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 organization.
ABOUT THE JOB:
We are looking for a Qualifications and Calibrations Technicianto join our team. He or she will report to the Head of Engineering and Maintenance and will provide support to the team within the Industrial Area.
Mission. Coordinate and ensure the proper execution of qualification and calibration activities for critical equipment, facilities, and services performed by external suppliers, ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulatory requirements. Serve as the technical manager for the plant’s qualification and calibration plans.
Main tasks and responsibilities:
- Plan, coordinate, and monitor qualification (IQ, OQ, PQ) and calibration activities performed by contractors and external laboratories.
- Ensure that activities are conducted in accordance with internal procedures, master plans, schedules, and regulatory standards.
- Technically validate protocols, reports, certificates, and documentation provided by suppliers to ensure their integrity, traceability, and compliance.
- Keep qualification and calibration plans and their associated schedules up to date.
- Coordinate efforts with various departments within the company to minimize 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 a related field, with specific complementary training
- At least two years of 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 preferred
- 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.
