ABOUT US:
We are dedicated to the research, design, validation, manufacture, and distribution of anti-allergic vaccines (immunotherapy sector).
We have a headquarters for our Technical, R&D, and Clinical Trials divisions in Zamudio, which is currently our only production facility. In this regard, we anticipate significant growth.
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 Project Engineer for sterile manufacturing to join our team (temporary position with the possibility of becoming permanent). He or she will report to the Head of Engineering and Maintenance and will provide support to the team within the Industrial Area.
Mission:
Support the Head of Engineering and Maintenance in planning, supervising, and executing activities related to preventive, corrective, and predictive maintenance, as well as implementing engineering improvements and overseeing new installations from the design phase through commissioning, ensuring compliance with GMP standards and applicable regulations in the pharmaceutical sector, and actively participating in the design, implementation, validation, and commissioning of new critical systems and installations.
Main tasks and responsibilities:
- Collaborate on the management of projects aimed at improving, modifying, or expanding industrial facilities and systems, from the design phase through to commissioning.
- Coordinate with contractors, architects, external engineering firms, and suppliers to ensure compliance with technical specifications, deadlines, and GMP regulations.
- Supervise the progress of civil works, electromechanical installations, utilities (HVAC, purified water, clean steam, compressed air, etc.), and critical systems on site.
- Collaborate in the review and approval of plans, technical specifications, URS, and design documents.
- Help prepare operating manuals, standard operating procedures (SOPs), and documentation for regulatory approvals.
- Ensure the availability and proper functioning of critical equipment in accordance with quality and safety standards.
- Ensure compliance with GMP, ISO, and local and international regulations.
Requirements:
- Bachelor’s degree in Industrial Engineering or a related field
- At least 3 years of experience in industrial maintenance, preferably in pharmaceutical, hospital, or food processing facilities. Experience in the execution of industrial and construction projects in the pharmaceutical, hospital, or food processing industries.
- Technical expertise in the design and implementation of industrial projects and critical facilities, including: air conditioning, water systems (PW, WFI), compressed air, clean steam, industrial automation, clean rooms, pharmaceutical process equipment (freeze dryers, autoclaves, dosing machines, etc.), and GMP regulations pertaining to facilities.
- Minimum English proficiency level C1, preferably with fluent German skills.
Salary terms:
Based on the candidate’s profile, in accordance with the industry and responsibilities of the position.
Observations:
We are seeking a creative and results-driven technician with a firm yet empathetic leadership style, who is accustomed to building relationships based on trust within their team and collaborating across departments.
