ABOUT US:
We are dedicated to the research, design, validation, manufacture, and distribution of anti-allergy vaccines (immunotherapy sector).
We have a Technical, R&D and Clinical Trials headquarter in Zamudio, our only production center 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 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 carrying out 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 in the management of projects for the improvement, modification or expansion of industrial facilities and systems, from the design phase to commissioning.
- Coordinate with contractors, architects, external engineering companies 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.
- Participate in the preparation of operating manuals, standard operating procedures (SOPs) and documentation for regulatory approvals.
- Ensure the availability and operability 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 similar
- Minimum 3 years of experience in industrial maintenance, preferably in pharmaceutical, hospital or food plants. Experience in the execution of industrial and construction projects in the pharmaceutical/hospital/food industry.
- Technical knowledge in the design and execution of industrial projects, critical facilities: 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 relating to facilities.
- Minimum English level C1, preferably with fließenden Deutschkenntnissen.
Salary terms:
Based on the candidate’s profile, taking into account the industry and responsibilities of the position.
Notes:
We are looking for a creative and results-oriented technician with a firm yet empathetic leadership style, who is accustomed to building trusting relationships within their team and collaborating across departments.
