Project Engineer for sterile manufacturing

ROXALL Medicina España; Zamudio; Presencial; EUR 40.000 - 50.000; Jornada completa

Descripción de la vacante

Una empresa en el sector de la investigación y fabricación de vacunas busca un Ingeniero de Proyectos para la fabricación estéril. Este rol implica supervisar actividades relacionadas con el mantenimiento industrial y la implementación de mejoras de ingeniería dentro de un entorno regulado por GMP. Se requiere experiencia previa en mantenimiento industrial, formación en ingeniería y conocimientos en normas GMP e ISO.

Formación

• Mínimo 3 años de experiencia en mantenimiento industrial.
• Conocimientos técnicos en proyectos industriales y regulaciones GMP.
• Nivel de inglés mínimo C1; preferiblemente conocimiento de alemán.

Responsabilidades

• Apoyar en la planificación y supervisión de actividades de mantenimiento.
• Colaborar en gestión de proyectos de mejora de instalaciones.
• Asegurar la disponibilidad de equipos críticos cumpliendo los estándares de calidad.

Conocimientos

Gestión de proyectos

Conocimientos técnicos en regulación GMP

Comunicación efectiva

Educación

Grado en Ingeniería Industrial o similar

Herramientas

Sistemas de gestión de calidad

Descripción del empleo

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 Project Engineer for sterile manufacturing 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. Support the Head of Engineering and Maintenance in the planning, supervising and executing activities related to preventive, corrective and predictive maintenance, as well as implementing engineering improvements and executing new installations from the design phase to commissioning, ensuring compliance with GMP standards and applicable regulations in the pharmaceutical sector, actively participating in the design, execution, 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, vorzugsweise mit fließenden Deutschkenntnissen.

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.