Project Engineer – Clean Utilities (Water for Injection)

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

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

• 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

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome from the Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.