GMP Clean Utilities Project Engineer (WFI) - Madrid

PQE Group; Madrid; Presencial; EUR 40.500 - 49.500; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Permanent employment

Descripción de la vacante

PQE Group seeks a Project Engineer / Project Manager to support a strategic GMP-regulated pharmaceutical project in Madrid. You will coordinate execution with the Project Manager, ensuring compliance with quality and regulatory standards throughout the lifecycle.

The role starts in Madrid with the initial assignment in Tres Cantos from Sep 2026 to Dec 2027, after which it transitions to other engineering projects at the Madrid office. English and Spanish are essential.

Formación

• Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Industrial, Pharmaceutical, or related).
• Experience managing or supporting engineering projects within the pharmaceutical, biotech, or life sciences industry.
• Experience working in GMP-regulated environments.
• Basic knowledge of Clean Utilities, with emphasis on Water for Injection (WFI).
• Familiarity with qualification and validation activities (IQ/OQ/PQ) is highly desirable.
• Experience with Change Control, Deviations, CAPA, and documentation management.
• Ability to coordinate multiple stakeholders, including external contractors.
• Fluent English is required; native-level Spanish is required.
• Permanent employment with long-term career opportunities.
• Salary starts from 45.000€ gross per year.

Responsabilidades

• Support the Project Manager in planning, coordinating, and executing engineering projects in a GMP environment.
• Assist in the delivery of a Water for Injection (WFI) generation project, ensuring activities are completed safely, on time, and within scope.
• Coordinate and oversee the daily activities of external contractors and engineering partners.
• Ensure project activities comply with GMP requirements and internal quality standards.
• Establish and maintain Change Controls, Deviations, and CAPA processes.
• Support the preparation of validation and regulatory documentation.
• Contribute to the development and revision of SOPs and controlled documentation.
• Collaborate with cross-functional teams including Engineering, Manufacturing, Quality Assurance/Compliance, and EHS.
• Monitor project progress, identify risks, and support mitigation actions.
• Ensure project execution minimizes disruption to ongoing manufacturing operations.

Conocimientos

Project coordination

Cross-functional collaboration

Strong organizational skills

Communication skills

GMP experience

Educación

Bachelor's or Master's degree in Engineering

Descripción del empleo

PQE Group seeks a Project Engineer / Project Manager to support a strategic GMP-regulated pharmaceutical project in Madrid. You will coordinate execution with the Project Manager, ensuring compliance with quality and regulatory standards throughout the lifecycle.

The role starts in Madrid with the initial assignment in Tres Cantos from Sep 2026 to Dec 2027, after which it transitions to other engineering projects at the Madrid office. English and Spanish are essential.