experience in equipment and facility validation projects is desirable
- Advanced computer skills
- Fluency in English, minimum C1 (desirable, minimum A1 German)
Salary conditions: According to the candidate’s profile, in line with the sector and functions of the position.
Observations: We are looking for a creative and achievement-oriented technician, with a firm but empathetic leadership style, used to developing relationship models based on trust within his team and to work transversally with the rest of the areas.
