Project Engineer - Clean Utilities (Water For Injection)

Pqe Group; Madrid; Presencial; EUR 41.000 - 50.000; Jornada completa

Descripción de la vacante

PQE Group in Madrid is seeking a Project Engineer / Project Manager to support a strategic GMP-regulated pharmaceutical manufacturing project. You will coordinate execution, manage external contractors, ensure GMP compliance, and contribute to validation, change control, and QA/documentation.

The assignment starts September 2026 in Tres Cantos and extends through December 2027, after which related projects in Madrid will follow.

Formación

• Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Industrial, Pharmaceutical, or related)
• Experience managing or supporting engineering projects in the pharmaceutical, biotech, or life sciences industry
• Experience working in GMP-regulated environments
• Familiarity with Clean Utilities and Water for Injection (WFI)
• IQ/OQ/PQ qualification and validation activities desirable
• Experience with Change Control, Deviations, CAPA, and documentation management
• Ability to coordinate multiple stakeholders, including external contractors
• Fluent English; native-level Spanish required

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 on-time and within-scope delivery
• Coordinate and oversee daily activities of external contractors and engineering partners
• Ensure activities comply with GMP requirements and internal quality standards
• Establish and maintain Change Controls, Deviations, and CAPA processes
• Support preparation of validation and regulatory documentation
• Develop and revise SOPs and controlled documentation
• Collaborate with cross-functional teams (Engineering, Manufacturing, QA/Compliance, EHS)
• Monitor progress, identify risks, and implement mitigating actions
• Minimize disruption to ongoing manufacturing operations

Conocimientos

Project management

Regulatory compliance

Cross-functional coordination

Communication

Educación

Bachelor's or Master's degree in Engineering

Herramientas

IQ/OQ/PQ

Clean Utilities knowledge

Descripción del empleo

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

We are looking for a Project Engineer / Project Manager to support the delivery of a strategic engineering project within a GMP-regulated pharmaceutical manufacturing environment. The successful candidate will work closely with the Project Manager, coordinating project execution while ensuring compliance with quality and regulatory requirements throughout the project lifecycle.

Although the position is based in Madrid, the initial project assignment will start on September 2026 , and run through December 2027 . During this period, the role will be based in Tres Cantos, Madrid . Upon completion of the project, the candidate will be assigned to other engineering projects based at our Madrid office.

Responsibilities include, but are not limited to:

• Support the Project Manager in planning, coordinating, and executing engineering projects in a GMP environment.
• Assist in the delivery of a new 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 the implementation of mitigation actions.
• Ensure project execution minimizes disruption to ongoing manufacturing operations.

Required Qualifications

• Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Industrial, Pharmaceutical, or related discipline).
• Previous experience managing or supporting engineering projects within the pharmaceutical, biotech, or life sciences industry.
• Experience working in GMP-regulated environments .
• Basic technical knowledge of Clean Utilities , with particular 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.
• Strong organizational, communication, and problem-solving skills.
• Fluent English is required; native-level Spanish is required.
• Permanent employment with long-term career opportunities.
• Salary starts from 45.000€ gross per year

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.